Recruiting

Phase 1

FX-111A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

Sponsor:

Flare Therapeutics Inc.

Code:

NCT07719361

Conditions

Metastatic Castration Resistant Prostate Cancer

mCRPC

mCRPC (Metastatic Castration-resistant Prostate Cancer)

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FX-111

Study Details

Brief summary:

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.

Conditions

Metastatic Castration Resistant Prostate Cancer

mCRPC

mCRPC (Metastatic Castration-resistant Prostate Cancer)

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Study ID

NCT07719361

Start date

Jul 1, 2026

Status verified date

Jul, 2026

Completion date

Feb 15, 2029

Anticipated

Primary completion date

Feb 15, 2028

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Confirmed adenocarcinoma of the prostate.
PSA levels ≥ 2 ng/mL at screening visit.
Progressing PSA, defined as two consecutive increases in the most recent PSA measurements taken at least 1 week apart.
Progressed on Androgen Deprivation Therapy (ADT) and at least one prior potent Androgen Receptor (AR) pathway inhibitor given in castration-sensitive prostate cancer setting or approved for castration-resistant prostate cancer (eg, apalutamide, darolutamide, abiraterone, enzalutamide).
Ongoing primary ADT with gonadotropin-releasing hormone agonist or antagonist in the absence of bilateral orchiectomy.
Acceptable physical functioning and laboratory measurements, per the study protocol.
Discontinued prior therapies within protocol-specified timeframes.
Commit to use of highly-effective contraception while on study and for 90 days after.
Willing and able to adhere to the study visit schedule and other protocol defined requirements.

Exclusion Criteria:

Predominance of small cell carcinoma of the prostate/neuroendocrine prostate cancer in most recent tumor biopsy.
Participants with brain metastases that require ongoing treatment with radiation or high-dose steroids.
Not recovered from side effects of prior surgery or cancer treatments.
Evidence of active viral, bacterial, or fungal infection requiring treatment with antivirals, antibiotics, or anti-fungal medications.
Prior treatment with AR degraders and molecules with an AR ligand such as AR Regulated Induced Proximity Targeting Chimera (RIPTAC).
Blood clots ≤ 4 weeks prior to start of treatment.
Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drug. Patients may be eligible if the malignancy is clinically stable or has been treated with curative intent.
Any evidence of severe or uncontrolled systemic diseases.
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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

FX-111

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

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 and Locations

Central contacts

Janine Koucheki, Associate Director, Clinical Operations

857-706-4400 clinops@flaretx.com

Carolyn McCrone, Sr Clinical Trial Associate

857-706-4400 clinops@flaretx.com

Locations

START Los Angeles

Recruiting

Los Angeles, California, United States, 90025

Contacts

Hope Team Distribution List

424-465-1820 hopeteam@startresearch.com

Principal Investigator:

Navid Hafez, MD, MPH

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Hope Team Distribution List

616-389-1810 hopeteam@startresearch.com

Principal Investigator:

Emerson Lim, MD

START New Jersey

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

Nurse Navigator

732-426-4750 dana.sapia@startresearch.com

Principal Investigator:

Bruno Fang, MD

START Carolinas

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Contacts

Kate Valipour, Clinical Research Coordinator

843-449-1010 kate.valipour@startresearch.com

Paige Wilson

843-449-1010 paige.wilson@startresearch.com

Principal Investigator:

Neal Shore, MD

START Dallas-Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Hope Team Distribution List

682-350-3010 hopeteam@startresearch.com

Principal Investigator:

Salwan Al Mutar, MD, M.Sc.

NEXT Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Emma Morales

emorales@nextoncology.com

Principal Investigator:

Jennifer Segar, MD

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jordan Georg

jgeorg@nextoncology.com

Principal Investigator:

Ildefonso Ismael Rodriguez Rivera, MD

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle De La Rosa

mdelarosa@nextoncology.com

Principal Investigator:

Mohamad Salkeni, MD

More Information

Sponsor

Flare Therapeutics Inc.

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Flare Therapeutics Inc. on 2026-08-04.