Ipilimumab N01 in MSI-H/dMMR Rectal Cancer: NCT07750951 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 2
Clinical phase
Recruiting
Recruitment status
34
Planned enrollment
2026-11-01
Primary-completion proxy
Executive view
NCT07750951 evaluates Ipilimumab N01 in MSI-H/dMMR Rectal Cancer. The disclosed sponsor is Xijing Hospital, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Pathological complete response (PCR) rate, assessed over Surgery (within 4-6 weeks of the last administration).
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07750951 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider MSI-H/dMMR Rectal Cancer landscape. Drug & Asset MCP drug_fetch was queried for Ipilimumab N01, while Company & Deal Intelligence MCP organization_fetch was queried for Xijing Hospital.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07750951 | Ipilimumab N01 | Phase 2 / Recruiting | Xijing Hospital | China | Pathological complete response (PCR) rate Surgery (within 4-6 weeks of the last administration) | 2026-11-01 |
| NCT07769853 | Iparomlimab/Tuvonralimab | Not Applicable / Not yet recruiting | Zhejiang University | Geography not reported | Clinical Complete Response (CCR) 3 weeks After last round of neoadjuvant treatment | 2027-07-01 |
| NCT07764497 | Floxuridine | Phase 2 / Recruiting | Sunnybrook Health Sciences Centre | Canada | Proportion of participants that undergo liver resection following treatment with FUDR From time of consent to approximately 42 days from last treatment wit… | 2036-12-01 |
| NCT07765667 | Ascorbic Acid | Phase 2 / Not yet recruiting | The Sixth Affiliated Hospital of Sun Yat-Sen University | China | pCR rate 1 year | 2029-09-01 |
| NCT07750041 | Bevacizumab biosimilar(Qilu Pharmaceutical Co., Ltd.) | Phase 1/2 / Not yet recruiting | CSPC Megalith Biopharmaceutial Co., Ltd. | China | Recommended Phase 2 Dose (RP2D), Safety and Tolerability up to approximately 3 years after the first enrollment | 2027-12-31 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07750951 is a Phase 2, recruiting study with 34 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Pathological complete response (PCR) rate” over “Surgery (within 4-6 weeks of the last administration).” The retrieved endpoint description is: The proportion of subjects with no residual viable tumor cells and negative lymph nodes in the total subjects.
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 34 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for MSI-H/dMMR Rectal Cancer. These records do not establish direct evidence for NCT07750951 unless the registration number matches.
Randomized phase-II trial of surufatinib plus FOLFOX/FOLFIRI versus FOLFOXIRI as second-line therapy for metastatic colorectal cancer
Phase 2; n=57; ORR = 39.3 % ( 21.5 - 59.4); ORR = 35.7 % ( 18.6 - 55.9) Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42421558/
Phase II Study of Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma
Phase 2; n=11; No numerical result field reported Source: https://clinicaltrials.gov/ct2/show/results/NCT02023333
Aspirin for cancer prevention in individuals with Lynch syndrome: first results from the CaPP3 multicentre, randomised, double-blind, non-inferiority trial
Phase 3; n=1879; Lynch syndrome cancers = 75.0 Participant ; Lynch syndrome cancers = 57.0 Participant Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42425127/
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Ipilimumab N01 is indexed as Biosimilar with CTLA4 biology and a global stage of Approved. The asset profile lists Innovent Biologics (Suzhou) Co. Ltd. as an originator or developer.
Xijing Hospital is indexed in China with the website http://www.xjwww.fmmu.edu.cn. Operates general medical hospitals The record lists 11 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Ipilimumab N01 is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07750951
Protocol source: https://clinicaltrials.gov/study/NCT07750951
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 18 September 2026.
Ipilimumab N01 in MSI-H/dMMR Rectal Cancer is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Pathological complete response (PCR) rate and 2026-11-01 the leading decision points.
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