A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Compugen Ltd
Study ID
NCT06759649
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cancer, Malignant Tumors
  • Neoplasm

Eligibility Criteria

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

Interventions

  • COM503 — DRUG
    Intravenous Infusion
  • Zimberelimab — DRUG
    Intravenous infusion

Study Details

The overall goal of this first-in-human (FIH) clinical trial is to learn about the safety and dosing of COM503 when given alone or in combination with zimberelimab in participants with advanced solid tumors. The primary objectives of this study are: * To assess the safety and tolerability of COM503 as monotherapy and COM503 in combination with zimberelimab in participants with advanced solid tumors. * To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and/or the recommended phase 2 dose (RP2D) of COM503 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.

Key Dates

Start date
Jan 7, 2025
Status verified
Sep 2025
Primary completion
Nov 22, 2027
Completion
Nov 22, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1, A-1
    Monotherapy Dose Escalation
  • Experimental: Part 1, A-2
    Backfill
  • Experimental: Part 1, B
    Dose escalation, COM503 in combination with a fixed dose of zimberelimab.
  • Experimental: Part 2, A
    Dose expansion, COM503 monotherapy
  • Experimental: Part 2, B
    Dose expansion, COM503 in combination with a fixed dose of zimberelimab.

Primary Outcome Measure

To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies. [ Time Frame: from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy. ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Yale- New Haven Hospital- Yale Cancer CenterNew HavenConnecticut06510
Study Coordinator
[email protected]
2038154124
Beth Israel Deaconess Medical CenterBostonMassachusetts0221502215
START MidwestGrand RapidsMichigan49546
Manish Sharma
[email protected]
6169545554
The West Clinic, PLCC dba West Cancer CenterGermantownTennessee38138
Manager of Phase 1 Research
[email protected]
9016830055
NEXT Oncology San AntonioSan AntonioTexas78229
David Sommerhalder
[email protected]
2105809500
STARTSan AntonioTexas78229
Drew Rasco
[email protected]
2105935250
NEXT Oncology VirginiaFairfaxVirginia22031
Mohammed Salkeni
[email protected]
7037834510

Find similar trials in New Haven, CT

By research site
Yale- New Haven Hospital- Yale Cancer Center· New Haven, CTBeth Israel Deaconess Medical Center· Boston, MASTART Midwest· Grand Rapids, MIThe West Clinic, PLCC dba West Cancer Center· Germantown, TNNEXT Oncology San Antonio· San Antonio, TXSTART· San Antonio, TX

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