PK,PD,Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Patients With Relapsed/Refractory Diffuse Large B Cell Non-Hodgkin's Lymphoma

• Sponsor: Molecular Templates, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03488251
• Collaborator: (none)
• Enrollment: 8
• Locations: 9
• Arms: 4
• Actual Duration (Months): 30.7
• Patients Per Site: 0.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of MT-3724 in combination with gemcitabine and oxaliplatin (GEMOX) in participants with relapsed or refractory B-Cell NHL.

Condition or Disease	Intervention/Treatment	Phase
Non-hodgkin Lymphoma,B Cell; Refractory Diffuse Large B-Cell Lymphoma; Relapsed Diffuse Large B-Cell Lymphoma	Drug: MT-3724; Drug: Gemcitabine; Drug: Oxaliplatin	Phase 2

Detailed Description

This is a multi-center, open-label two-part study evaluating the safety and tolerability of MT-3724 in combination with GEMOX in relapsed or refractory B-cell Lymphoma patients.

Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 in combination with standard treatment of GEMOX

Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 from Part 1 in the MTD Expansion Cohort, where MT-3724 will be given at the MTD in combination with GEMOX. In addition, the PK, PD, immunogenicity and tumor response at the MTD of MT-3724 in combination with GEMOX will be more thoroughly evaluated in Part 2.

In original protocol and amendment 2, participants will be administered intravenous (IV) MT-3724 over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be administered Gemcitabine 1000 milligrams per meter square (mg/m^{2) as 30-minute IV infusion and Oxaliplatin 100 mg/m}2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be administered MT-3724 on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 will be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).

Continued Treatment with MT-3724 in combination with GEMOX will continue for four cycles of until death, disease progression, unacceptable toxicity, withdrawal of consent or another reason for withdrawal.

After four cycles, the participants who experience clinical benefit can continue MT-3724 treatment with additional cycles of 28 days each (either alone or in combination with GEMOX) if supported by the investigator's assessment of the benefit-risk ratio, after consultation with sponsor and Medical Monitor

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Subjects With Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma
• Actual Study Start Date: Aug 20, 2018
• Actual Primary Completion Date: Mar 12, 2021
• Actual Study Completion Date: Mar 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants will be administered intravenous (IV) MT-3724 10 micrograms per kilograms (mcg/kg) over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg will be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Drug: MT-3724; MT-3724 will be administered.; Drug: Gemcitabine; Gemcitabine will be administered.; Drug: Oxaliplatin; Oxaliplatin will be administered.
Experimental: Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants will be planned to administer IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be planned to administer Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be planned to administer MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg will be planned to administer weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be planned to administer on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Drug: MT-3724; MT-3724 will be administered.; Drug: Gemcitabine; Gemcitabine will be administered.; Drug: Oxaliplatin; Oxaliplatin will be administered.
Experimental: Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants will be planned to administer IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants will also be planned to administer Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants will be planned to administer MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg will be planned to administer weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be planned to administer on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Drug: MT-3724; MT-3724 will be administered.; Drug: Gemcitabine; Gemcitabine will be administered.; Drug: Oxaliplatin; Oxaliplatin will be administered.
Experimental: Part 2: MT-3724/ GEM/ OX Participants will be planned to administer Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).	Drug: MT-3724; MT-3724 will be administered.; Drug: Gemcitabine; Gemcitabine will be administered.; Drug: Oxaliplatin; Oxaliplatin will be administered.

Outcome Measures

Primary Outcome Measures

1. Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) [Up to 168 Days]

   A DLT is any treatment-emergent adverse event (TEAE) that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s).

2. Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Up to 168 Days]

   An AE is as any untoward medical occurrence in a participant or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental intervention(s). A SAE is any AE that is fatal or life-threatening, permanently disabling (incapacitating or interfering with the ability to resume usual life patterns), results in unplanned in-subject hospitalization or prolongation of an existing hospitalization, results in a congenital abnormality or birth defect, or any other situation that require medical or scientific judgement. Number of participants with common >=0 percent (%) TEAEs and SAEs are presented.

Secondary Outcome Measures

1. Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724 [Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)]

   Blood samples were planned to be collected at indicated time points for pharmacokinetic (PK) analysis of MT-3724. PK Population consisted of all participants who received at least one dose of MT-3724 and have at least one post-Baseline PK value.

2. Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724 [Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)]

   Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.

3. Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724 [Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)]

   Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.

4. Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range [Up to 168 Days]

   Blood samples were planned to be collected at indicated time points for analysis of immunophenotyping parameters which included cluster of differentiation (CD)3 (Percentage [%] and absolute), CD4 (% and absolute), CD8 (% and absolute), CD4:CD8 ratio, CD19 (% and absolute), Natural Killer (NK) cells (% and absolute), naïve B cells (% and absolute), non-switched memory B cells (% and absolute), class-switched memory B cells, Immunoglobulin (Ig)M only memory B cells (% and absolute), and total memory B cells (% and absolute).

5. Part 1 and 2: Number of Participants With Anti-drug Antibody Titer [Up to 168 Days]

   Blood samples were planned to be collected at indicated time points for analysis of anti-drug antibody titer.

6. Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies [Up to 168 Days]

   Blood samples were planned to be collected at indicated time points for analysis of positive neutralizing antibodies.

7. Part 1 and 2: Objective Response Rate [Up to 168 Days]

   Objective response rate is defined as the participants with a reduction in tumor size (Partial Response [PR] or Complete Response [CR]) using the Lugano Classification for Lymphoma, adjusted according to Lymphoma response to immunomodulatory therapy criteria (LYRIC).

8. Part 1 and 2: Disease Control Rate [Up to 168 Days]

   Disease Control rate is defined as participants with objective response of CR, PR or stable disease (SD) defined as SD for 3 months or longer from the Baseline scan.

9. Part 1 and 2: Duration of Response [Up to 168 Days]

   Duration of Response is defined as the time from first documented stable disease to the actual date of disease progression or death, for participants who met the criteria of having stable disease for at least 3 months from Baseline. Data was not collected due to early termination of the trial.

10. Part 1 and 2: Progression-free Survival [Up to 168 Days]

    Progression-Free Survival is defined as the time from the start of treatment with MT-3724 on Cycle 1 Day 1 to the date of disease progression or death from any cause. Data was not collected due to early termination of the trial.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Be adequately informed about the study and fully consent to participation as demonstrated by signing the written informed consent form before any screening procedure.

2. Be aged ≥18 years on the date of signing the informed consent form.

3. Have relapsed or refractory B-cell NHL that, in the investigator's opinion, could benefit from MT-3724+GEMOX therapy. At least one histologically documented relapse of

NHL, by:

1. Bone marrow biopsy (FNA is not acceptable) or

2. Excisional lymph node biopsy or

3. Core biopsy of any involved organ (FNA not acceptable)

4. CD20-positive histology must have been confirmed at any time during NHL disease course and documented in the medical history

5. If no histology is available after any relapse the investigator can consult the medical monitor to discuss if the patient can be included

6. All subtypes of B-cell NHL may be considered for Part 1 (MT-3724 dose escalation). Only histologically documented DLBCL (including mixed histology) may be considered for Part 2 (expansion cohort).

7. Have received all approved therapies for NHL that are applicable for the patient in the opinion of the treating physician.

8. Patients refractory to treatment are eligible.

9. Patient who have progressed following CAR T-cell therapy are also eligible.

10. Have measurable disease by Lugano Classification for NHL

11. 1.5 cm longest diameter (LDi) for lymph nodes

12. 1 cm LDi for extranodal disease

13. Have ECOG performance score of ≤2.

14. Have adequate bone marrow function, as determined by:

15. Absolute neutrophil count (ANC) ≥1,000/mm3 and

16. Platelet count ≥50,000 mm³

17. Have adequate kidney function, assessed by thecreatinine clearance (CLcr) to be ≥ 50 mL/min either measured or estimated using the Cockcroft-Gault formula. .

1. At the investigator's discretion,calculated estimated CLcr of < 50mL/min may be verified eGFR based on the 24-hour urine collection. Subjects with GFR ≥50 mL/min will be eligible irrespective of the estimated CLcr result.

