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A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT05929235•Flare Therapeutics Inc.

View on ClinicalTrials.gov

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.

Detailed Description

This is an open-label Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of FX-909 given orally (PO) in patients with advanced solid malignancies. Initially, FX-909 will be given in a dose-escalation phase (Part A) to determine the preliminary recommended phase 2 dose (RP2D). Part B will be a dose expansion phase to further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of FX-909 in patients with locally advanced (unresectable) and metastatic urothelial carcinoma. Part 1A1 will be a dose escalation of FX-909 in combination with Pembrolizumab. Throughout the study patients will be treated in 28 or 21-day cycles.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Able to understand and willing to sign an informed consent.
•2. Age ≥ 18 years.
•3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
•4. An archival, paraffin-embedded, formalin-fixed, tumor sample (see Laboratory Manual for details) that in Part A is no more than 30 months old at the time of screening or in Part B is no more than 30 months old at time of pre-screening. If an archival tumor sample is not available or is older than 30 months, then the patient must consent to provide a fresh biopsy during screening.
•5. Part A: Histologically or cytologically diagnosed, locally advanced (unresectable) or metastatic solid malignancies that have progressed after all available standard therapy for the specific tumor type, or for which no standard therapy exists. Patients for whom standard therapies are intolerable or considered inappropriate by the Investigator are eligible.
•Part B: Patients with histologically or cytologically confirmed, locally advanced (unresectable) or metastatic urothelial carcinoma exhibiting high levels of PPARG protein expression will be prospectively enrolled in this study. Eligibility will require a Tumor Positivity Score (TPS) of ≥ 60%, as determined by an investigational immunohistochemistry (IHC) assay for PPARG.
•• Treated with ≤ 4 prior therapies for advanced or metastatic disease Patients in Part B must have progressed after all available standard therapy, been unable to tolerate standard therapy, or be considered inappropriate for standard therapy by the Investigator.
•6. Part A: Patients with or without measurable disease (as defined by RECIST version 1.1) will be eligible for enrollment.
•Part B: Patients must have measurable disease per RECIST version 1.1 with ≥ 1 site of measurable disease that has not been previously irradiated or has progressed after radiation therapy.
•7\. Screening laboratory values meet the criteria outlined in Table 8.
+26 more criteria

Exclusion Criteria

•1. Female patients who are pregnant (confirmed with a positive pregnancy test) or breastfeeding.
•2. Prior anticancer chemotherapy or small molecule targeted therapy, either investigational or commercially approved and available, within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of study drug administration. When the most recent therapy was a biological therapy (including antibody-drug conjugates), an immune-checkpoint inhibitor (eg, anti-PD(L)1 or anti-CTLA4), or immune agonist, patients should wait 4 weeks before starting therapy with FX-909. (See Exclusion Criterion 6 for required radiotherapy windows.)
•3. Prior therapy directly inhibiting PPARG or RXRA.
•4. Adverse events from prior therapy that have not returned to baseline or stabilized at Grade 1 (except alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade ≤ 2 neuropathy) prior to study drug administration.
•5. Prior major surgery (excluding placement of vascular access) within 4 weeks before study drug administration.
•6. Prior radiation therapy with an inadequate washout between the last dose and the start of study drug, defined as follows: 1) at least 2 weeks for palliative radiation to the extremities for osseous bone metastases is required; and 2) at least 4 weeks for radiation to non-extremity sites is required.
•7. History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. Exceptions include appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, melanoma in situ status-post full-thickness resection without recurrence, Stage 1 uterine cancer, localized prostate cancer that has been treated surgically with curative intent and presumed cured, or other malignancies with an expected curative outcome. Patients requiring adjuvant therapy within the past 2 years for another malignancy will not be considered to have been cured.
•8. QT interval corrected using Fridericia's Formula (QTcF) \>470 msec in screening, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives.
•9. Known active diagnosis of lipodystrophy/lipoatrophy, or an ongoing need to receive medications known to cause lipodystrophy/lipoatrophy.
•10. Any active uncontrolled systemic bacterial, viral, or fungal infection requiring treatment.
+56 more criteria

Locations (11)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

The University of Chicago Medicine

Chicago, Illinois, United States

Mass General Cancer Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Slone Kettering Cancer Center

New York, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Key Dates

Start Date

August 24, 2023

Primary Completion Date

October 30, 2027

Completion Date

January 30, 2028

Last Updated

January 30, 2026

Enrollment

120

ESTIMATED participants

Conditions

Advanced Urothelial CarcinomaOral Drug AdministrationOpen Label

Interventions

FX-909

DRUG

Pembrolizumab (KEYTRUDA ®)

DRUG

KEYTRUDA ®( Pembrolizumab)

DRUG

Contacts

Jennifer Tepper, Associate Director, Clinical Operations

CONTACT

9083097228 clinops@flaretx.com

Carolyn McCrone, Sr Clinical Trial Associate

CONTACT

clinops@flaretx.com

Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma

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RECRUITINGPHASE2

Probiotics in Advanced Urothelial Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma

Probiotics in Advanced Urothelial Carcinoma

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