NCT07551596 Botensilimab MSS/pMMR/MSI-L Colorectal Carcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07551596 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 3 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07551596 is a hot trial to watch
MSS/pMMR/MSI-L Colorectal Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07551596 is notable because it evaluates Botensilimab in a Phase 2 design sponsored by National Cancer Institute. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07551596 |
| Official title | Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Botensilimab |
| Sponsor | National Cancer Institute |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Circulating tumor deoxyribonucleic acid (ctDNA) clearance |
| Endpoint time frame | Up to 6 months |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
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.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Circulating tumor deoxyribonucleic acid (ctDNA) clearance (Up to 6 months) — Will be defined as clearance of ctDNA and no radiographic evidence of disease. Will estimate clearance rate and its 95% confidence interval.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Botensilimab is indexed as Monoclonal antibody, with target CTLA4, mechanism CTLA4 inhibitors, and global highest development status Phase 3.
Company & Deal Intelligence MCP profile: National Cancer Institute is resolved to a normalized organization record in MONTGOMERY COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07551596 provides a focused lens on MSS/pMMR/MSI-L Colorectal Carcinoma development. Its value will be determined by whether Botensilimab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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