Phase 2 Combat Trial: Botensilimab and Balstilimab for ctDNA-Positive Colorectal Adenocarcinoma, Apr 27 2026
Summary
A Phase II clinical trial (NCT07551596, titled 'Combat Trial') will evaluate botensilimab (AGEN1181) in combination with balstilimab (AGEN2034) for treating patients with stage II/III colorectal adenocarcinoma harboring detectable circulating tumor DNA (ctDNA). The immunotherapy regimen aims to eliminate residual microscopic cancer cells following standard treatment and uses ctDNA clearance as an early indicator of treatment response. The trial is registered with conditions including colorectal adenocarcinoma and stage-specific AJCC v8 classifications, with interventions comprising both study drugs plus biopsy, biospecimen collection, and radiographic examination procedures.
“Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread.”
About this source
ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.
What changed
A new Phase II clinical trial registration entry for NCT07551596 (Combat Trial) has been added to ClinicalTrials.gov. The trial will test the combination of botensilimab (AGEN1181) and balstilimab (AGEN2034) in patients with stage II/III colorectal adenocarcinoma who have detectable circulating tumor DNA in the blood.
Pharmaceutical companies developing immunooncology assets and clinical investigators running oncology trials should note this registration as it represents ongoing investment in ctDNA-guided adjuvant therapy approaches for colorectal cancer. The trial's use of ctDNA as both a patient-selection criterion and a potential response biomarker reflects an emerging clinical development strategy in early-stage oncology.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial
Phase 2 NCT07551596 Kind: PHASE2 Apr 27, 2026
Abstract
This phase II trial tests the effect of the botensilimab in combination with balstilimab in treating patients with stage II/III colorectal adenocarcinoma with detectable circulating tumor (ct) deoxyribonucleic acid (DNA) in the blood. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab may be an effective combination to remove any remaining microscopic cancer cells in the bloodstream in patients with stage II/III colorectal adenocarcinoma. In addition, clearing the ctDNA from the blood may serve as an early indicator of treatment response.
Conditions: Colorectal Adenocarcinoma, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
Interventions: Balstilimab, Biopsy Procedure, Biospecimen Collection, Botensilimab, Radiographic Examination
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.