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NCT05608044 · ClinicalTrials.gov registry record · Phase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
A Phase 2 study of Metastatic Colorectal Cancer, sponsored by Agenus.
- Active
- Registry status
- Phase 2
- Development phase
- 234
- Enrollment target
- 20
- Study locations
NCT05608044: Active Phase 2 study of Metastatic Colorectal Cancer, sponsored by Agenus.
NCT05608044 is a Phase 2 study of Metastatic Colorectal Cancer that is active but no longer recruiting, run by Agenus. The registered enrollment target is 234 participants, above the 181-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05608044, a Phase 2 study of Metastatic Colorectal Cancer, is active but no longer recruiting, sponsored by Agenus.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 234 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Objective response rate is defined as the proportion of participants with complete response or partial response, as assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Conditions Studied
Interventions
- DRUG Standard of Care
- DRUG Balstilimab
- DRUG Botensilimab
Study Locations (20)
New York
- Weill Cornell Medicine - New York
- Mount Sinai Hospital - New York - New York
- Memorial Sloan Kettering - New York
California
- City of Hope National Medical Center - Duarte
- Keck School of Medicine of the University of Southern California - Los Angeles
Colorado
- Rocky Mountain Cancer Center - Aurora - Aurora
- University of Colorado - Denver
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Oregon
- Earle A. Chiles Research Institute - Robert W. Franz Cancer Center - Providence Cancer Institute - Portland
- Oregon Health & Science University (OHSU) - Portland
Tennessee
- Tennessee Oncology Nashville (Sarah Cannon) - Nashville
- Vanderbilt University School of Medicine - Nashville
Arizona
- HonorHealth Research Institute - Scottsdale
Delaware
- Medical Oncology Hematology Consultants - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2022-11-30 |
| Est. Completion | 2029-09 |
| Phase | Phase 2 |
What the registry record for NCT05608044 still lists
NCT05608044 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, above the 181-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (29% higher).
The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.
NCT05608044 names 20 study sites across 13 states, led by New York, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05608044 about?
NCT05608044 is a clinical study titled "A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer". 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.
What is the current status of trial NCT05608044?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 234 participants. The study started on 2022-11-30. Estimated completion is 2029-09.
What conditions does trial NCT05608044 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer.
What interventions are being tested in trial NCT05608044?
The interventions under investigation include: Standard of Care (DRUG), Balstilimab (DRUG), Botensilimab (DRUG).
Who is sponsoring clinical trial NCT05608044?
This trial is sponsored by Agenus, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05608044 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05608044's enrollment target sits among peer trials
234 13th of 45 higher than 33 of 45 other Metastatic Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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