A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
Public ClinicalTrials.gov record NCT05929235. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, First-in-Human, Dose-Escalation and Expansion Study of FX-909 (as Monotherapy or in Combination With Pembrolizumab) in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05929235
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 120 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 24, 2023 (Actual)
- Primary completion
- Oct 30, 2027 (Estimated)
- Completion
- Jan 30, 2028 (Estimated)
- Last update posted
- Aug 12, 2026
2023 – 2028
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | — |
| Yale Cancer Center | New Haven | Connecticut | 06519 | — |
| Sylvester Comprehensive Cancer Center, University of Miami | Miami | Florida | 33136 | — |
| The University of Chicago Medicine | Chicago | Illinois | 60637 | — |
| Mass General Cancer Center | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Memorial Slone Kettering Cancer Center | New York | New York | 10065 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27514 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Houston Methodist Cockrell Center for Advanced Therapeutics | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05929235, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2026 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05929235 live on ClinicalTrials.gov.