COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.

Part of paid clinical trials in Los Angeles, California.

Sponsor
Compugen Ltd
Study ID
NCT03667716
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM701 as monotherapy and in combination with nivolumab.

Key Dates

Start date
Sep 6, 2018
Status verified
Jan 2025
Primary completion
Jan 30, 2024
Completion
Jan 30, 2024

Study Design

Enrollment
121 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: P1a Arm A (Monotherapy Dose Escalation).
    COM701 monotherapy sequential dose escalation administered IV every 3 weeks and a Cohort IV every 4 weeks. Up to 8 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended phase 2 dose is identified.
  • Experimental: P1a Arm B (Combination Dose Escalation).
    COM701 sequential dose escalation administered IV every 3 weeks in combination with Opdivo (Nivolumab) 360mg administered IV every 3 weeks and COM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480mg administered IV every 4 weeks.
  • Experimental: P1a Arm A (Monotherapy Expansion).
    COM701 monotherapy administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (NSCLC, Breast, Ovarian, Endometrial and Colorectal cancer).
  • Experimental: P1b (Combination Cohort Dose Expansion).
    COM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480 mg administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (Breast, Ovarian, Endometrial and Colorectal cancer).

Primary Outcome Measure

Incidence of subjects with Adverse Events (AEs) as per CTCAE v4.03 and Dose-Limiting Toxicities (DLTs). [ Time Frame: DLT evaluation window in the 1st cycle (21 or 28 days). ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of California Los Angeles (UCLA).Los AngelesCalifornia90095-
Florida Cancer SpecialistsSarasotaFlorida34230-
University of Chicago Medical CenterChicagoIllinois60637-
Massachusetts General HospitalBostonMassachusetts02114-
START Midwest.Grand RapidsMichigan49503-
Columbia UniversityNew YorkNew York10032-
Cleveland Clinic.ClevelandOhio44195-
The University of Tennessee WEST Cancer Center.MemphisTennessee38138-
Sarah Cannon Research Institute.NashvilleTennessee37203-
M D Anderson Cancer Center.HoustonTexas77030-
The START Center for Cancer Care.San AntonioTexas78229-

Find similar trials in Los Angeles, CA

By condition
Breast cancerEndometrial cancerLung cancerOvarian cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncologyLung oncologyLung disease
By research site
University of California Los Angeles (UCLA).· Los Angeles, CAFlorida Cancer Specialists· Sarasota, FLUniversity of Chicago Medical Center· Chicago, ILMassachusetts General Hospital· Boston, MASTART Midwest.· Grand Rapids, MIColumbia University· New York, NY

Related Studies