NCT07451795 Retlirafusp alfa Metastatic castration-resistant prostate cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07451795 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: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07451795 is a hot trial to watch
Metastatic castration-resistant prostate cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07451795 is notable because it evaluates Retlirafusp alfa in a Phase 2 design sponsored by Fudan University. 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 | NCT07451795 |
| Official title | SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC (SHARP) |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Retlirafusp alfa |
| Sponsor | Fudan University |
| Geography | China |
| Enrollment | 66 |
| Primary endpoint | Radiographic Progression-Free Survival (rPFS) |
| Endpoint time frame | From randomization to radiographic progression or death (up to 24 months) |
| Primary completion / readout proxy | 2028-03-31 |
Protocol design and endpoint interpretation
The aim of this study is to evaluate the efficacy of SHR-1701 in combination with SBRT in patients with metastatic castration-resistant prostate cancer. Dr. Yao Zhu from Fudan University Shanghai Cancer Center is the co-leading PI of this study.
Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of 66 participants across China 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.
- Radiographic Progression-Free Survival (rPFS) (From randomization to radiographic progression or death (up to 24 months)) — Description: Defined as bone disease progression (occurrence of two or more new lesions on bone scan) per PCWG3, or soft tissue/clinical progression per RECIST v1.1.
Readout outlook and evidence gap
The current protocol points to 2028-03-31 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: Retlirafusp alfa is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Fudan University is resolved to a normalized organization record in Shanghai Shi, China. 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
NCT07451795 provides a focused lens on Metastatic castration-resistant prostate cancer development. Its value will be determined by whether Retlirafusp alfa can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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