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

Compugen

Status and phase: Enrolling; Phase 1

Conditions: Neoplasm; Cancer, Malignant Tumors

Treatments: Drug: COM503; Drug: Zimberelimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06759649

CPG-05-101

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 5 patient groups

Part 1, A-1

Experimental group

Description:

Monotherapy Dose Escalation

Treatment:

Drug: COM503

Part 1, A-2

Experimental group

Description:

Backfill

Treatment:

Drug: COM503

Part 1, B

Experimental group

Description:

Dose escalation, COM503 in combination with a fixed dose of zimberelimab.

Treatment:

Drug: Zimberelimab

Drug: COM503

Part 2, A

Experimental group

Description:

Dose expansion, COM503 monotherapy

Treatment:

Drug: COM503

Part 2, B

Experimental group

Description:

Dose expansion, COM503 in combination with a fixed dose of zimberelimab.

Treatment:

Drug: Zimberelimab

Drug: COM503