Clinical trial NCT06759649: A Clinical Trial to Assess COM503 in Participants with Advanced Solid Malignancies
Official title: A First-in-Human, Phase 1 Dose Escalation and Dose Expansion Trial to Assess the Safety and Tolerability of COM503 As Monotherapy and in Combination Therapy in Participants with Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Neoplasm
Cancer, Malignant Tumors
Keywords: first-in-human
oncology
monoclonal antibody
immunotherapy
Lead sponsor: Compugen Ltd
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2025-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
timeFrame: 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.
measure: To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
timeFrame: 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.
measure: To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
timeFrame: from the first dose of COM503 in combination with zimberelimab to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
measure: To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: San Antonio
country: United States
facility: NEXT Oncology San Antonio
state: Texas
city: San Antonio
country: United States
facility: START
state: Texas
city: Fairfax
country: United States
facility: NEXT Oncology Virginia
state: Virginia
Study officials:
References: