BAL/BOT/agenT-797 Phase 2 Trial for pMMR Metastatic Colorectal Cancer With Liver Metastases
Summary
A Phase 2 clinical trial (NCT07550088) registered on April 24, 2026, is evaluating the combination of balstilimab (BAL), botensilimab (BOT), and agenT-797 in adults with previously treated metastatic colorectal cancer that is microsatellite stable (pMMR) and has spread to the liver. Participants will receive repeating 42-day treatment cycles and undergo imaging scans, blood biomarker collection, and tumor tissue sampling to assess tumor response and safety. The trial's primary endpoint is objective response rate; secondary endpoints include monitoring for immune-related and cytokine-related adverse events and overall survival.
“The goal of this clinical trial is to learn whether the combination of balstilimab, botensilimab, and agenT-797 is safe and effective in treating adults with previously treated metastatic colorectal cancer that is microsatellite stable (pMMR) and has spread to the liver.”
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 2 clinical trial registration (NCT07550088) was published on ClinicalTrials.gov for a triple-immunotherapy combination study in colorectal cancer. The trial evaluates balstilimab, botensilimab, and agenT-797 administered in repeating 42-day cycles for adults with previously treated metastatic pMMR colorectal cancer with liver metastases.
For sponsors and clinical investigators, this trial represents a novel combination approach in an underserved patient population (liver-metastatic MSS/pMMR CRC). The study includes standard efficacy endpoints (objective response rate via imaging) and safety endpoints (immune-related and cytokine-related adverse events), with required tumor tissue and blood sampling. Sites considering participation should verify IRB/ethics approval status and confirm availability of all three investigational products.
Archived snapshot
Apr 25, 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.
BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases
Phase 2 NCT07550088 Kind: PHASE2 Apr 24, 2026
Abstract
The goal of this clinical trial is to learn whether the combination of balstilimab, botensilimab, and agenT-797 is safe and effective in treating adults with previously treated metastatic colorectal cancer that is microsatellite stable (pMMR) and has spread to the liver.
The main questions it aims to answer are:
- What proportion of participants experience tumor shrinkage (objective response rate) based on imaging assessments?
- What side effects occur with this combination treatment, including immune-related and cytokine-related reactions?
All participants in this study will receive the combination treatment. There is no comparison group.
Participants will:
- Receive balstilimab, botensilimab, and agenT-797 in repeating 42-day treatment cycles
- Undergo imaging scans (such as CT or MRI) to assess tumor response
- Have blood samples collected to monitor safety and evaluate biomarkers
- Provide tumor tissue samples for research
- Be monitored for side effects throughout the study
- Participate in follow-up visits to assess survival after treatment completion
Conditions: Colorectal Cancer Metastatic
Interventions: Balstilimab (BAL), Botensilimab (BOT), agenT-797
Mentioned entities
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.