A Phase 1 interventional study of Dose escalation: COM902 monotherapy. and Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE) in Advanced Cancer, Ovarian Cancer and Lung Cancer, sponsored by Compugen Ltd. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Compugen Ltd · Phase 1, Interventional, and Treatment
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.
Key Inclusion Criteria:
For Triplet combination MSS-CRC:
For Triplet combination ovarian cancer:
Key Exclusion Criteria:
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.
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 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)
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 + 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).
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 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.
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.
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).
Time frame: 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.
Time frame: 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 \[Cmax\]).
Time frame: 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.
Time frame: 18 months.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of PK parameters e.g., Cmax.
Time frame: 18 months.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of PK parameters e.g., AUC.
Time frame: 18 months.
To characterize immunogenicity of COM902 monotherapy and in combination with COM701.
Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination.
Time frame: 18 months.
To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Evaluation of antidrug antibody to COM902, COM701.
Time frame: 18 months.
Evaluation of the preliminary antitumor activity of COM902 as monotherapy and in combination with COM701.
An assessment of preliminary antitumor activity eg ORR with COM902 monotherapy and COM902 in combination with COM701.
Time frame: 24 months.
Preliminary antitumor activity of the triplet combination (COM902 + COM701 + Pembrolizumab).
Assessment of preliminary antitumor activity e.g., ORR.
Time frame: 24 months
Plan to share: No
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Compugen Ltd