COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies
1 other identifier
interventional
110
1 country
9
Brief Summary
Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2020
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2020
CompletedFirst Submitted
Initial submission to the registry
April 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedMay 22, 2025
May 1, 2025
5.8 years
April 15, 2020
May 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
The safety and tolerability of COM902 monotherapy and in combination with COM701.
Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).
DLT evaluation window in the 1st cycle (21 Days).
To identify the maximum tolerated dose (MTD) and/or recommended dose for expansion of COM902 monotherapy and in combination with COM701.
Evaluation of a dose of COM902 monotherapy and in combination with COM701 that is well tolerated by subjects.
18 months.
To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701.
Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration \[Cmax\]).
18 months.
Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Incidence of subjects on the Triplet combination (COM902 + COM701 + Pembrolizumab) with Adverse Events (AEs) per CTCAE v5.0.
18 months.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of PK parameters e.g., Cmax.
18 months.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of PK parameters e.g., AUC.
18 months.
Secondary Outcomes (2)
To characterize immunogenicity of COM902 monotherapy and in combination with COM701.
18 months.
To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).
18 months.
Other Outcomes (2)
Evaluation of the preliminary antitumor activity of COM902 as monotherapy and in combination with COM701.
24 months.
Preliminary antitumor activity of the triplet combination (COM902 + COM701 + Pembrolizumab).
24 months
Study Arms (6)
COM902 monotherapy dose escalation.
EXPERIMENTALMonotherapy dose escalation. COM902 monotherapy administered IV every 3 weeks in sequential dose escalation. Up to 7 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended dose for expansion (RDFE) is identified.
Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).
EXPERIMENTALCOM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.
COM902 monotherapy cohort expansion at RDFE.
EXPERIMENTALCOM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
COM902 + COM701 combination cohort expansion both at RDFE.
EXPERIMENTALCOM902 + COM701 (both at the RDFE) evaluated in subjects with select tumor types who have exhausted standard of care treatment: HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks.
MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab).
EXPERIMENTALTriplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks.
Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).
EXPERIMENTALTriplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks.
Interventions
COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.
Both study drugs will be evaluated at the RDFE for assessment of safety and tolerability. All study drugs will be administered IV every 3 weeks.
COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
COM902 in combination with COM701 (both at RDFE) in subjects with select tumor types who have exhausted standard treatment - HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks.
Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.
Eligibility Criteria
You may qualify if:
- Subjects with histologically/cytologically confirmed advanced malignancy (solid tumor) who must have exhausted all available standard therapy, or not a candidate for standard therapy.
- Subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- For Triplet combination MSS-CRC:
- Histologically confirmed adenocarcinoma of the colon/rectum
- Stage IV disease
- MSS-CRC status by an FDA approved test
- Disease progression with no more than 3 prior lines of treatment including fluroropyrimidines, irinotecan, and oxaliplatin
- For Triplet combination ovarian cancer:
- Advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
- Platinum resistant ovarian cancer (PROC) defined as disease recurrence \< 6 months after completion of a platinum-containing regimen: Patients with primary platinum refractory disease are ineligible. Primary platinum refractory disease is defined as progression of disease prior to completion of 1st line platinum therapy or immediately following (≤ 3 months following last date of chemotherapy)
- Received ≤3 prior lines for PROC; maintenance bevacizumab or PARP are not included as a line of therapy
- Subjects who have received PARP inhibitor therapy are eligible
You may not qualify if:
- Prior treatment with a TIGIT inhibitor.
- Prior treatment with an inhibitor of PVRIG
- Symptomatic interstitial lung disease or inflammatory pneumonitis.
- History of immune-related events that required immunotherapy treatment discontinuation
- For Triplet combination expansion cohorts (MSS-CRC and PROC): Prior treatment with an anti-PD-1/PD-L1/2, anti-CD96 antibody, anti-OX-40 antibody, anti-CD137 antibody, anti-LAG3, anti-TIM3, anti-CTLA4 antibody.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Compugen Ltdlead
Study Sites (9)
Florida Cancer Specialists
Sarasota, Florida, 34230, United States
Massachusetts General Hospital.
Boston, Massachusetts, 02114, United States
START Midwest.
Grand Rapids, Michigan, 49503, United States
The Ohio State University Comprehensive Cancer Center.
Columbus, Ohio, 43210, United States
The University of Tennessee WEST Cancer Center.
Memphis, Tennessee, 38138, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
MD Anderson Cancer Center.
Houston, Texas, 77030, United States
The START Center for Cancer Care.
San Antonio, Texas, 78229, United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
COM902 Study Director COM902 Study Director
Compugen Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2020
First Posted
April 21, 2020
Study Start
March 31, 2020
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share