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New combo therapy aims to shrink prostate cancer tumors

NCT ID NCT07190300

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new drug called tulmimetostat combined with standard hormone therapies (darolutamide or abiraterone) in men whose prostate cancer has spread but still responds to hormone treatment. The goal is to see if the combination is safe and works better than standard care alone. About 181 men will take part, first in a small dose-finding phase, then in a larger phase comparing the combo to darolutamide alone.

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 181 people

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

Started

Jan 2026

Expected to finish

Aug 2032

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: * Adult men ≥ 18 years old with de novo or recurrent mHSPC (without neuroendocrine or small cell features). The tumor lesion(s) may be located in the bone, soft tissue/visceral region, or both. * Participants must have castrate levels of testosterone, i.e., ≤ 50 ng/dL (≤ 1.7 nM). * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Adequate bone marrow and organ function * Prior ADT: Participants must have started ADT at least 1 month (at least 28 days) but no more than 12 months before study entry and be willing to continue ADT during treatment * Prior taxane use for mHSPC is permitted: \~ Phase I and II: Participants may have received, but not progressed on, one prior taxane-based therapy. Phase II: Limited to 25% participants with prior taxane use. * Prior ARPI is allowed in both Phase I and Phase II: 1. Prior ARPI use in biochemical recurrence (BCR) or curative treatment is allowed for any duration, provided therapy was discontinued and participant had no evidence of conventional imaging positive metastatic disease at that time 2. Prior ARPI use in mHSPC is permitted but not mandated. - If participants meet all study eligibility criteria, they are required to stop their prior ARPI after providing informed consent and remain off ARPI until Cycle 1 Day 1, when study treatment is initiated. * Phase I: Allowed for any duration. * Phase II: Allowed prior exposure to ARPI is ≤4 months. * Phase II: Participants with ongoing use of darolutamide are not eligible. Participants with ongoing ARPI are eligible for a switch from their ongoing ARPI therapy if they have not progressed to CRPC disease, and meet any of the criteria, indicative of suboptimal biochemical response, or intolerability, as assessed by the Investigator. * Other permitted prior local therapy for mHSPC: * Phase I and II: Prior prostate-directed radiation or surgical intervention. Radiation must be completed before study entry; surgery at least 2 weeks prior. Key Exclusion Criteria: * 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 the start of study treatment. * Participants who have not received ARPI treatment for mHSPC and present with PSA levels of ≤0.5 ng/mL or those with prior/ongoing ARPI treatment presenting with PSA levels of ≤ 0.2 ng/mL prior to treatment assignment/randomization. * Participants with CNS metastases are excluded unless: * they have received prior therapy (e.g. surgery, radiotherapy, gamma knife), are neurologically stable and asymptomatic. * they are not receiving corticosteroid for the purpose of maintaining neurologic integrity and have baseline and subsequent radiological imaging of the brain. * Concurrent use of first-generation anti-androgens (like bicalutamide). Prior use of a first-generation anti-androgen drug in the context of ADT initiation with a GNRH analog is allowed, provided it was administered for ≤14 days and the last dose was administered ≥7 days from the study entry. * Systemic ketoconazole is used as antineoplastic treatment for prostate cancer. * Previous exposure to radioligand therapy. * Treatment with any investigational agent within 28 days (or 5 half-lives, whichever is longer) prior to study entry. * Previous treatment with any Polycomb Repressive Complex 2 (PRC2) inhibitor, including but not limited to Enhancer of Zeste Homolog 2 (EZH2) inhibitors, EZH2/1 inhibitors, or embryonic ectoderm development (EED) inhibitors. * Herbal products that may decrease PSA levels within 4 weeks prior to the start of study drug treatment and while on study. * Participants taking prohibited medication(s) (e.g., strong CYP3A4 inducers or strong or moderate CYP3A4 inhibitors that cannot be stopped within 7 days or 5 half-lives (whichever is longer) prior to study treatment and for the duration of the study treatment or prohibited herbal product(s) that cannot be stopped 7 days prior to study treatment. Other inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

Kennedy disease metastatic prostate carcinoma

As listed by the trial registrant

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

Metastatic hormone-sensitive prostate cancer (MHSPC)

How to take part

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

  1. The places running it

    30 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

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Medical University of South Carolina MUSC

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Novartis Investigative Site

    WITHDRAWN

    Camperdown, New South Wales, 2050, Australia

  • Novartis Investigative Site

    RECRUITING

    Wollongong, New South Wales, 2500, Australia

  • Novartis Investigative Site

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90610-001, Brazil

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H2X 1R9, Canada

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, 510060, China

  • Novartis Investigative Site

    RECRUITING

    Créteil, 94010, France

  • Novartis Investigative Site

    RECRUITING

    Lille, 59020, France

  • Novartis Investigative Site

    RECRUITING

    Nantes, 44093, France

  • Novartis Investigative Site

    RECRUITING

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    RECRUITING

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    RECRUITING

    Budapest, H 1122, Hungary

  • Novartis Investigative Site

    RECRUITING

    Budapest, H-1083, Hungary

  • Novartis Investigative Site

    RECRUITING

    Szeged, 6725, Hungary

  • Novartis Investigative Site

    RECRUITING

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    RECRUITING

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    RECRUITING

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28034, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28040, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28222, Spain

  • Novartis Investigative Site

    RECRUITING

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Uni Of Iowa Hospitals And Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Univ of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294-3300, United States

  • University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • Wichita Urology Group PA

    RECRUITING

    Wichita, Kansas, 67226, United States

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