Trial NCT06759649
A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies
- Phase
- Phase 1
- Sponsor
- Compugen Ltd
- Conditions
- Neoplasm; Cancer, Malignant Tumors
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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).Prior malignancy
* 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).Brain metastases
* 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).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.
Restrictions found (3)
- Brain metastasesOutrightexclusionShow in the text
- HIVOutrightexclusionShow in the text
- Prior malignancyConditionalexclusion
within 2 years
Show in the text
Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Suffolk County