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Not yet recruitingLast updated: 1 May 2026

TulmiSTAR-02: Evaluating different combinations of treatment with tulmimetostat in people with hormone-sensitive prostate cancer that has spread (mHSPC)A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

TulmiSTAR-02

Clinical summary

Summary

This study is testing a new medicine caleld tulmimetostat to see if it is safe, what dose works best, and how well it treats people with prostate cancer that has spread but still response to hormone therapy.

Who is it for?
You may be eligible for this study if you have de novo or recurrent metastatic hormone-sensitive prostate cancer. You nust have started adrogen deprivation therapy at least 1 month but no more than 2 years before joining the study, and be willing to continue this. Other prior treatment hsitory criteria apply, speak with your doctor about whether you are eligible.

Study details
The study has two stages. In the first stage, small groups of participants receive tulmimetostat together with one of two standard hormone treatments (darolutamide or abiraterone) to find the safest and most effective dose combinations. Everyone continues standard hormone therapy to keep testosterone at very low levels, and those taking abiraterone also take a low-dose steroid as usual.

In the second stage, a larger group of participants is randomly assigned (by chance) to receive either tulmimetostat plus darolutamide or daralutamide alone, to see whether adding tulmimetostat helps control the cancer better and is safe.

The overall goal is to find out whether tulmimetostat, when combined with standard treatments, could be a new treatment option for people with metastatic hormone-sensitive prostate cancer.

The study for each participant consists of a screening period, a study treatment period followed by a post-treatment long-term follow-up.

Conditions

This trial is treating people with metastatic hormone-sensitive prostate cancer

Eligibility

Inclusion

  • 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 but no more than 24 months before study entry and be willing to continue ADT during treatment

  • Prior taxane use for mHSPC:

    ~ 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 (abiraterone, enzalutamide, darolutamide, or apalutamide) 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

      • Phase I: Allowed for any duration.
      • Phase II: Allowed prior exposure to ARPI is ≤6 months. Participants with ongoing use of darolutamide are not eligible.

      Note: Participants are required to stop their prior ARPI after providing their consent to join this study. 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.

Exclusion

  • 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 with PSA levels of ≤ 0.2 ng/mL at the start of study treatment.

  • 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.
    • Participants with epidural disease, canal disease, or prior spinal cord involvement are excluded unless these areas have been treated, are stable, and the participant is not neurologically impaired.
  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You are currently receiving treatment for your cancer.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer

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