Safety and Antitumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma

• Sponsor: ADC Therapeutics S.A. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03685344
• Collaborator: (none)
• Enrollment: 13
• Locations: 14
• Arm: 1
• Actual Duration (Months): 20.7
• Patients Per Site: 0.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this phase 1 study is to evaluate the safety and anti-tumor activity of Loncastuximab Tesirine (ADCT-402) and Durvalumab in participants with Advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-Cell Lymphoma; Mantle Cell Lymphoma; Follicular Lymphoma	Drug: Loncastuximab Tesirine and Durvalumab	Phase 1

Detailed Description

This is a Phase 1b, open-label, single-arm combination study with a dose escalation phase (Part 1) followed by a dose expansion phase (Part 2). The study will enroll approximately 75 participants.

A standard 3+3 dose escalation design will be used for Part 1. The DLT period will be the 21 days after the first durvalumab dose.

Part 2 will consist of up to 3 expansion cohorts, one for DLBCL, one for MCL, and one for FL. Each cohort will be approximately 20 participants treated at the dose determined in Part 1.

The study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3, 6, and 4 weeks), and a Follow-up Period (approximately every 12 week visits for up to 2 years after treatment discontinuation).

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Open-Label Study to Evaluate the Safety and Antitumor Activity of Loncastuximab Tesirine and Durvalumab in Patients With Advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
• Actual Study Start Date: Feb 4, 2019
• Actual Primary Completion Date: Oct 27, 2020
• Actual Study Completion Date: Oct 27, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: ADCT-402 Dose escalation phase: Ascending doses of Loncastuximab tesirine will be administered using a traditional 3+3 design. Dose level 1: 90 µg/kg, every 3 weeks (Q3W). Dose level 2: 120 µg/kg, Q3W. Dose level 3: 150 µg/kg, Q3W. Loncastuximab tesirine will be given for 2 doses, 3 weeks apart. Dose expansion phase: Loncastuximab tesirine will be administered at the recommended dose determined in the dose escalation phase. Durvalumab will also be administered at a dose of 1500 mg once every 4 weeks (Q4W) throughout the dose escalation phase and dose expansion phase.

Drug: Loncastuximab Tesirine and Durvalumab; intravenous infusion; Other Names: ADCT-402 in combination with Durvalumab Zynlonta

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Treatment-emergent Adverse Event (TEAE) [Day 1 to 30 days after the last dose of study drugs (maximum treatment duration at study termination was 336 days)]

   A TEAE was defined as an adverse event (AE) that occurred or worsened in the period extending from the first dose of study drugs to 30 days after the last dose of study drugs or initiation of new anti-cancer therapy (whichever occurred earlier). Evaluation of TEAEs included the number of participants with at least one: TEAE, serious TEAE and grade ≥3 TEAE as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 CTCAE grading scale: Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 = Life-threatening consequences; urgent intervention indicated. Grade 5 = Death related to AE. Clinically significant changes from baseline for safety laboratory values, vital sign measurements and electrocardiograms (ECGs) were recorded as TEAEs.

2. Number of Participants With a Dose-limiting Toxicity [21 days after first dose of durvalumab (Day 8 to Day 29)]

   DLTs were defined as specific events which occurred in the 21-day DLT evaluation period of the dose escalation part, except any events that were clearly due to underlying disease or extraneous causes. The grading and severity of events were based on the guidelines provided in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

3. Number of Participants With a Treatment-emergent Adverse Event Leading to Dose Interruption or Reduction [Day 1 to end of treatment (maximum treatment duration at study termination was 336 days)]

4. Number of Participants With Changes From Baseline on the Eastern Cooperative Oncology Group (ECOG) Performance Status [Day 1 to end of treatment (maximum treatment duration at study termination was 336 days)]

   Eastern Cooperative Oncology Group (ECOG) performance status was scored on a 6-point scale where higher scores indicate a worse outcome. ECOG scores included the following: 0 = fully active, able to carry on all pre-disease performance without restriction 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 = ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours 3 = capable of only limited self-care; confined to bed or chair more than 50% of waking hours 4 = completely disabled; cannot carry on any self-care; totally confined to bed or chair 5 = dead

Secondary Outcome Measures

1. Overall Response Rate (ORR) [Up to 1.5 years]

   ORR according to the 2014 Lugano classification as determined by the investigator. Overall response rate was the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as achieving each of the following: Complete metabolic response. Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology). PR was defined as achieving each of the following: Partial metabolic response (findings indicate residual disease). Partial remission (>50% decrease in target measurable nodes, regression/ absence/ no increase of non-measured lesions, spleen regressed by >50% in length and no new lesions).

