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New treatment option for Neoplasm
Official title A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT06759649
What this study is testing
What is COM503?
COM503 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Part 2 (dose expansion): Participants may be enrolled following disease progression that has progressed after at least 1 available standard therapy...
- Participants must have a solid tumor measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria...
You likely can't join if
- History of another malignancy within 2 years prior to the first trial intervention administration (unless the malignancy was treated with curative...
- Therapy with Immunosuppressive doses of systemic medications, such as steroids (doses \>10 mg/day prednisone or equivalent daily) within 2 weeks...
- 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...
- 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).
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Germantown, Tennessee, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Haifa, Israel, Israel
- Jerusalem, Israel, Israel
- Petah Tikva, Israel, Israel
- Ramat Gan, Israel, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States; Germantown, Tennessee, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.