A Phase 1 Study in Patients With Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Flare Therapeutics Inc.
Study ID
NCT07719361
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Castration Resistant Prostate Cancer
  • Neoplasms Prostate
  • Neoplasms of Prostate
  • Prostatic Neoplasms
  • Prostatic Neoplasms, Castration-Resistant
  • mCRPC
  • mCRPC (Metastatic Castration-resistant Prostate Cancer)
  • mCRPC or Advanced/Metastatic Solid Tumors
  • mCRPC, Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

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

Interventions

  • FX-111 — DRUG
    FX-111 will be administered orally once daily in continuous 28-day cycles.

Study Details

The goal of this clinical trial is to find out if FX-111 is safe enough to permit further studies in adult male participants with metastatic castration-resistant prostate cancer (mCRPC). It will also study the drug's pharmacokinetics (how the body breaks down FX-111) and how well FX-111 treats mCRPC. The main questions it aims to answer are: What are the side effects of FX-111? Does FX-111 work to reduce or prevent progression of mCRPC? The study doctor will oversee participants' treatment with FX-111 and ask about any side effects. Participants will take FX-111 every day by mouth and will have regular physical and laboratory examinations to check health and tumor status.

Key Dates

First listed
Jul 22, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Feb 15, 2028
Completion
Feb 15, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: FX-111 Dose Level 1
  • Experimental: FX-111 Dose Level 2
  • Experimental: FX-111 Dose Level 3
  • Experimental: FX-111 Dose Level 4
  • Experimental: FX-111 Dose Level 5

Primary Outcome Measure

The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111 [ Time Frame: Study day 1 throughout the study, estimated to be 6 months. ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
START Los AngelesLos AngelesCalifornia90025
Hope Team Distribution List
[email protected]
424-465-1820
Navid Hafez, MD, MPH (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Xin Gao, MD (PRINCIPAL_INVESTIGATOR)
START MidwestGrand RapidsMichigan49546
Hope Team Distribution List
[email protected]
616-389-1810
Emerson Lim, MD (PRINCIPAL_INVESTIGATOR)
START New JerseyEast BrunswickNew Jersey08816
Emily Lichtenstein
[email protected]
732-426-4750
Bruno Fang, MD (PRINCIPAL_INVESTIGATOR)
START CarolinasMyrtle BeachSouth Carolina29572
Kate Valipour, Clinical Research Coordinator
[email protected]
843-449-1010
Paige Wilson
[email protected]
843-449-1010
Neal Shore, MD (PRINCIPAL_INVESTIGATOR)
Tennessee OncologyNashvilleTennessee37203
Katy Beckermann, MD, Ph.D. (PRINCIPAL_INVESTIGATOR)
START Dallas-Fort WorthFort WorthTexas76104
Hope Team Distribution List
[email protected]
682-350-3010
Salwan Al Mutar, MD, M.Sc. (PRINCIPAL_INVESTIGATOR)
NEXT HoustonHoustonTexas77054
Jennifer Segar, MD (PRINCIPAL_INVESTIGATOR)
NEXT OncologySan AntonioTexas78229
Ildefonso Ismael Rodriguez Rivera, MD (PRINCIPAL_INVESTIGATOR)
NEXT VirginiaFairfaxVirginia22031
Mohamad Salkeni, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
START Los Angeles· Los Angeles, CAMassachusetts General Hospital· Boston, MASTART Midwest· Grand Rapids, MISTART New Jersey· East Brunswick, NJSTART Carolinas· Myrtle Beach, SCTennessee Oncology· Nashville, TN

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