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New pill HLD-0915 takes on tough prostate cancer

NCT ID NCT06800313

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 4 times

Summary

This study tests an experimental oral drug called HLD-0915 in men with metastatic prostate cancer that has worsened after other treatments. The trial has two phases: Phase 1 checks safety and the best dose, while Phase 2 looks at how well it controls the cancer. About 190 men will take part across multiple groups.

What this could mean

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

Active substance
HLD-0915 (oral drug)
What this could lead to
If successful, this could provide a new oral treatment option for men with metastatic prostate cancer that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects and limited benefit are possible.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 190 people

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

Started

Feb 2025

Expected to finish

Jul 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.

Patients must meet the following criteria to be eligible study participation: Key Inclusion Criteria: All Study Arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D): Males ≥ 18 years old Histological, pathological, and/or cytological confirmation of prostate adenocarcinoma Adequate hematological, renal, and hepatic function. Able to swallow oral medication mCRPC Arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Prior orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone Progressive mCRPC defined as having demonstrated PSA progression on the prior regimen SOAR Arm (Phase 2 Part 2A) mHSPC with distant metastatic disease based on conventional imaging PSA ≥0.2 ng/mL, following treatment with next generation ARPI for at least 180 days and up to 365 days No evidence of radiographic or PSA progression while receiving ARPI mHSPC arms (Phase 2 Part 2B, 2C \& 2D) serum testosterone \>150ng/ml mHSPC with distant metastatic disease based on conventional imaging and PSA \>2.0 ng/mL Key Exclusion Criteria: All arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D): Has experienced a recent major bleed or has a known bleeding disorder Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology Receiving continuous corticosteroids at prednisone-equivalent dose of \>10 mg/day Prior or ongoing significant medical condition mCRPC arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Has received systemic anti-cancer therapy or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods SOAR arm (Phase 2 Part 2A) Has received any prior cytotoxic chemotherapy for prostate cancer mHSPC arms (Phase 2 Part 2B, 2C \& 2D) regional pelvic lymph node disease only

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Conditions

The condition(s) this trial relates to.

adenocarcinoma castration-resistant prostate carcinoma epithelial neoplasm male reproductive organ cancer male reproductive system disorder Male Urogenital Diseases metastatic prostate carcinoma prostate cancer Urogenital Neoplasms

As listed by the trial registrant

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

Metastatic prostate cancer Prostate cancer (adenocarcinoma) Prostate cancer metastatic disease

How to take part

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

  1. The places running it

    18 sites in 2 countries. 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

  • Associated Medical Professionals

    RECRUITING

    Syracuse, New York, 13210, United States

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Dana Farber Mass General Brigham Cancer Care Inc

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    Long Island City, New York, 11101, United States

  • NEXT Oncology

    RECRUITING

    Austin, Texas, 78758, United States

  • Rocky Mountain Cancer Center

    RECRUITING

    Colorado Springs, Colorado, 80909, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute 1

    RECRUITING

    Denver, Colorado, 80218, United States

  • South Texas Accelerated Research Therapeutics, LLC (START)

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • The Royal Marsden NHS Trust

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Urology Associates

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • Urology Cancer Center, PC

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • Virginia Clinical Research

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • XCancer Research Network LCMC Health EJGH

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06511, United States

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