A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05608044
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 234 participants
Conditions and interventions
Conditions
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 30, 2022 (Actual)
- Primary completion
- Sep 2027 (Estimated)
- Completion
- Sep 2029 (Estimated)
- Last update posted
- Sep 4, 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 4, 2025 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05608044 live on ClinicalTrials.gov.