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A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
NCT05929235 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical trial is to study the safety and tolerability in all advanced solid tumors, including advanced urothelial carcinoma. The main question\[s\] it aims to answer are: * Is FX-909 safe and tolerable, as a monotherapy and in combination with Pembrolizumab * What is the right dose level for patients Participants will be asked to take FX-909 daily in tablet form, or FX-909 daily and Pembrolizumab every 3 weeks, and record any outcomes from taking the drug. Participants will also be asked to return for multiple site visits for various blood tests and to collect blood and tumor samples as well as have regular CT/MRI scans.
Conditions Studied
Interventions
- DRUG FX-909
- DRUG Pembrolizumab (KEYTRUDA ®)
- DRUG KEYTRUDA ®( Pembrolizumab)
Study Locations (11)
Massachusetts
- Mass General Cancer Center — Boston
- Dana Farber Cancer Institute — Boston
New York
- Icahn School of Medicine at Mount Sinai — New York
- Memorial Slone Kettering Cancer Center — New York
California
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
Connecticut
- Yale Cancer Center — New Haven
Illinois
- The University of Chicago Medicine — Chicago
North Carolina
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill
Ohio
- The Cleveland Clinic Foundation — Cleveland
Tennessee
- Sarah Cannon Research Institute — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-08-24 |
| Est. Completion | 2028-01-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05929235
The ClinicalTrials.gov registry entry for NCT05929235 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Flare Therapeutics, which has 28 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Advanced Urothelial Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which FX-909 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05929235 reports 11 study locations spanning 9 distinct geographic areas — top geographies include Massachusetts, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05929235 about?
NCT05929235 is a clinical study titled "A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma". The goal of this clinical trial is to study the safety and tolerability in all advanced solid tumors, including advanced urothelial carcinoma. The main question\[s\] it aims to answer are: * Is FX-909 safe and tolerable, as a monotherapy and in combination with Pembrolizumab * What is the right do...
What is the current status of trial NCT05929235?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2023-08-24. Estimated completion is 2028-01-30.
What conditions does trial NCT05929235 study?
This clinical trial studies the following conditions: Advanced Urothelial Carcinoma, Oral Drug Administration, Open Label. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05929235?
The interventions under investigation include: FX-909 (DRUG), Pembrolizumab (KEYTRUDA ®) (DRUG), KEYTRUDA ®( Pembrolizumab) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05929235?
This trial is sponsored by Flare Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05929235 being conducted?
This trial has 11 study locations across California, Connecticut, Illinois, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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