NCT07729371 ST-316 Adenomatous Polyposis Coli Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07729371 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 NCT07729371 is a hot trial to watch
Adenomatous Polyposis Coli is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07729371 is notable because it evaluates ST-316 in a Phase 1 design sponsored by Sapience Therapeutics Ltd.. 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 | NCT07729371 |
| Official title | A Safety Study of ST316 in Participants With Familial Adenomatous Polyposis (FAP). (FAP) |
| Phase / status | Phase 1 / Not yet recruiting |
| Intervention | ST-316 |
| Sponsor | Sapience Therapeutics Ltd. |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Incidence of Treatment Related Adverse Events By CTCAE V5.0 Severity Grade |
| Endpoint time frame | From first dose through 30 days after last dose |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This is a Phase 1b, open- label, dose-optimization study evaluating ST316 in adult participants with familial adenomatous polyposis (FAP) who have undergone colectomy and have recurrent polyps. This study uses a three-cohorts, sequential adaptive design to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ST316, as well as its preliminary efficacy in reducing polyp recurrence.
Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Sequential 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.
- Incidence of Treatment Related Adverse Events By CTCAE V5.0 Severity Grade (From first dose through 30 days after last dose) — Numbers and percentage of participants with treatment-related adverse events as assessed by severity grade (CTCAE V5); incidence of SAEs;
- Percentage change from Baseline in Colorectal/ Pouch Poly Burden (Sum in Diameters) at Month 6 (1 year) — Percentage change from baseline to Month 6 in the sum of diameters of colorectal/ pouch and duodenal polyp burden (sum in diameters) as assessed by endoscopy
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: ST-316 is indexed as Recombinant polypeptide, with target CTNNB, mechanism CTNNB inhibitors, and global highest development status Phase 2.
Company & Deal Intelligence MCP profile: Sapience Therapeutics Ltd. is resolved to a normalized organization record in Ireland. 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
NCT07729371 provides a focused lens on Adenomatous Polyposis Coli development. Its value will be determined by whether ST-316 can convert the current Phase 1 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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