Botensilimab + Balstilimab for Colorectal Cancer

Recruiting in Cleveland (>99 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