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Can a new daily pill slow advanced prostate cancer?

NCT ID NCT07719361

Disease control Sponsor: Flare Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Aug 05, 2026 · Updated 5 times

Summary

This early-stage trial tests whether an experimental drug called FX-111 is safe enough to study further in men with metastatic castration-resistant prostate cancer (mCRPC), a form of advanced prostate cancer that no longer responds to standard hormone therapy. Participants take FX-111 by mouth once daily and are monitored for side effects, how the drug moves through the body, and whether it can slow tumor growth. The study aims to find the right dose and gather initial signs of effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental oral drug called FX-111
What this could lead to
If safe and effective, FX-111 could offer a new treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is a very early, small Phase 1 trial focused on safety and dosing, not on proving the drug works. Side effects are unknown, and many early-stage drugs never advance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer prostate neoplasm Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MCRPC MCRPC (metastatic castration-resistant prostate cancer) MCRPC or advanced/metastatic solid tumors Metastatic castration-resistant prostate cancer Neoplasms of prostate Neoplasms, prostate Prostatic neoplasms Prostatic neoplasms, castration-resistant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • NEXT Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • START Carolinas

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • START Dallas-Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • START Los Angeles

    RECRUITING

    Los Angeles, California, 90025, United States

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START New Jersey

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Tennessee Oncology

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37203, United States

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