1. Have adequate hepatic function, as determined by:

2. Total bilirubin ≤1.5 x ULN, or ≤3 x ULN for subjects with Gilbert's Syndrome and

3. Aspartate aminotransferase (AST) ≤3 x ULN (or ≤ 5.0 x ULN if liver involvement) and

4. Alanine aminotransferase (ALT) ≤3 x ULN (or ≤ 5.0 x ULN if liver involvement).

5. Have adequate coagulation, as determined by:

6. INR or PT ≤1.5 x ULN

7. aPTT ≤1.5 x ULN

8. Have adequate serum albumin, as determined by:

1. Albumin ≥ 3.0 g/dL

1. Women of reproductive potential must have a negative pregnancy test during the screening period within 72 hours before the start of treatment. Women not of reproductive potential are female subjects who are postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy,bilateral salpingectomy).

2. Subjects of reproductive potential and their partners must agree to either to abstain continuously from heterosexual intercourse or to use a reliable birth control method between signing the informed consent until 6 months following the last dose of MT-3724 or GEMOX . The investigator or a designated associate should advise the subject how to achieve adequate contraception. The following birth control methods may be considered as adequate

3. Condoms (male or female) with or without a spermicidal agent;

4. Diaphragm or cervical cap with spermicide;

5. Intrauterine device;

6. Hormone-based contraception: Established use of oral, injected, or implanted hormonal methods of contraception;

7. True abstinence;

8. Vasectomy is an acceptable method for a male subject or male partner of a female subject.

Exclusion criteria:

1. History or current evidence of neoplastic disease that is histologically distinct from NHL except cervical carcinoma in situ, superficial noninvasive bladder tumors, curatively treated Stage I-II non-melanoma skin cancer, or any other previous cancer curatively treated >2 years before the start of treatment.

2. Current evidence of new or growing brain or spinal metastases during screening.

3. History of allogeneic hematopoietic stem cell transplant within 180 days before the start of treatment.

4. Current evidence of acute or chronic Graft versus Host Disease.

5. Current evidence of CTCAE Grade >1 toxicity (except for hair loss, and those toxicities

6. Current evidence of incomplete recovery from surgery before the start of treatment, or planned surgery at any time during the study until the EoT Visit, except minor elective interventions deemed acceptable by the investigator.

7. History or current evidence of significant (CTCAE Grade ≥2) infection or wound within 4 weeks before the start of treatment.

8. Patients with uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to start of study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis may not be enrolled.

9. Patients with a known history of drug abuse or any chronic neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic or renal disease (including a history of hemolytic uremic syndrome) that in the opinion of the Investigator would adversely affect study participation.

10. Patients with known active Hepatitis C, HIV or a present history of Hepatitis B

11. Women who are pregnant or breastfeeding

12. History or current evidence of hypersensitivity to any study drugs, or current evidence of hypersensitivity requiring systemic steroid doses ≥20 mg/day Prednisone equivalent

13. Received any amount of anti-CD20 MAb therapy within the following periods before the start of treatment

14. Rituximab (Rituxan®): 84 days; if a subject had received rituximab within 37 Weeks before the start of treatment, then a serum rituximab level must be negative (<500 ng/mL) at the screening period

15. Obinutuzumab (Gazyva®): 184 days

16. Ofatumumab (Arzerra®): 88 days

17. Received therapy for NHL (except anti-CD20 Mab listed above) within 4 weeks before the start of treatment

18. Any investigational drug treatment from 4 weeks or 5 half-lives of the agent before the start of treatment, whichever is longer, until the EoT Visit

19. Received radiotherapy to tumor lesions that would be chosen as target lesions (measurable disease) within 4 weeks before the start of treatment, unless the lesion exhibited objective progression between the radiotherapy and the screening according to the Lugano Classification for NHL.

1. Palliative radiotherapy to non-target lesions is allowed at the investigator's discretion after consultation with the Medical Monitor and sponsor.

1. Received any vaccines within 28 days of the start of treatment, or likely to require vaccines at any time from the start of treatment until 28 days after the last dose of MT-3724. Injectable flu vaccine (inactivated or recombinant) is permitted at the investigator's discretion

2. Received systemic immune modulators within 2 weeks before the start of treatment including but not limited to systemic corticosteroids >20 mg/day of prednisone equivalent, cyclosporine and tacrolimus. Corticosteroids for pre-medication and NSAIDs are permitted.

