ClinicalTrials.gov record
Active, not recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT05608044

Public ClinicalTrials.gov record NCT05608044. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 8, 2026, 8:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT05608044
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Agenus Inc.
Industry
Enrollment
234 participants

Conditions and interventions

Interventions

  • Balstilimab Drug
  • Botensilimab Drug
  • Standard of Care Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 29, 2022
Primary completion
Aug 31, 2027
Completion
Aug 31, 2029
Last update posted
Sep 3, 2025

2022 – 2029

United States locations

U.S. sites
26
U.S. states
16
U.S. cities
21
Facility City State ZIP Site status
HonorHealth Research Institute Scottsdale Arizona 85258
City of Hope National Medical Center Duarte California 91010
Keck School of Medicine of the University of Southern California Los Angeles California 90033
Rocky Mountain Cancer Center - Aurora Aurora Colorado 80012
University of Colorado Denver Colorado 80220
Medical Oncology Hematology Consultants Newark Delaware 19713
Florida Cancer Specialists and Research Institute - Lake Mary Lake Mary Florida 32746
Beth Israel Deaconess Medical Center Boston Massachusetts 02215
Dana-Farber Cancer Institute Boston Massachusetts 02215
University of Michigan Ann Arbor Michigan 48084
Atlantic Health System - Morristown Medical Center Morristown New Jersey 07960
Weill Cornell Medicine New York New York 10021
Mount Sinai Hospital - New York New York New York 10029
Memorial Sloan Kettering New York New York 10065
Cleveland Clinic Cleveland Ohio 44195
Earle A. Chiles Research Institute - Robert W. Franz Cancer Center - Providence Cancer Institute Portland Oregon 97213
Oregon Health & Science University (OHSU) Portland Oregon 97239
Lifespan Clinical Research Center/Cancer Institute (Providence Rhode Island) East Providence Rhode Island 02915
Tennessee Oncology Nashville (Sarah Cannon) Nashville Tennessee 37203
Vanderbilt University School of Medicine Nashville Tennessee 37215
Texas Oncology - Austin Midtown Austin Texas 78705
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas 75246
MDACC Houston Texas 77030
Virginia Cancer Specialists/NEXT Virginia Fairfax Virginia 22031
Swedish Cancer Institute Seattle Washington 98104
Northwest Cancer Center Specialists - Vancouver Cancer Center - Compass Oncology Vancouver Vancouver Washington 98684

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05608044, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2025 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05608044 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →