NCT05608044

A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer

A Randomized, Open-Label, Phase 2 Study of Botensilimab (AGEN1181) as Monotherapy and in Combination With Balstilimab (AGEN2034) or Investigator's Choice Standard of Care (Regorafenib or Trifluridine and Tipiracil) for the Treatment of Refractory Metastatic Colorectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Agenus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer.

Detailed description

This study will enroll adult participants with a confirmed diagnosis of unresectable metastatic colorectal adenocarcinoma (CRC) who have had prior chemotherapy for metastatic or recurrent CRC. This study will consist of 5 cohorts. In the first and second cohorts, participants will receive 1 of 2 different doses of botensilimab intravenously (IV) and balstilimab IV. In the third and fourth cohorts, participants will receive 1 of 2 different doses of botensilimab. In the fifth cohort, participants will receive standard of care consisting of the investigator's choice of regorafenib or trifluridine and tipiracil.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Botensilimab	An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.
DRUG	Balstilimab	An anti-programmed death (ligand) 1 \[PD-(L)1\] monoclonal antibody.
DRUG	Standard of Care	Regorafenib or trifluridine and tipiracil.

Timeline

• Start date: 2022-11-30
• Primary completion: 2027-09-01
• Completion: 2029-09-01
• First posted: 2022-11-08
• Last updated: 2025-09-04

Locations

65 sites across 8 countries: United States, Belgium, Brazil, France, Georgia, Italy, Russia, Spain

Regulatory

• FDA-regulated drug study