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New drug combo aims to control Hard-to-Treat prostate cancer

NCT ID NCT07206056

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 18, 2026 · Updated 4 times

Summary

This study tests a new combination of two drugs (tulmimetostat and JSB462) in men with advanced prostate cancer that has spread and stopped responding to standard hormone therapy. The trial has two parts: first, finding the safest dose, then comparing the combination to usual care in 188 participants. The goal is to see if the combo can shrink tumors or lower PSA levels better than current treatments.

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 188 people

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

Started

Oct 2025

Expected to finish

Dec 2030

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 is an adult man ≥ 18 years of age. * Participant must have histologically and/or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell features (current or prior biopsy of the prostate and/or metastatic site). * Participant must have ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to start of treatment (Part 1a dose escalation) or randomization (Part 1b dose expansion and Part 2). * Participant must have progressive mCRPC. * Participant must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Prior ARPI therapy: * Part 1a and 1b only: must have progressed on at least one prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide). * Part 2 only: must have progressed on one prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide). * Prior chemotherapy: * Part 1a dose escalation only: may have received ≤ 2 prior lines of chemotherapy in CRPC setting. Note: Prior chemotherapy is permitted in the HSPC setting. * Part 1b dose expansion/optimization only: may have received up to one prior line of chemotherapy in CRPC setting. Note: Prior chemotherapy is permitted in the HSPC setting. * Part 2 only: Participants must be taxane-naïve in mCRPC setting; prior chemotherapy permitted in HSPC setting only Key Exclusion Criteria: * Previous treatment with any PRC2 inhibitor, including but not limited to EZH2 inhibitors, EZH2/1 inhibitors, or embryonic ectoderm development (EED) inhibitors. * Previous treatment with a protein degrader compound that targets the AR. * Known hypersensitivity or contraindication to any of the study treatment components or its excipients or to drugs of similar chemical classes. * Treatment with any investigational agent within 28 days (or 5 half-lives, whichever is longer) prior to study entry. * Previous treatment with radioligand therapy in the mCRPC setting, except in Part 1a where participants may have received RLT in mCRPC setting. * Participants with evidence of mCRPC or biochemical recurrence / PSA only disease or asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy and with normal PSA for ≥ 1 year prior to study entry. * Participants with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purpose of maintaining neurologic integrity. Those with leptomeningeal disease are eligible if those areas have been treated, are stable, and no neurological impairment is present. For those with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain with MRI (preferred) or CT with contrast. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma

As listed by the trial registrant

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

Progressive metastatic castrate resistant prostate cancer

How to take part

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

  1. The places running it

    35 sites in 14 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

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109-1024, United States

  • Mass General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Novartis Investigative Site

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Novartis Investigative Site

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Novartis Investigative Site

    RECRUITING

    Liverpool, 2170, Australia

  • Novartis Investigative Site

    RECRUITING

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100021, China

  • Novartis Investigative Site

    RECRUITING

    Herlev, 2730, Denmark

  • Novartis Investigative Site

    RECRUITING

    Odense C, 5000, Denmark

  • Novartis Investigative Site

    RECRUITING

    Vejle, 7100, Denmark

  • Novartis Investigative Site

    RECRUITING

    Bordeaux, 33076, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75015, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75231, France

  • Novartis Investigative Site

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Novartis Investigative Site

    RECRUITING

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    RECRUITING

    Padova, PD, 35128, Italy

  • Novartis Investigative Site

    RECRUITING

    Orbassano, TO, 10043, Italy

  • Novartis Investigative Site

    RECRUITING

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Tlalpan, Mexico City, 14050, Mexico

  • Novartis Investigative Site

    RECRUITING

    Poznan, 60-192, Poland

  • Novartis Investigative Site

    RECRUITING

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    RECRUITING

    Singapore, 308433, Singapore

  • Novartis Investigative Site

    RECRUITING

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28009, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28041, Spain

  • Novartis Investigative Site

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Sarah Cannon Research Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Wichita Urology Group PA

    RECRUITING

    Wichita, Kansas, 67226, United States