Description:
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.
Title
- Brief Title: COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
- Official Title: A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies
Clinical Trial IDs
- ORG STUDY ID:
CPG-02-101
- NCT ID:
NCT04354246
Conditions
- Advanced Cancer
- Ovarian Cancer
- Lung Cancer
- Colon Cancer
- Plasma Cell Neoplasm
- Multiple Myeloma
- HNSCC
Interventions
Drug | Synonyms | Arms |
---|
Dose escalation: COM902 monotherapy. | | COM902 monotherapy dose escalation. |
Cohort expansion: COM902 (RDFE) monotherapy. | | COM902 monotherapy cohort expansion at RDFE. |
Cohort expansion: COM902 in combination with COM701 (both at the RDFE). | | COM902 + COM701 combination cohort expansion both at RDFE. |
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.
Trial Arms
Name | Type | Description | Interventions |
---|
COM902 monotherapy dose escalation. | Experimental | 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. | - Dose escalation: COM902 monotherapy.
|
Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE). | Experimental | COM902 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. | Experimental | COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks. | - Cohort expansion: COM902 (RDFE) monotherapy.
|
COM902 + COM701 combination cohort expansion both at RDFE. | Experimental | 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. | - Cohort expansion: COM902 in combination with COM701 (both at the RDFE).
|
Eligibility Criteria
Key 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.
Key Exclusion Criteria:
- Prior treatment with a TIGIT inhibitor.
- Symptomatic interstitial lung disease or inflammatory pneumonitis.
- History of immune-related events that required immunotherapy treatment
discontinuation.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | The safety and tolerability of COM902 monotherapy and in combination with COM701. |
Time Frame: | DLT evaluation window in the 1st cycle (21 Days). |
Safety Issue: | |
Description: | Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs). |
Secondary Outcome Measures
Measure: | To characterize immunogenicity of COM902 monotherapy and in combination with COM701. |
Time Frame: | 18 months. |
Safety Issue: | |
Description: | Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Compugen Ltd |
Last Updated
August 4, 2021