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NCT05929235 · ClinicalTrials.gov registry record · Phase 1
A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
A Phase 1 study of Advanced Urothelial Carcinoma and Oral Drug Administration, sponsored by Flare Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 11
- Study locations
NCT05929235: Recruiting Phase 1 study of Advanced Urothelial Carcinoma and Oral Drug Administration, sponsored by Flare Therapeutics.
NCT05929235 is a Phase 1 study of Advanced Urothelial Carcinoma and Oral Drug Administration that is actively recruiting participants, run by Flare Therapeutics. The registered enrollment target is 120 participants, roughly in line with the 120-participant average among 5 other Advanced Urothelial Carcinoma trials with a reported enrollment target. The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05929235, a Phase 1 study of Advanced Urothelial Carcinoma and Oral Drug Administration, is actively recruiting participants, sponsored by Flare Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
Incidence of dose-limiting toxicities (DLTs); Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
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 |
What NCT05929235 shows while recruiting
NCT05929235 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 120-participant average among 5 other Advanced Urothelial Carcinoma trials with a reported enrollment target.
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.
NCT05929235 lists 11 locations in 9 states (Massachusetts, New York, California).
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.
What interventions are being tested in trial NCT05929235?
The interventions under investigation include: FX-909 (DRUG), Pembrolizumab (KEYTRUDA ®) (DRUG), KEYTRUDA ®( Pembrolizumab) (DRUG).
Who is sponsoring clinical trial NCT05929235?
This trial is sponsored by Flare Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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