2. Duration of Response (DOR) [Up to 1.5 years]

   DOR was defined as the time from the documentation of first tumor response (CR or PR) to disease progression or death. CR was defined as achieving each of the following: Complete metabolic response. Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology). PR was defined as achieving each of the following: Partial metabolic response (findings indicate residual disease). Partial remission (>50% decrease in target measurable nodes, regression/ absence/ no increase of non-measured lesions, spleen regressed by >50% in length and no new lesions).

3. Complete Response Rate (CRR) [Up to 1.5 years]

   CRR was defined as the percentage of participants with a BOR of CR, according to the 2014 Lugano classification, as determined by the investigator. CR was defined as achieving each of the following: Complete metabolic response. Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).

4. Relapse-free Survival (RFS) [Up to 1.5 years]

   RFS was defined as the time from the documentation of CR to disease progression or death. CR was defined as achieving each of the following: Complete metabolic response. Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology). Disease progression was defined as progressive metabolic disease and one of the following: Target node progression. An individual extranodal lesion must be abnormal with length > 1.5cm and/or increase of length > 50%. New or clear progression of non-measured lesions. Regrowth of previously resolved lesions or new nodes >1.5 cm in length. New or recurrent bone marrow involvement.

5. Progression-free Survival (PFS) [Up to 1.5 years]

   PFS was defined as the time between start of treatment and the first documentation of progression, or death. Disease progression was defined as progressive metabolic disease and one of the following: Target node progression. An individual extranodal lesion must be abnormal with length > 1.5cm and/or increase of length > 50%. New or clear progression of non-measured lesions. Regrowth of previously resolved lesions or new nodes >1.5 cm in length. New or recurrent bone marrow involvement.

6. Overall Survival (OS) [Up to 1.5 years]

   OS was defined as the time between the start of treatment and death from any cause.

7. Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 [Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15]

   Cmax of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. Cmax of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.

8. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 [Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15]

   AUC0-last of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. AUC0-last of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.

9. Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 [Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15]

   AUCinf of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. AUCinf of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.

10. Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 [Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15]

    Thalf of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. Thalf of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.

11. Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 [Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15]

    CL for Cycle 2 reflects steady-state clearance. CL of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2.

12. Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199 [Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15]

    Vss of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2.

13. Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody and Total Antibody [Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15]

    AI is the ratio of drug accumulation after repeated administration compared to a single dose. AI of loncastuximab tesirine conjugated antibody and total antibody was calculated from Cycles 1 and 2.

14. Number of Participants With an Anti-drug Antibody (ADA) Response to Loncastuximab Tesirine [Cycle 1 (= 3 weeks): Day 1 pre-dose & Day 15; Cycles 2, 3, 5, 6, & 7 (Cycle 2 = 6 weeks, other cycles = 4 weeks): Day 1 pre-dose; 30 days after last dose of study drugs]

    Detection of ADAs were performed by using a screening assay for identification of antibody positive samples/patients, a confirmation assay, and titer assessment, and were performed using the Meso-Scale Discovery Electrochemiluminescence platform.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female participants aged 18 years or older

2. Pathologic diagnosis of DLBCL, MCL, or FL

3. Participants must have relapsed or refractory disease and have failed or been intolerant to standard therapy

4. Participants who have received previous CD19-directed therapy must have a biopsy that shows CD19 expression after completion of the CD19-directed therapy

5. Measurable disease as defined by the 2014 Lugano Classification

6. Participants must be willing to undergo tumor biopsy

7. ECOG performance status 0-1

8. Screening laboratory values within the following parameters:

9. Absolute neutrophil count (ANC) ≥1.0 × 103/µL (off growth factors at least 72 hours)

10. Platelet count ≥75 × 103/µL without transfusion in the past 7 days

11. Hemoglobin ≥9.0 g/dL (5.59 mmol/L), transfusion allowed

12. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and GGT ≤2.5 × the upper limit of normal (ULN)

13. Total bilirubin ≤1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN)

14. Blood creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min by the Cockcroft-Gault equation

15. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 3 days prior to start of study drug on C1D1 for women of childbearing potential

16. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of study therapy. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of study therapy

Exclusion Criteria:

