A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced Cancer
- Sponsor
- Compugen Ltd
- Enrollment
- 110
- Locations
- 9
- Primary Endpoint
- The safety and tolerability of COM902 monotherapy and in combination with COM701.
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
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-
- •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
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.
Outcomes
Primary Outcomes
The safety and tolerability of COM902 monotherapy and in combination with COM701.
Time Frame: DLT evaluation window in the 1st cycle (21 Days).
Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).
To identify the maximum tolerated dose (MTD) and/or recommended dose for expansion of COM902 monotherapy and in combination with COM701.
Time Frame: 18 months.
Evaluation of a dose of COM902 monotherapy and in combination with COM701 that is well tolerated by subjects.
Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Time Frame: 18 months.
Incidence of subjects on the Triplet combination (COM902 + COM701 + Pembrolizumab) with Adverse Events (AEs) per CTCAE v5.0.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).
Time Frame: 18 months.
Evaluation of PK parameters e.g., AUC.
To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701.
Time Frame: 18 months.
Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration \[Cmax\]).
Secondary Outcomes
- 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.)