3. Received any investigational drug treatment within 4 weeks or within 5 half-lives of the therapeutic agent before the start of treatment, whichever is longer, until EoT Visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Irvine Health / Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
2	Sarcoma Oncology	Santa Monica	California	United States	90403
3	Innovative Clinical Research Institute	Whittier	California	United States	90603
4	Rush University	Chicago	Illinois	United States	60612
5	Indiana Blood and Marrow Transplantation	Indianapolis	Indiana	United States	46237
6	University of Maryland Greenebaum Comprehensive Cancer Center	Baltimore	Maryland	United States	21201
7	Duke Cancer Center	Durham	North Carolina	United States	27710
8	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
9	UT Southwestern Medical Center Clinical Research	Dallas	Texas	United States	75390

Sponsors and Collaborators

• Molecular Templates, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 14, 2019
• Statistical Analysis Plan - Mar 25, 2021

More Information

Publications

None provided.

• Responsible Party: Molecular Templates, Inc.
• ClinicalTrials.gov Identifier: NCT03488251
• Other Study ID Numbers: MT-3724_NHL_002
• First Posted: Apr 4, 2018
• Last Update Posted: Aug 16, 2022
• Last Verified: Jul 1, 2022

• 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
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Gemcitabine; Oxaliplatin

Study Results

Participant Flow

Recruitment Details	This was a 2-part study [Part 1 (Dose Escalation) and Part 2 (Dose Expansion)], to investigate safety, tolerability, efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX) in participants with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma.
Pre-assignment Detail	A total of 8 participants were enrolled in the study. This study was terminated in Part 1 as the potential risks outweighed benefits; hence, Part 1 (Cohorts 2 and 3) and Part 2 were not conducted.

Arm/Group Title	Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 micrograms per kilograms (mcg/kg) over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Period Title: Part 1:Dose Escalation (Up to 168 Days)
STARTED	8	0	0	0
COMPLETED	0	0	0	0
NOT COMPLETED	8	0	0	0
Period Title: Part 1:Dose Escalation (Up to 168 Days)
STARTED	0	0	0	0
COMPLETED	0	0	0	0
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX	Total
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).	Total of all reporting groups
Overall Participants	8	0	0	0	8
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	70.8 (7.42)	70.8 (7.42)
Sex: Female, Male (Count of Participants)
Female	1 12.5%	1 Infinity
Male	7 87.5%	7 Infinity
Race/Ethnicity, Customized (Count of Participants)
Black or African American	1 12.5%	1 Infinity
White	6 75%	6 Infinity
Unknown	1 12.5%	1 Infinity

Outcome Measures

1. Primary Outcome

Title	Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
Description	A DLT is any treatment-emergent adverse event (TEAE) that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s).
Time Frame	Up to 168 Days

Outcome Measure Data

Analysis Population Description

Safety Population consisted of all participants who received at least 1 dose of any study drug (either MT-3724, or gemcitabine or oxaliplatin). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	8	0	0	0
Count of Participants [Participants]	2 25%

2. Primary Outcome

Title	Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description	An AE is as any untoward medical occurrence in a participant or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental intervention(s). A SAE is any AE that is fatal or life-threatening, permanently disabling (incapacitating or interfering with the ability to resume usual life patterns), results in unplanned in-subject hospitalization or prolongation of an existing hospitalization, results in a congenital abnormality or birth defect, or any other situation that require medical or scientific judgement. Number of participants with common >=0 percent (%) TEAEs and SAEs are presented.
Time Frame	Up to 168 Days

Outcome Measure Data

Analysis Population Description

Safety Population. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	8	0	0	0
TEAEs	8 100%
SAEs	4 50%

3. Secondary Outcome

Title	Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724
Description	Blood samples were planned to be collected at indicated time points for pharmacokinetic (PK) analysis of MT-3724. PK Population consisted of all participants who received at least one dose of MT-3724 and have at least one post-Baseline PK value.
Time Frame	Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)

Outcome Measure Data

Analysis Population Description

PK Population. Data was not calculated for Part 1: Cohort 1 due to high proportion of non-quantifiable values (>30% of values were imputed). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	8	0	0	0
Geometric Mean (Geometric Coefficient of Variation) [Micrograms per milliliter]	NA (NA)

