A Clinical Trial to Assess COM503 in Participants with Advanced Solid Malignancies
Purpose
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.
Conditions
- Neoplasm
- Cancer, Malignant Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants with histologically/cytologically confirmed advanced recurrent or metastatic solid tumor malignancy - Part 1 (dose escalation): Participants must have had disease progression on or following all available standard of care (SOC) therapies known to confer clinical benefit. - Part 2 (dose expansion): Participants may be enrolled following disease progression that has progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized SOC. - Participants must have a solid tumor measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment
Exclusion Criteria
- History of another malignancy within 2 years prior to the first trial intervention administration (unless the malignancy was treated with curative intent with low risk of recurrence [e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar] which are allowed to enroll). - Therapy with Immunosuppressive doses of systemic medications, such as steroids (doses >10 mg/day prednisone or equivalent daily) within 2 weeks before trial intervention administration - Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD). - Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively. - Ascites or pleural effusion that is symptomatic and/or requiring drainage within 2 weeks prior to the first trial intervention administration. - Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or participants with human immunodeficiency virus (HIV). - Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the participant's participation in the trial.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
START Midwest
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
NEXT Oncology San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
NEXT Oncology Virginia
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- NCT ID
- NCT06759649
- Status
- Recruiting
- Sponsor
- Compugen Ltd