A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

ClinicalTrials.gov ID: NCT07719361

Public ClinicalTrials.gov record NCT07719361. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 10, 2026, 3:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, First-in-Human, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FX-111 in Patients With Metastatic Castration-Resistant Prostate Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07719361
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Flare Therapeutics Inc.; Industry
Enrollment: 60 participants

Conditions and interventions

Conditions

Interventions

FX-111 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: Male
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 30, 2026
Primary completion: Feb 14, 2028
Completion: Feb 14, 2029
Last update posted: Aug 3, 2026

2026 – 2029

United States locations

U.S. sites: 10
U.S. states: 8
U.S. cities: 10

Facility	City	State	ZIP	Site status
START Los Angeles	Los Angeles	California	90025	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Not yet recruiting
START Midwest	Grand Rapids	Michigan	49546	Recruiting
START New Jersey	East Brunswick	New Jersey	08816	Recruiting
START Carolinas	Myrtle Beach	South Carolina	29572	Recruiting
Tennessee Oncology	Nashville	Tennessee	37203	Not yet recruiting
START Dallas-Fort Worth	Fort Worth	Texas	76104	Recruiting
NEXT Houston	Houston	Texas	77054	Recruiting
NEXT Oncology	San Antonio	Texas	78229	Recruiting
NEXT Virginia	Fairfax	Virginia	22031	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07719361, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 3, 2026 · Synced Sep 10, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07719361 live on ClinicalTrials.gov.

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