Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04721015

Collaborator

(none)

109

Enrollment

Locations

Arms

69.1

Anticipated Duration (Months)

3.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed.

ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world.

In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28-day cycle.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors Cancer Non Small Cell Lung Cancer (NSCLC)	Drug: ABBV-637 Drug: Docetaxel Drug: Osimertinib	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

109 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors

Actual Study Start Date :

Feb 23, 2021

Anticipated Primary Completion Date :

Nov 28, 2026

Anticipated Study Completion Date :

Nov 28, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: ABBV-637 Monotherapy Participants will receive escalating doses of ABBV-637 in 28-day cycles.	Drug: ABBV-637 Intravenous (IV) Infusion
Experimental: Part 2a: ABBV-637 + Docetaxel Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles.	Drug: ABBV-637 Intravenous (IV) Infusion Drug: Docetaxel Intravenous (IV) Infusion
Experimental: Part 2b: ABBV-637 + Docetaxel Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles.	Drug: ABBV-637 Intravenous (IV) Infusion Drug: Docetaxel Intravenous (IV) Infusion
Experimental: Part 3a: ABBV-637 + Osimertinib Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles.	Drug: ABBV-637 Intravenous (IV) Infusion Drug: Osimertinib Oral Tablets
Experimental: Part 3b: ABBV-637 + Osimertinib Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles.	Drug: ABBV-637 Intravenous (IV) Infusion Drug: Osimertinib Oral Tablets

Outcome Measures

Primary Outcome Measures

Number of Participants Experiencing Adverse Events (AEs) [Up to approximately 3 years]
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3) [Up to approximately 3 years]
ORR is defined as the percentage of participants with a confirmed response (CR) or partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Secondary Outcome Measures

Percentage of Participants With Objective Response Rate (ORR) (Part 1) [Up to approximately 3 years]
ORR is defined as the percentage of participants with a confirmed response (CR) or partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1) [Up to approximately 12 months]
DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.
Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3) [Up to approximately 20 months]
DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.
Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3) [Up to approximately 20 months]
PFS is defined as the time from the first dose of any study drug to a documented radiographic disease progression according to RECIST version 1.1 as determined by the investigator, clinical progression or death from any cause, whichever occurs earlier.
Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3) [Up to approximately 12 months after last dose of study drug]
OS is defined as the time from the first dose of any study drug until death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologic solid tumor diagnosis (Part 1).
For Part 2 docetaxel combination therapy: EGFR WT expressing relapsed/refractory (R/R) non-small cell lung cancer (NSCLC) participants.
For Part 3 osimertinib combination therapy: mutEGFR-expressing RR NSCLC participants.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
For Part 1 only - history of R/R disease that has progressed on all standard of care therapy.
For Part 2 only - history of RR NSCLC that has progressed after treatment with platinum-based chemotherapy regimen and either immune checkpoint inhibitor or targeted therapy and may not have been treated with prior single agent chemotherapy.
For Part 3 only - history of RR NSCLC that has progressed on osimertinib
Meet the laboratory values as described in the protocol.

Exclusion Criteria:

History (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.
Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
For Part 3 only: History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AdventHealth Celebration /ID# 243020	Celebration	Florida	United States	34747-4970
2	Dana-Farber Cancer Institute /ID# 231209	Boston	Massachusetts	United States	02215
3	Washington University-School of Medicine /ID# 225698	Saint Louis	Missouri	United States	63110
4	Carolina BioOncology Institute /ID# 225358	Huntersville	North Carolina	United States	28078
5	Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145	Providence	Rhode Island	United States	02903-4923
6	South Texas Accelerated Research Therapeutics /ID# 225359	San Antonio	Texas	United States	78229
7	Virginia Cancer Specialists - Fairfax /ID# 225693	Fairfax	Virginia	United States	22031
8	Wollongong Hospital /ID# 228350	Wollongong	New South Wales	Australia	2500
9	Austin Health /ID# 225638	Heidelberg	Victoria	Australia	3084
10	AP-HM - Hopital de la Timone /ID# 225779	Marseille CEDEX 05	Bouches-du-Rhone	France	13385
11	Institut Bergonie /ID# 225778	Bordeaux	Gironde	France	33000
12	Institut Curie /ID# 225829	Paris CEDEX 05	Ile-de-France	France	75248
13	Centre Georges François Leclerc /ID# 226760	Dijon		France	21079
14	Institut Claudius Regaud /ID# 225780	Toulouse		France	31052
15	The Chaim Sheba Medical Center /ID# 225585	Ramat Gan	Tel-Aviv	Israel	5265601
16	Rambam Health Care Campus /ID# 225586	Haifa		Israel	3109601
17	NHO Nagoya Medical Center /ID# 244412	Nagoya-shi	Aichi	Japan	460-0001
18	National Cancer Center Hospital East /ID# 225725	Kashiwa-shi	Chiba	Japan	277-8577
19	National Hospital Organization Shikoku Cancer Center /ID# 240821	Matsuyama-shi	Ehime	Japan	791-0280
20	National Hospital Organization Kyushu Cancer Center /ID# 240761	Fukuoka-shi	Fukuoka	Japan	811-1395
21	National Cancer Center Hospital /ID# 225724	Chuo-ku	Tokyo	Japan	104-0045
22	National Cancer Center /ID# 231887	Goyang	Gyeonggido	Korea, Republic of	10408
23	Yonsei University Health System Severance Hospital /ID# 233774	Seoul	Seoul Teugbyeolsi	Korea, Republic of	03722
24	Asan Medical Center /ID# 231886	Seoul		Korea, Republic of	05505
25	Samsung Medical Center /ID# 231888	Seoul		Korea, Republic of	06351
26	Hospital Universitario Puerta de Hierro, Majadahonda /ID# 226096	Majadahonda	Madrid	Spain	28222
27	Hospital Universitario Vall d'Hebron /ID# 225976	Barcelona		Spain	08035
28	Hospital Universitario Fundacion Jimenez Diaz /ID# 225975	Madrid		Spain	28040
29	Hospital Universitario 12 de Octubre /ID# 225977	Madrid		Spain	28041
30	Hospital Universitario Virgen de la Victoria /ID# 225978	Malaga		Spain	29010
31	National Taiwan University Hospital - Hsinchu branch /ID# 243610	Hsinchu City		Taiwan	30059
32	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 243345	Kaohsiung		Taiwan	807
33	National Cheng Kung University Hospital /ID# 225944	Tainan		Taiwan	704
34	Linkou Chang Gung Memorial Hospital /ID# 225946	Taoyuan City		Taiwan	333