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New drug targets Hard-to-Treat prostate cancer

NCT ID NCT06842498

Disease control Sponsor: Kyntra Bio 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This phase 2 trial tests a drug called FG-3246, which is designed to seek out and attack prostate cancer cells that have a specific marker (CD46) on their surface. The study will enroll 75 men with metastatic castration-resistant prostate cancer that has worsened after hormone therapy. Researchers will monitor safety, how well the drug works, and how long it keeps the cancer from growing.

What this could mean

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

Active substance
FG-3246 (a CD46-targeted antibody-drug conjugate)
What this could lead to
If successful, this could provide a new treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is an early Phase 2 trial with only 75 participants, so results may not apply to all patients. The drug may cause side effects or fail to improve survival.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

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

Started

Feb 2026

Expected to finish

Mar 2028

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.

Key Inclusion Criteria: * Participant must have histological, and/or cytological confirmation of prostate adenocarcinoma on all prior tumor biopsies. * Participant with soft tissue disease and a safely accessible soft tissue tumor lesion(s) must agree to biopsy of a primary or metastatic lesion during screening. Alternatively, participant may provide a suitable archival biopsy of a primary or metastatic lesion. * Participant must have serum testosterone levels \<50 nanograms (ng)/deciliter (dL) during screening. * Participant is required to have progressed on no more than one prior treatment with a second generation ARSI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) initiated in either the castration-sensitive or castration-resistant setting. * Participant must have progressive mCRPC following last treatment at screening. * Participant must have ≥1 metastatic lesion that is present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤28 days prior to randomization. * Participant must have adequate organ function during screening. Key Exclusion Criteria: * Participant has received previous treatment with a therapeutic targeting CD46. * Participant has small cell neuroendocrine carcinoma (pure or mixed) on any prior histologic evaluation of primary or metastatic lesion. * Participant has progressed on more than one prior second-generation ARSI in any setting or has received more than two prior second-generation ARSIs in any setting. * Participants must not have received recent anticancer treatments before enrollment. Ongoing supportive or hormonal therapies are allowed if they were started well before randomization and are continued without change. * Participant has received any prior radiation therapy within 14 days prior to randomization. * Participant has a known actionable mutation or gene alteration, for example, BRCA1 mutation, for which approved therapies are available, for example, PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. * Participant has National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 2 peripheral neuropathy at the time of screening from any etiology. * Participant has received any prior chemotherapy; however, one prior taxane-based chemotherapy in the castration-sensitive setting is allowed if completed \>12 months before randomization. * Participant has known hypersensitivity to the components of FG-3246 or its analogs or a history of allergic or anaphylactic reaction to human, humanized, or chimeric monoclonal antibodies. * Participant has diagnosis with any other malignancy in the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin. * Participant requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer drug that cannot be safely discontinued. NOTE: Other protocol-defined inclusion/exclusion may apply.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

Metastatic castration resistant prostate cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

  • Biogenix Molecular, LLC

    RECRUITING

    Miami, Florida, 33165, United States

  • Bioresearch Partner - Aventura

    RECRUITING

    Aventura, Florida, 33180, United States

  • Bioresearch Partner - Hialeah

    RECRUITING

    Hialeah, Florida, 33013, United States

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Duke University Medical Center - Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • East Jefferson General Hospital Metairie

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Henry-Joyce Cancer Clinic

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • HonorHealth Research Institute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • New Haven Hospital - Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06519, United States

  • New Mexico Oncology Hematology Consultants, Ltd.

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

    Contact Email: •••••@•••••

  • Northwest Medical Specialties, PLLC - Tacoma

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Oncology Consultants

    RECRUITING

    Houston, Texas, 77030, United States

  • The University of Arizona Cancer Center - North Campus

    RECRUITING

    Tucson, Arizona, 85719, United States

  • UCLA Clark Urology Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Virginia Comprehensive Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • VA Greater Los Angeles Healthcare System

    RECRUITING

    Los Angeles, California, 90073, United States

  • Western Regional Medical Center - City of Hope Phoenix Goodyear

    RECRUITING

    Goodyear, Arizona, 85338, United States

  • Winship Cancer Institute, Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

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