4. Secondary Outcome

Title	Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724
Description	Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.
Time Frame	Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)

Outcome Measure Data

Analysis Population Description

PK Population. Data was not calculated for Part 1: Cohort 1 due to high proportion of non-quantifiable values (>30% of values were imputed). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	8	0	0	0
Geometric Mean (Geometric Coefficient of Variation) [Hours*micrograms per milliliter]	NA (NA)

5. Secondary Outcome

Title	Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724
Description	Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.
Time Frame	Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)

Outcome Measure Data

Analysis Population Description

PK Population. Data was not calculated for Part 1: Cohort 1 due to high proportion of non-quantifiable values (>30% of values were imputed). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	8	0	0	0
Median (Full Range) [Hours]	NA

6. Secondary Outcome

Title	Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range
Description	Blood samples were planned to be collected at indicated time points for analysis of immunophenotyping parameters which included cluster of differentiation (CD)3 (Percentage [%] and absolute), CD4 (% and absolute), CD8 (% and absolute), CD4:CD8 ratio, CD19 (% and absolute), Natural Killer (NK) cells (% and absolute), naïve B cells (% and absolute), non-switched memory B cells (% and absolute), class-switched memory B cells, Immunoglobulin (Ig)M only memory B cells (% and absolute), and total memory B cells (% and absolute).
Time Frame	Up to 168 Days

Outcome Measure Data

Analysis Population Description

Safety Population. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	8	0	0	0
Count of Participants [Participants]	NA NaN

7. Secondary Outcome

Title	Part 1 and 2: Number of Participants With Anti-drug Antibody Titer
Description	Blood samples were planned to be collected at indicated time points for analysis of anti-drug antibody titer.
Time Frame	Up to 168 Days

Outcome Measure Data

Analysis Population Description

Immunogenicity population: All participants who received at least one dose of MT-3724 and have at least one post-Baseline immunogenicity assessment. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	8	0	0	0
Count of Participants [Participants]	NA NaN

8. Secondary Outcome

Title	Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies
Description	Blood samples were planned to be collected at indicated time points for analysis of positive neutralizing antibodies.
Time Frame	Up to 168 Days

Outcome Measure Data

Analysis Population Description

Immunogenicity population. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	8	0	0	0
Count of Participants [Participants]	NA NaN

9. Secondary Outcome

Title	Part 1 and 2: Objective Response Rate
Description	Objective response rate is defined as the participants with a reduction in tumor size (Partial Response [PR] or Complete Response [CR]) using the Lugano Classification for Lymphoma, adjusted according to Lymphoma response to immunomodulatory therapy criteria (LYRIC).
Time Frame	Up to 168 Days

Outcome Measure Data

Analysis Population Description

Efficacy Population: All participants who received at least 1 dose of any study drug and have the Baseline tumor assessment as well as at least one post-Baseline tumor assessment. Only those participants with data available at the specified time points were analyzed. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	7	0	0	0
Count of Participants [Participants]	3 37.5%

10. Secondary Outcome

Title	Part 1 and 2: Disease Control Rate
Description	Disease Control rate is defined as participants with objective response of CR, PR or stable disease (SD) defined as SD for 3 months or longer from the Baseline scan.
Time Frame	Up to 168 Days

Outcome Measure Data

Analysis Population Description

Efficacy Population. Only those participants with data available at the specified time points were analyzed. Data could not be calculated for Part 1: Cohort 1 as no participants had a confirmed CR or PR. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	7	0	0	0
Count of Participants [Participants]	NA NaN

11. Secondary Outcome

Title	Part 1 and 2: Duration of Response
Description	Duration of Response is defined as the time from first documented stable disease to the actual date of disease progression or death, for participants who met the criteria of having stable disease for at least 3 months from Baseline. Data was not collected due to early termination of the trial.
Time Frame	Up to 168 Days

Outcome Measure Data

Analysis Population Description

Efficacy Population. Only those participants with data available at the specified time points were analyzed. Data could not be calculated for Part 1: Cohort 1 as no participants had a confirmed CR or PR. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	7	0	0	0
Median (Inter-Quartile Range) [Months]	NA

12. Secondary Outcome

Title	Part 1 and 2: Progression-free Survival
Description	Progression-Free Survival is defined as the time from the start of treatment with MT-3724 on Cycle 1 Day 1 to the date of disease progression or death from any cause. Data was not collected due to early termination of the trial.
Time Frame	Up to 168 Days

Outcome Measure Data

Analysis Population Description

Efficacy Population. Only those participants with data available at the specified time points were analyzed. Data could not be calculated for Part 1: Cohort 1 as no participants had a confirmed CR or PR. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX	Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Measure Participants	7	0	0	0
Median (Inter-Quartile Range) [Months]	NA

Adverse Events

Time Frame	All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1.
Adverse Event Reporting Description	Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.
Arm/Group Title	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX		Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX		Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX		Part 2: MT-3724/ GEM/ OX
Arm/Group Description	In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).		In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).		In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).		Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
All Cause Mortality
	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX		Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX		Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX		Part 2: MT-3724/ GEM/ OX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX		Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX		Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX		Part 2: MT-3724/ GEM/ OX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/8 (50%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Cardiac disorders
Atrial flutter	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Nervous system disorders
Chemotherapy induced neurotoxicity	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Vascular disorders
Capillary leak syndrome	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX		Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX		Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX		Part 2: MT-3724/ GEM/ OX
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/8 (100%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Blood and lymphatic system disorders
Anaemia	4/8 (50%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Thrombocytopenia	3/8 (37.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Neutropenia	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Leukopenia	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Cardiac disorders
Atrial flutter	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Palpitations	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Eye disorders
Periorbital oedema	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Gastrointestinal disorders
Nausea	7/8 (87.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Diarrhea	3/8 (37.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Abdominal pain	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Constipation	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Vomiting	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Abdominal distension	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Dyspepsia	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Gastric ulcer	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Gastritis	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hypoaesthesia oral	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
General disorders
Fatigue	5/8 (62.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Oedema peripheral	4/8 (50%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Chest pain	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Early satiety	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Impaired healing	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Injection site reaction	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Localised oedema	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Infections and infestations
Candida infection	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Influenza	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Oral herpes	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Rhinovirus infection	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Upper respiratory tract infection	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Injury, poisoning and procedural complications
Contusion	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Infusion related reaction	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Muscle strain	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Investigations
Neutrophil count decreased	4/8 (50%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Platelet count decreased	4/8 (50%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Aspartate aminotransferase increased	3/8 (37.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
White blood cell count decreased	3/8 (37.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Alanine aminotransferase increased	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Blood alkaline phosphatase increased	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Blood creatinine increased	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Lymphocyte count decreased	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Weight increased	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Blood creatine phosphokinase increased	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Metabolism and nutrition disorders
Hyponatraemia	4/8 (50%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased appetite	3/8 (37.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hypoalbuminaemia	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hypercalcaemia	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hyperglycaemia	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hypocalcaemia	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hypokalaemia	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hypophosphataemia	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Musculoskeletal and connective tissue disorders
Back pain	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Arthralgia	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Bone pain	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Muscle spasms	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Muscular weakness	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Myalgia	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Pain in extremity	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Nervous system disorders
Dysgeusia	5/8 (62.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Peripheral sensory neuropathy	5/8 (62.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Headache	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Paraesthesia	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Restless leg syndrome	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Burning sensation	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Dizziness	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Head discomfort	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Neuropathy peripheral	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Neurotoxicity	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Peripheral motor neuropathy	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Syncope	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Psychiatric disorders
Insomnia	3/8 (37.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Anxiety	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Libido increased	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Renal and urinary disorders
Pollakiuria	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Urinary tract infection	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Reproductive system and breast disorders
Erectile dysfunction	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Spontaneous penile erection	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Respiratory, thoracic and mediastinal disorders
Cough	3/8 (37.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Dyspnoea	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hiccups	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Oropharyngeal pain	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Rhinitis allergic	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Skin and subcutaneous tissue disorders
Pruritus	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Rash	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Alopecia	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Dermatitis acneiform	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Rash maculo-popular	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Urticaria	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Vascular disorders
Capillary leak syndrome	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hypotension	2/8 (25%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Flushing	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hypertension	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Orthostatic hypotension	1/8 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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