A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: COM503, Zimberelimab.
- Who it may be relevant to
- Registry conditions: Neoplasm, Cancer, Malignant Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug COM503
Intravenous Infusion - Drug Zimberelimab
Intravenous infusion
Primary outcome measures
- 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.]
- 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.]
- To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies [Time frame: 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.]
- To evaluate the safety profile of COM503 in combination with zimberelimab 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Yale- New Haven Hospital- Yale Cancer Center — New Haven
- Beth Israel Deaconess Medical Center — Boston
- START Midwest — Grand Rapids
- The West Clinic, PLCC dba West Cancer Center — Germantown
- NEXT Oncology San Antonio — San Antonio
- START — San Antonio
- NEXT Oncology Virginia — Fairfax
Israel · 4 centers
- Rambam Health Care Campus — Haifa
- Hadassah University Medical Center- Ein Kerem — Jerusalem
- Rabin Medical Center — Petah Tikva
- The Chaim Sheba Medical Center — Ramat Gan
Identifiers
NCT: NCT06759649 · CPG-05-101