1. Known history of hypersensitivity to or positive serum human ADA to a CD19 antibody.

2. Previous therapy with any checkpoint inhibitor

3. Autologous stem cell transplant within 100 days prior to start of study drug (C1D1)

4. History of allogenic stem cell transplant

5. History of solid organ transplant

6. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:

7. Participants with vitiligo or alopecia

8. Participants with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement

9. Any chronic skin condition that does not require systemic therapy

10. Participants without active disease in the last 5 years may be included but only after consultation with the Study Physician

11. Participants with celiac disease controlled by diet alone

12. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice)

13. Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV)

14. History of Stevens-Johnson syndrome or toxic epidermal necrolysis

15. Lymphoma with active central nervous system (CNS) involvement at the time of screening, including leptomeningeal disease

16. Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)

17. Breastfeeding or pregnant

18. Significant medical comorbidities, including but not limited to, uncontrolled hypertension (blood pressure [BP] ≥160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease

19. Radiotherapy, chemotherapy, or other anti-neoplastic therapy within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor.

20. Major surgery within 28 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor. Note: Local surgery of isolated lesions for palliative intent is acceptable.

21. Use of any other experimental medication within 14 days prior to start of study drug (C1D1)

22. Planned live vaccine administration after starting study drug (C1D1)

23. Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) from acute non-hematologic toxicity (Grade ≤2 neuropathy or alopecia) due to previous therapy prior to screening.

24. Congenital long QT syndrome or a corrected QTcF interval of >470 ms at screening (unless secondary to pacemaker or bundle branch block)

25. History of another primary malignancy except for:

26. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of investigational product and of low potential risk for recurrence

27. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease

28. Adequately treated carcinoma in situ without evidence of disease 21. History of active primary immunodeficiency

29. History of active primary immunodeficiency or any other significant medical illness, abnormality, or condition that would, in the Investigator's judgement, make the patient inappropriate for study participation or put the participant at risk.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	UCH-MHS Memorial Hospital Centeral	Colorado Springs	Colorado	United States	80909
3	University of Florida Health Shands Cancer Hospital	Gainesville	Florida	United States	32603
4	University of Miami - Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136
5	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08901
6	Icahm School of Medicine at Mount Sinai	New York	New York	United States	10029
7	Baylor University Medical Center	Dallas	Texas	United States	75246
8	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas	United States	79410
9	Baylor Scott & White Medical Center - Temple	Temple	Texas	United States	76508
10	Hospital Clinic de Barcelona	Barcelona		Spain	08036
11	Hospital General Universitario Gregorio Marañon Pabellón de Oncología	Madrid		Spain	28009
12	Hospital Universitario Fundación Jiménez Díaz Unidad de Limfomas Servicio de Hematologia	Madrid		Spain	28040
13	Hospital Universitario Virgen Macarena Servicio Oncologia Medica	Sevilla		Spain	41009
14	Hospital Universitario Virgen Del Rocio	Sevilla		Spain	41015

Sponsors and Collaborators

• ADC Therapeutics S.A.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 14, 2019
• Statistical Analysis Plan - Nov 2, 2020

More Information

Publications

None provided.

• Responsible Party: ADC Therapeutics S.A.
• ClinicalTrials.gov Identifier: NCT03685344
• Other Study ID Numbers: ADCT-402-104; 2018-002670-43
• First Posted: Sep 26, 2018
• Last Update Posted: Oct 26, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ADC Therapeutics S.A.: Loncastuximab Tesirine in Combination with Durvalumab
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Durvalumab; Loncastuximab tesirine; Antibodies, Monoclonal

Study Results

Participant Flow

Recruitment Details	13 participants were enrolled at 5 sites in the United States and 3 sites in Spain between February 2019 and October 2020.
Pre-assignment Detail	16 participants had signed informed consent, however 3 were considered screen failures. The remaining 13 participants were enrolled and received study treatment.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Period Title: Overall Study
STARTED	3	3	7	0
Received Treatment	3	3	7	0
COMPLETED	0	0	0	0
NOT COMPLETED	3	3	7	0

