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

Part of paid clinical trials in San Francisco, California.

Sponsor
Flare Therapeutics Inc.
Study ID
NCT05929235
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Urothelial Carcinoma
  • Open Label
  • Oral Drug Administration

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FX-909 — DRUG
    FX-909 is an orally available new molecular entity that inhibits basal- and ligand-activated transcription by PPARG.
  • Pembrolizumab (KEYTRUDA ®) — DRUG
    Pembrolizumab is an immunotherapy checkpoint inhibitor.
  • KEYTRUDA ®( Pembrolizumab) — DRUG
    Keytruda is an immunotherapy checkpoint inhibitor.

Study Details

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.

Key Dates

Start date
Aug 24, 2023
Status verified
Apr 2026
Primary completion
Oct 30, 2027
Completion
Jan 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    3+3 design, 5 dose levels
  • Experimental: Expansion Expansion
    Part B will proceed in a 2-stage design that will investigate 2 dose arms of FX-909 in Stage 1; with a single arm in Stage 2 envisioned.
  • Experimental: FX-909 in Combination with Pembrolizumab
    Part 1A1 will be a dose-escalation study to investigate FX-909 in combination with Pembrolizumab.

Primary Outcome Measure

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

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
Terry Friedlander, MD (PRINCIPAL_INVESTIGATOR)
Yale Cancer CenterNew HavenConnecticut06519
Amanda Davis, LPN
[email protected]
(475) 321-7899
Daniel Petrylak, MD (PRINCIPAL_INVESTIGATOR)
Sylvester Comprehensive Cancer Center, University of MiamiMiamiFlorida33136
Isabel Fernandez
[email protected]
305-243-5486
Jaime R Merchan, MD MMSc (PRINCIPAL_INVESTIGATOR)
The University of Chicago MedicineChicagoIllinois60637
Randy Sweis, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Kerri Maron
[email protected]
(617) 632-6627
Joaquim Bellmunt, MD, Ph.D. (PRINCIPAL_INVESTIGATOR)
Mass General Cancer CenterBostonMassachusetts02114
Xin Gao, MD
[email protected]
617-724-4000
Xin Gao, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Erin Heath
[email protected]
646-901-3172
Matthew Galsky, MD (PRINCIPAL_INVESTIGATOR)
Memorial Slone Kettering Cancer CenterNew YorkNew York10065
Gopakumar V Iyer, MD
[email protected]
646-888-4737
Gopa Iyer, MD (PRINCIPAL_INVESTIGATOR)
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27514
Matthew Milowsky, MD (PRINCIPAL_INVESTIGATOR)
The Cleveland Clinic FoundationClevelandOhio44195
Cancer Answer
[email protected]
216-444-7923
Shilpa Gupta, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research InstituteNashvilleTennessee37203
askSARAH
844-482-4812
Benjamin Garmezy, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist Cockrell Center for Advanced TherapeuticsHoustonTexas77030
Patrick Prath, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
UCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAYale Cancer Center· New Haven, CTSylvester Comprehensive Cancer Center, University of Miami· Miami, FLThe University of Chicago Medicine· Chicago, ILDana Farber Cancer Institute· Boston, MAMass General Cancer Center· Boston, MA

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