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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
COM902 monotherapy dose escalation. 		Monotherapy 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.
  • Drug: Dose escalation: COM902 monotherapy.
    COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.
Experimental
Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE). 		COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.
  • Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)
    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.
Experimental
COM902 monotherapy cohort expansion at RDFE. 		COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
  • Drug: Cohort expansion: COM902 (RDFE) monotherapy.
    COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
Experimental
COM902 + COM701 combination cohort expansion both at RDFE. 		COM902 + 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.
  • Drug: Cohort expansion: COM902 in combination with COM701 (both at the RDFE).
    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.
Experimental
MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab). 		Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks.
  • Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.
    Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.
Experimental
Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab). 		Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks.
  • Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.
    Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.

Recruiting Locations

Massachusetts General Hospital.
Boston, Massachusetts 02114
Contact:
COM902 Study Director
415-373-0781
COM902-001@cgen.com

More Details

Status
Recruiting
Sponsor
Compugen Ltd

Study Contact

Lead COM902 ClinInfo
‪+1 415 373 0781
COM902-001@cgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.