Baseline Characteristics

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine	Total
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.	Total of all reporting groups
Overall Participants	3	3	7	0	13
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.0 (15.00)	74.0 (2.00)	63.0 (16.94)	66.2 (14.24)
Sex: Female, Male (Count of Participants)
Female	1 33.3%	3 100%	2 28.6%	6 Infinity
Male	2 66.7%	0 0%	5 71.4%	7 Infinity
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 66.7%	0 0%	2 28.6%	4 Infinity
Not Hispanic or Latino	1 33.3%	3 100%	5 71.4%	9 Infinity
Unknown or Not Reported	0 0%	0 0%	0 0%	0 NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 NaN
Asian	0 0%	0 0%	0 0%	0 NaN
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 NaN
Black or African American	0 0%	0 0%	0 0%	0 NaN
White	3 100%	3 100%	5 71.4%	11 Infinity
More than one race	0 0%	0 0%	0 0%	0 NaN
Unknown or Not Reported	0 0%	0 0%	2 28.6%	2 Infinity

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Treatment-emergent Adverse Event (TEAE)
Description	A TEAE was defined as an adverse event (AE) that occurred or worsened in the period extending from the first dose of study drugs to 30 days after the last dose of study drugs or initiation of new anti-cancer therapy (whichever occurred earlier). Evaluation of TEAEs included the number of participants with at least one: TEAE, serious TEAE and grade ≥3 TEAE as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 CTCAE grading scale: Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 = Life-threatening consequences; urgent intervention indicated. Grade 5 = Death related to AE. Clinically significant changes from baseline for safety laboratory values, vital sign measurements and electrocardiograms (ECGs) were recorded as TEAEs.
Time Frame	Day 1 to 30 days after the last dose of study drugs (maximum treatment duration at study termination was 336 days)

Outcome Measure Data

Analysis Population Description

Safety analysis set - All participants who received the study drug. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	3	7	0
TEAE	3 100%	3 100%	7 100%
Serious TEAE	1 33.3%	2 66.7%	1 14.3%
CTCAE Grade ≥3 TEAE	2 66.7%	2 66.7%	5 71.4%

2. Primary Outcome

Title	Number of Participants With a Dose-limiting Toxicity
Description	DLTs were defined as specific events which occurred in the 21-day DLT evaluation period of the dose escalation part, except any events that were clearly due to underlying disease or extraneous causes. The grading and severity of events were based on the guidelines provided in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time Frame	21 days after first dose of durvalumab (Day 8 to Day 29)

Outcome Measure Data

Analysis Population Description

Safety analysis set - All participants who received the study drug. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	3	7	0
Count of Participants [Participants]	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Number of Participants With a Treatment-emergent Adverse Event Leading to Dose Interruption or Reduction
Time Frame	Day 1 to end of treatment (maximum treatment duration at study termination was 336 days)

Outcome Measure Data

Analysis Population Description

Safety analysis set - All participants who received the study drug. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	3	7	0
Loncastuximab Tesirine: Dose Interruption	0 0%	0 0%	0 0%
Loncastuximab Tesirine: Dose Reduction	0 0%	0 0%	0 0%
Durvalumab: Dose Interruption	0 0%	0 0%	0 0%
Durvalumab: Dose Reduction	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Number of Participants With Changes From Baseline on the Eastern Cooperative Oncology Group (ECOG) Performance Status
Description	Eastern Cooperative Oncology Group (ECOG) performance status was scored on a 6-point scale where higher scores indicate a worse outcome. ECOG scores included the following: 0 = fully active, able to carry on all pre-disease performance without restriction 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 = ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours 3 = capable of only limited self-care; confined to bed or chair more than 50% of waking hours 4 = completely disabled; cannot carry on any self-care; totally confined to bed or chair 5 = dead
Time Frame	Day 1 to end of treatment (maximum treatment duration at study termination was 336 days)

Outcome Measure Data

Analysis Population Description

Safety analysis set - All participants who received the study drug. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	3	7	0
Count of Participants [Participants]	2 66.7%	0 0%	1 14.3%

5. Secondary Outcome

Title	Overall Response Rate (ORR)
Description	ORR according to the 2014 Lugano classification as determined by the investigator. Overall response rate was the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as achieving each of the following: Complete metabolic response. Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology). PR was defined as achieving each of the following: Partial metabolic response (findings indicate residual disease). Partial remission (>50% decrease in target measurable nodes, regression/ absence/ no increase of non-measured lesions, spleen regressed by >50% in length and no new lesions).
Time Frame	Up to 1.5 years

