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FX-909 for Advanced Solid Tumors, Including Urothelial Carcinoma

This study is testing a new oral drug called FX-909, alone and with Pembrolizumab (KEYTRUDA®), an immunotherapy, for people with advanced solid tumors, including advanced urothelial carcinoma (a type of bladder cancer). Researchers want to find out if FX-909 is safe and what the right dose is. FX-909 works by affecting a protein called PPARG. You might be eligible if you are 18 or older, have a good general health status (ECOG 0, 1, or 2), and can provide a recent tumor sample. The study will look at side effects and how well the drugs are tolerated. The study is currently recruiting 120 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It will involve about 120 participants.
What's involved
You will take FX-909 daily by mouth, and potentially Pembrolizumab every 3 weeks. You will have multiple site visits for blood tests, tumor samples, and regular CT/MRI scans.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored through study completion, which is an average of 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05929235

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Flare Therapeutics Inc.
~120 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:FX-909Pembrolizumab (KEYTRUDA ®)KEYTRUDA ®( Pembrolizumab)

At a glance

Recruiting sites
0 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess dose-limiting toxicities, the incidence and severity of adverse events and serious adverse events associated with FX-909 (Safety and Tolerability)
Measured over through study completion, an average of 3 years

Conditions

Advanced Urothelial Carcinoma
Oral Drug Administration
Open Label

Explore related trials

Solid NeoplasmUrothelial Carcinoma

Where it's being run

12 sites across 10 states
Massachusetts2
New York2
California1
Connecticut1
Florida1
Illinois1
North Carolina1
Ohio1

Study leadership

  • Gopa Iyer, MD · PRINCIPAL_INVESTIGATOR · Memorial Slone Kettering

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Congestive heart failure (Class III or IV) as defined by the New York Heart Association functional classification system
Recent history (within the past 6 months) of symptomatic pericarditis 21. Thromboembolic events and/or bleeding disorders ≤ 28 days (eg, deep vein thrombosis or pulmonary embolism) prior to the first dose of study drug. 22. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the study or would jeopardize compliance with the protocol. 23. Patients with type 1 diabetes mellitus, or type 2 diabetes mellitus that is not adequately controlled with diet, exercise, or oral hypoglycemic agents and/or injectable agents other than insulin (as defined by HbA1c and fasting plasma glucose criteria in Table 8. Patients taking insulin are excluded from the study. Medication for type 2 diabetes mellitus should have remained stable for the past 14 days prior to screening). 24. Known hypersensitivity to FX-909 or any of its excipients. 25. Patients with gastrointestinal disorders that may interfere with the ability to swallow tablets or absorb study medication. 26. Patient is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is a member of the study site or Sponsor staff directly involved with this study, unless prospective Institutional Review Board (IRB) or Ethics Committee (EC) approval (by chair or designee) is given allowing exception to this criterion for a specific patient. 27. Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before study entry. 28. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.

What this trial measures

  • To assess dose-limiting toxicities, the incidence and severity of adverse events and serious adverse events associated with FX-909 (Safety and Tolerability)through study completion, an average of 3 years

    Incidence of dose-limiting toxicities (DLTs); Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)