A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

ClinicalTrials.gov ID: NCT05929235

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.

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ClinicalTrials.gov public records Last synced May 8, 2026, 8:09 AM EDT

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

Study identification

NCT ID: NCT05929235
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Flare Therapeutics Inc.; Industry
Enrollment: 120 participants

Conditions and interventions

Conditions

Interventions

FX-909 Drug
KEYTRUDA ®( Pembrolizumab) Drug
Pembrolizumab (KEYTRUDA ®) Drug

Drug

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 23, 2023
Primary completion: Oct 29, 2027
Completion: Jan 29, 2028
Last update posted: Apr 19, 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	Recruiting
Yale Cancer Center	New Haven	Connecticut	06519	Recruiting
Sylvester Comprehensive Cancer Center, University of Miami	Miami	Florida	33136	Recruiting
The University of Chicago Medicine	Chicago	Illinois	60637	Recruiting
Mass General Cancer Center	Boston	Massachusetts	02114	Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Recruiting
Memorial Slone Kettering Cancer Center	New York	New York	10065	Recruiting
UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	27514	Recruiting
The Cleveland Clinic Foundation	Cleveland	Ohio	44195	Recruiting
Sarah Cannon Research Institute	Nashville	Tennessee	37203	Recruiting
Houston Methodist Cockrell Center for Advanced Therapeutics	Houston	Texas	77030	Recruiting

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 Apr 19, 2026 · Synced May 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05929235 live on ClinicalTrials.gov.

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