Botensilimab + Balstilimab for Colorectal Cancer
Recruiting in Palo Alto (17 mi)
+83 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Agenus Inc.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests botensilimab alone or with balstilimab in adults with advanced colorectal cancer who didn't respond to previous chemotherapy. The new drugs aim to enhance the immune system's ability to fight cancer.
Eligibility Criteria
This trial is for adults with metastatic colorectal cancer that's unremovable and has worsened after at least one chemotherapy regimen. They must have tried specific standard treatments, be in good physical condition (ECOG 0 or 1), and have a life expectancy of at least 12 weeks. Women should not be pregnant, and men must use contraception if their partners can bear children.Participant Groups
The study tests botensilimab alone or combined with balstilimab/standard care in patients with refractory metastatic colorectal cancer. It's an open-label Phase 2 trial to see how well these treatments work, how safe they are, what side effects occur, and how the body processes the drugs.
5Treatment groups
Experimental Treatment
Active Control
Group I: Monotherapy Botensilimab Dose 2Experimental Treatment1 Intervention
Participants will receive botensilimab dose 2 given IV.
Group II: Monotherapy Botensilimab Dose 1Experimental Treatment1 Intervention
Participants will receive botensilimab dose 1 given IV.
Group III: Combination Botensilimab Dose 2 plus BalstilimabExperimental Treatment2 Interventions
Participants will receive botensilimab at dose 2 given IV and balstilimab given IV.
Group IV: Combination Botensilimab Dose 1 plus BalstilimabExperimental Treatment2 Interventions
Participants will receive botensilimab at dose 1 given IV and balstilimab given IV.
Group V: Standard of CareActive Control1 Intervention
Participants will receive select standard of care as determined by the investigator.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Memorial Sloan KetteringNew York, NY
Florida Cancer Specialists and Research Institute - Lake MaryLake Mary, FL
Tennessee Oncology Nashville (Sarah Cannon)Nashville, TN
University of MichiganAnn Arbor, MI
More Trial Locations
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Who is running the clinical trial?
Agenus Inc.Lead Sponsor