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

NCT05608044 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2025-09-04

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Agenus Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Agenus Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2027-09-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • France
  • Georgia
  • Italy
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608044 on ClinicalTrials.gov