NCT07595874 Botensilimab Advanced Colorectal Adenocarcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07595874 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: 23 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07595874 is a hot trial to watch
Advanced Colorectal Adenocarcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07595874 is notable because it evaluates Botensilimab in a Phase 2 design sponsored by City of Hope National Medical Center. 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 | NCT07595874 |
| Official title | Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3 (NEST3) |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Botensilimab |
| Sponsor | City of Hope National Medical Center |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Two-year disease-free survival rate |
| Endpoint time frame | At 2 years post enrollment |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This phase II trial tests how well giving botensilimab and balstilimab prior or to surgery (neoadjuvent) works for the treatment of colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that can be removed by surgery (resectable) colorectal cancer. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab before surgery may make the tumor smaller. Giving neoadjuvant botensilimab and balstilimab may be effective for the treatment of advanced resectable colorectal cancer.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across United States 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.
- Two-year disease-free survival rate (At 2 years post enrollment) — Defined as the percentage of patients that remain free from any signs of colon cancer at two years post-enrollment. Will be compared to the historical control rate of 76.8% (from the FoXTROT adjuvant chemotherapy arm) using a one-sided, one-sample log-rank test.
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: City of Hope National Medical Center is resolved to a normalized organization record in LOS ANGELES 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
NCT07595874 provides a focused lens on Advanced Colorectal Adenocarcinoma 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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