COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Compugen Ltd
Study ID
NCT04354246
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dose escalation: COM902 monotherapy. — DRUG
    COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.
  • Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE) — COMBINATION_PRODUCT
    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.
  • Cohort expansion: COM902 (RDFE) monotherapy. — DRUG
    COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
  • Cohort expansion: COM902 in combination with COM701 (both at the RDFE). — DRUG
    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.
  • Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab. — COMBINATION_PRODUCT
    Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.

Study Details

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 Dates

Start date
Mar 31, 2020
Status verified
May 2026
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
94 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

The safety and tolerability of COM902 monotherapy and in combination with COM701. [ Time Frame: DLT evaluation window in the 1st cycle (21 Days). ]

Locations (9)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsSarasotaFlorida34230-
Massachusetts General Hospital.BostonMassachusetts02114-
START Midwest.Grand RapidsMichigan49503-
The Ohio State University Comprehensive Cancer Center.ColumbusOhio43210-
The University of Tennessee WEST Cancer Center.MemphisTennessee38138-
Mary Crowley Cancer ResearchDallasTexas75230-
MD Anderson Cancer Center.HoustonTexas77030-
The START Center for Cancer Care.San AntonioTexas78229-
Froedtert & Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Sarasota, FL

By condition
Colorectal cancerHead and neck cancerLung cancerMultiple myelomaOvarian cancer
By specialty
OncologyGI oncologyENTLung oncologyLung diseaseBlood cancerGynecologic oncologyWomen's health
By research site
Florida Cancer Specialists· Sarasota, FLMassachusetts General Hospital.· Boston, MASTART Midwest.· Grand Rapids, MIThe Ohio State University Comprehensive Cancer Center.· Columbus, OHThe University of Tennessee WEST Cancer Center.· Memphis, TNMary Crowley Cancer Research· Dallas, TX

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