Outcome Measure Data

Analysis Population Description

Efficacy analysis set - All participants who received at least one dose of study drug, had valid baseline disease assessment(s) and at least one valid post-baseline disease assessment. Participants who did not have a post-baseline assessment due to early clinical progression or death (after receiving study drug) were also included. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	2	7	0
Number (95% Confidence Interval) [percentage of participants]	33.3 1110%	100 3333.3%	71.4 1020%

6. Secondary Outcome

Title	Duration of Response (DOR)
Description	DOR was defined as the time from the documentation of first tumor response (CR or PR) to disease progression or death. CR was defined as achieving each of the following: Complete metabolic response. Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology). PR was defined as achieving each of the following: Partial metabolic response (findings indicate residual disease). Partial remission (>50% decrease in target measurable nodes, regression/ absence/ no increase of non-measured lesions, spleen regressed by >50% in length and no new lesions).
Time Frame	Up to 1.5 years

Outcome Measure Data

Analysis Population Description

Efficacy analysis set - All participants who received at least one dose of study drug, had valid baseline disease assessment(s) and at least one valid post-baseline disease assessment. Participants who did not have a post-baseline assessment due to early clinical progression or death (after receiving study drug) were also included. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	3	7	0
Mean (Standard Deviation) [months]	NA (NA)	NA (NA)	NA (NA)

7. Secondary Outcome

Title	Complete Response Rate (CRR)
Description	CRR was defined as the percentage of participants with a BOR of CR, according to the 2014 Lugano classification, as determined by the investigator. CR was defined as achieving each of the following: Complete metabolic response. Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).
Time Frame	Up to 1.5 years

Outcome Measure Data

Analysis Population Description

Efficacy analysis set - All participants who received at least one dose of study drug, had valid baseline disease assessment(s) and at least one valid post-baseline disease assessment. Participants who did not have a post-baseline assessment due to early clinical progression or death (after receiving study drug) were also included. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	2	7	0
Number (95% Confidence Interval) [percentage of participants]	0 0%	50 1666.7%	0 0%

8. Secondary Outcome

Title	Relapse-free Survival (RFS)
Description	RFS was defined as the time from the documentation of CR to disease progression or death. CR was defined as achieving each of the following: Complete metabolic response. Complete radiologic response (target node regress to <1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology). Disease progression was defined as progressive metabolic disease and one of the following: Target node progression. An individual extranodal lesion must be abnormal with length > 1.5cm and/or increase of length > 50%. New or clear progression of non-measured lesions. Regrowth of previously resolved lesions or new nodes >1.5 cm in length. New or recurrent bone marrow involvement.
Time Frame	Up to 1.5 years

Outcome Measure Data

Analysis Population Description

Efficacy analysis set - All participants who received at least one dose of study drug, had valid baseline disease assessment(s) and at least one valid post-baseline disease assessment. Participants who did not have a post-baseline assessment due to early clinical progression or death (after receiving study drug) were also included. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	2	7	0
Mean (Standard Deviation) [months]	NA (NA)	NA (NA)	NA (NA)

9. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	PFS was defined as the time between start of treatment and the first documentation of progression, or death. Disease progression was defined as progressive metabolic disease and one of the following: Target node progression. An individual extranodal lesion must be abnormal with length > 1.5cm and/or increase of length > 50%. New or clear progression of non-measured lesions. Regrowth of previously resolved lesions or new nodes >1.5 cm in length. New or recurrent bone marrow involvement.
Time Frame	Up to 1.5 years

Outcome Measure Data

Analysis Population Description

Efficacy analysis set - All participants who received at least one dose of study drug, had valid baseline disease assessment(s) and at least one valid post-baseline disease assessment. Participants who did not have a post-baseline assessment due to early clinical progression or death (after receiving study drug) were also included. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	2	7	0
Mean (Standard Deviation) [months]	NA (NA)	NA (NA)	NA (NA)

10. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was defined as the time between the start of treatment and death from any cause.
Time Frame	Up to 1.5 years

Outcome Measure Data

Analysis Population Description

Efficacy analysis set - All participants who received at least one dose of study drug, had valid baseline disease assessment(s) and at least one valid post-baseline disease assessment. Participants who did not have a post-baseline assessment due to early clinical progression or death (after receiving study drug) were also included. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	2	7	0
Mean (Standard Deviation) [months]	NA (NA)	NA (NA)	NA (NA)

11. Secondary Outcome

Title	Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Description	Cmax of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. Cmax of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.
Time Frame	Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Outcome Measure Data

