NCT07719361 FX-111 Metastatic Solid Tumor Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07719361 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 NCT07719361 is a hot trial to watch
Metastatic Solid Tumor is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07719361 is notable because it evaluates FX-111 in a Phase 1 design sponsored by Flare Therapeutics, Inc.. 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 | NCT07719361 |
| Official title | A Study in Patients With Metastatic Castration-Resistant Prostate Cancer |
| Phase / status | Phase 1 / Recruiting |
| Intervention | FX-111 |
| Sponsor | Flare Therapeutics, Inc. |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111 |
| Endpoint time frame | Study day 1 throughout the study, estimated to be 6 months. |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The goal of this clinical trial is to find out if FX-111 is safe enough to permit further studies in adult male participants with metastatic castration-resistant prostate cancer (mCRPC). It will also study the drug's pharmacokinetics (how the body breaks down FX-111) and how well FX-111 treats mCRPC. The main questions it aims to answer are: What are the side effects of FX-111? Does FX-111 work to reduce or prevent progression of mCRPC? The study doctor will oversee participants' treatment with FX-111 and ask about any side effects. Participants will take FX-111 every day by mouth and will have regular physical and laboratory examinations to check health and tumor status.
Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Sequential 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.
- The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111 (Study day 1 throughout the study, estimated to be 6 months.)
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: FX-111 is indexed as Small molecule drug, with target AR, mechanism AR degraders, and global highest development status Phase 1.
Company & Deal Intelligence MCP profile: Flare Therapeutics, Inc. did not return an exact normalized organization match in this snapshot. 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
NCT07719361 provides a focused lens on Metastatic Solid Tumor development. Its value will be determined by whether FX-111 can convert the current Phase 1 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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