Analysis Population Description

Pharmacokinetics (PK) population - All participants with at least one pre- Cycle 1 Day 1 (C1D1) and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	3	7	0
Cycle 1 - Conjugated Antibody	540 (52.4)	1683 (22.6)	1980 (30.6)
Cycle 1 - Total Antibody	1001 (51.6)	3122 (16.7)	2966 (25.4)
Cycle 1 - SG3199	0.0350 (58.5)
Cycle 2 - Conjugated Antibody	621 (48.7)	1946 (33.5)	1582 (31.7)
Cycle 2 - Total Antibody	1228 (44.6)	3510 (23.9)	2899 (29.3)

12. Secondary Outcome

Title	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Description	AUC0-last of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. AUC0-last of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.
Time Frame	Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Outcome Measure Data

Analysis Population Description

PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	3	7	0
Cycle 1 - Conjugated Antibody	4265 (52.5)	17217 (32.7)	5763 (253)
Cycle 1 - Total Antibody	7603 (35.0)	29456 (34.3)	3682 (917)
Cycle 1 - SG3199	0.00300 (61.9)
Cycle 2 - Conjugated Antibody	5305 (24.9)	5390 (1410)	7588 (61.7)
Cycle 2 - Total Antibody	10388 (21.1)	9122 (1485)	13264 (67.9)

13. Secondary Outcome

Title	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Description	AUCinf of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. AUCinf of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.
Time Frame	Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Outcome Measure Data

Analysis Population Description

PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	2	2	2	0
Cycle 1 - Total Antibody	15954 (NA)
Cycle 2 - Conjugated Antibody	5461 (64.5)	18182 (15.3)	8504 (41.4)
Cycle 2 - Total Antibody	7710 (NA)	27875 (NA)	15382 (54.0)

14. Secondary Outcome

Title	Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Description	Thalf of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2. Thalf of warhead SG3199 was only calculated for Cycle 1 as data was not collected for Cycle 2.
Time Frame	Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Outcome Measure Data

Analysis Population Description

PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	2	2	2	0
Cycle 1 - Total Antibody	8.13 (NA)
Cycle 2 - Conjugated Antibody	8.84 (33.6)	16.9 (54.9)	5.93 (213)
Cycle 2 - Total Antibody	15.1 (NA)	33.9 (NA)	6.28 (180)

15. Secondary Outcome

Title	Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Description	CL for Cycle 2 reflects steady-state clearance. CL of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2.
Time Frame	Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Outcome Measure Data

Analysis Population Description

PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	2	2	2	0
Cycle 1 - Total Antibody	0.846 (NA)
Cycle 2 - Conjugated Antibody	0.927 (50.7)	0.319 (6.31)	1.33 (36.4)
Cycle 2 - Total Antibody	0.720 (NA)	0.212 (NA)	0.872 (NA)

16. Secondary Outcome

Title	Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Description	Vss of loncastuximab tesirine conjugated antibody and total antibody was calculated for Cycles 1 and 2.
Time Frame	Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Outcome Measure Data

Analysis Population Description

PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	2	2	2	0
Cycle 1 - Total Antibody	9.39 (NA)
Cycle 2 - Conjugated Antibody	11.3 (94.4)	7.36 (38.7)	6.95 (270)
Cycle 2 - Total Antibody	13.7 (NA)	8.61 (NA)	5.14 (171)

17. Secondary Outcome

Title	Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody and Total Antibody
Description	AI is the ratio of drug accumulation after repeated administration compared to a single dose. AI of loncastuximab tesirine conjugated antibody and total antibody was calculated from Cycles 1 and 2.
Time Frame	Cycles 1 and 2 (where Cycle 1 was 4 weeks long and Cycle 2 was 6 weeks long): Day 1 pre-dose and at 0.5 and 4 hours post-dose, Day 8 and Day 15

Outcome Measure Data

Analysis Population Description

PK population - All participants with at least one pre- C1D1 and one post-dose valid assessment. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	2	2	2	0
Cycle 2 - Conjugated Antibody	1.25 (12.9)	1.77 (33.0)	1.27 (34.4)
Cycle 2 - Total Antibody	1.62 (NA)	2.87 (NA)	1.26 (33.3)

18. Secondary Outcome

Title	Number of Participants With an Anti-drug Antibody (ADA) Response to Loncastuximab Tesirine
Description	Detection of ADAs were performed by using a screening assay for identification of antibody positive samples/patients, a confirmation assay, and titer assessment, and were performed using the Meso-Scale Discovery Electrochemiluminescence platform.
Time Frame	Cycle 1 (= 3 weeks): Day 1 pre-dose & Day 15; Cycles 2, 3, 5, 6, & 7 (Cycle 2 = 6 weeks, other cycles = 4 weeks): Day 1 pre-dose; 30 days after last dose of study drugs

Outcome Measure Data

Analysis Population Description

Safety analysis set - All participants who received the study drug. The study was terminated prior to initiation of the dose expansion, so results are only presented for the dose escalation.

Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg	Dose Escalation: Loncastuximab Tesirine 120 μg/kg	Dose Escalation: Loncastuximab Tesirine 150 μg/kg	Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.	The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
Measure Participants	3	3	7	0
Count of Participants [Participants]	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Day 1 up to end of follow-up (maximum duration was 1.5 years)
Adverse Event Reporting Description	TEAEs collected up to 30 days after last dose of study drug or initiation of new anti-cancer therapy. The only AEs collected beyond that were treatment related SAEs and ACM for up to 1.5 years
Arm/Group Title	Dose Escalation: Loncastuximab Tesirine 90 μg/kg		Dose Escalation: Loncastuximab Tesirine 120 μg/kg		Dose Escalation: Loncastuximab Tesirine 150 μg/kg		Dose Expansion: Loncastuximab Tesirine
Arm/Group Description	Participants received loncastuximab tesirine as an intravenous (IV) infusion at a dose of 90 micrograms per kilogram (μg/kg) every 3 weeks (Q3W) on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a partial response (PR) or stable disease (SD) at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 milligrams (mg) on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.		Participants received loncastuximab tesirine as an IV infusion at a dose of 120 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.		Participants received loncastuximab tesirine as an IV infusion at a dose of 150 μg/kg Q3W on Day 1 of Cycles 1 and 2. Cycle 1 was 3 weeks long and Cycle 2 was 6 weeks long. Participants with a PR or SD at Week 15 received an additional 2 doses of loncastuximab tesirine on Day 8 of Cycles 5 and 6. All cycles other than Cycles 1 and 2 were 4 weeks long. Participants also received durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles.		The dose expansion phase was planned to consist of participants with diffuse large B-cell lymphoma, participants with mantle cell lymphoma and participants with follicular lymphoma. Participants were planned to receive loncastuximab tesirine as an IV infusion at the maximum tolerated dose (MTD) determined in the dose escalation part and durvalumab as an IV infusion at a dose of 1500 mg on Day 8 of Cycle 1 and Day 15 of Cycle 2, then on Day 1 of subsequent cycles. The study was terminated during the dose escalation part of the study and the dose expansion part was not initiated.
All Cause Mortality
	Dose Escalation: Loncastuximab Tesirine 90 μg/kg		Dose Escalation: Loncastuximab Tesirine 120 μg/kg		Dose Escalation: Loncastuximab Tesirine 150 μg/kg		Dose Expansion: Loncastuximab Tesirine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)		1/3 (33.3%)		0/7 (0%)		0/0 (NaN)
Serious Adverse Events
	Dose Escalation: Loncastuximab Tesirine 90 μg/kg		Dose Escalation: Loncastuximab Tesirine 120 μg/kg		Dose Escalation: Loncastuximab Tesirine 150 μg/kg		Dose Expansion: Loncastuximab Tesirine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)		2/3 (66.7%)		1/7 (14.3%)		0/0 (NaN)
Gastrointestinal disorders
Abdominal Pain	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
General disorders
Systemic inflammatory response syndrome	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Investigations
Blood lactic acid increased	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Metabolism and nutrition disorders
Dehydration	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Musculoskeletal and connective tissue disorders
Myositis	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Renal and urinary disorders
Acute kidney injury	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Urinary tract obstruction	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Other (Not Including Serious) Adverse Events
	Dose Escalation: Loncastuximab Tesirine 90 μg/kg		Dose Escalation: Loncastuximab Tesirine 120 μg/kg		Dose Escalation: Loncastuximab Tesirine 150 μg/kg		Dose Expansion: Loncastuximab Tesirine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		3/3 (100%)		7/7 (100%)		0/0 (NaN)
Blood and lymphatic system disorders
Neutropenia	0/3 (0%)	0	1/3 (33.3%)	2	2/7 (28.6%)	2	0/0 (NaN)	0
Thrombocytopenia	0/3 (0%)	0	1/3 (33.3%)	1	2/7 (28.6%)	2	0/0 (NaN)	0
Anaemia	0/3 (0%)	0	1/3 (33.3%)	1	1/7 (14.3%)	1	0/0 (NaN)	0
Lymphopenia	0/3 (0%)	0	0/3 (0%)	0	2/7 (28.6%)	2	0/0 (NaN)	0
Leukopenia	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Cardiac disorders
Atrial fibrillation	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Ear and labyrinth disorders
Hypoacusis	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Gastrointestinal disorders
Abdominal pain	1/3 (33.3%)	2	1/3 (33.3%)	1	2/7 (28.6%)	2	0/0 (NaN)	0
Diarrhoea	1/3 (33.3%)	10	1/3 (33.3%)	2	0/7 (0%)	0	0/0 (NaN)	0
Abdominal distension	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Abdominal pain upper	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Constipation	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Flatulence	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Lip oedema	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Nausea	1/3 (33.3%)	4	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Oedema mouth	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Oral discomfort	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Oral disorder	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Stomatitis	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Vomiting	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
General disorders
Asthenia	0/3 (0%)	0	2/3 (66.7%)	2	1/7 (14.3%)	2	0/0 (NaN)	0
Fatigue	1/3 (33.3%)	1	1/3 (33.3%)	1	1/7 (14.3%)	1	0/0 (NaN)	0
Non-cardiac chest pain	1/3 (33.3%)	1	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Oedema peripheral	0/3 (0%)	0	1/3 (33.3%)	2	0/7 (0%)	0	0/0 (NaN)	0
Peripheral swelling	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Infections and infestations
Influenza	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Upper respiratory tract infection	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Investigations
Aspartate aminotransferase increased	1/3 (33.3%)	1	0/3 (0%)	0	3/7 (42.9%)	3	0/0 (NaN)	0
Alanine aminotransferase increased	0/3 (0%)	0	0/3 (0%)	0	3/7 (42.9%)	3	0/0 (NaN)	0
Blood alkaline phosphatase increased	0/3 (0%)	0	0/3 (0%)	0	3/7 (42.9%)	3	0/0 (NaN)	0
Gamma-glutamyltransferase increased	0/3 (0%)	0	0/3 (0%)	0	3/7 (42.9%)	3	0/0 (NaN)	0
Lymphocyte count decreased	2/3 (66.7%)	2	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Blood creatine phosphokinase increased	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Metabolism and nutrition disorders
Decreased appetite	1/3 (33.3%)	1	1/3 (33.3%)	1	1/7 (14.3%)	1	0/0 (NaN)	0
Hypokalaemia	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Hypomagnesaemia	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Hypophosphataemia	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Musculoskeletal and connective tissue disorders
Arthralgia	1/3 (33.3%)	1	1/3 (33.3%)	1	1/7 (14.3%)	1	0/0 (NaN)	0
Arthritis	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Musculoskeletal chest pain	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Myalgia	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Myositis	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Neck pain	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Pain in extremity	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Nervous system disorders
Headache	1/3 (33.3%)	3	0/3 (0%)	0	2/7 (28.6%)	2	0/0 (NaN)	0
Taste disorder	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Renal and urinary disorders
Acute kidney injury	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Respiratory, thoracic and mediastinal disorders
Cough	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Dyspnoea	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Skin and subcutaneous tissue disorders
Pruritus	1/3 (33.3%)	2	0/3 (0%)	0	2/7 (28.6%)	2	0/0 (NaN)	0
Rash	1/3 (33.3%)	1	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Rash maculo-papular	0/3 (0%)	0	1/3 (33.3%)	1	1/7 (14.3%)	1	0/0 (NaN)	0
Blister	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Decubitus ulcer	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Dermatitis acneiform	1/3 (33.3%)	2	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Dry skin	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Erythema	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Hyperhidrosis	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	2	0/0 (NaN)	0
Night sweats	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Photosensitivity reaction	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Vascular disorders
Deep vein thrombosis	1/3 (33.3%)	1	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0
Flushing	0/3 (0%)	0	0/3 (0%)	0	1/7 (14.3%)	1	0/0 (NaN)	0
Hot flush	1/3 (33.3%)	1	0/3 (0%)	0	0/7 (0%)	0	0/0 (NaN)	0
Hypertension	0/3 (0%)	0	1/3 (33.3%)	1	0/7 (0%)	0	0/0 (NaN)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.