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Tulmimetostat Combinations for Metastatic Hormone-Sensitive Prostate Cancer

This study is testing new combinations of medicines for men with metastatic hormone-sensitive prostate cancer (mHSPC), which is prostate cancer that has spread to other parts of the body and still responds to hormone therapy. The study is looking at how safe and effective two combinations are: tulmimetostat with darolutamide, and tulmimetostat with abiraterone. You might be able to join if you are an adult man (18 years or older) with mHSPC that is either new or has come back, and your testosterone levels are low (castrate levels). The main goals are to find the safest doses of these combinations and to see how well they work. The study plans to enroll 181 participants, but the current recruitment status is unclear.

Study design
This is an interventional study with two phases. Phase I will determine safe doses of tulmimetostat with darolutamide or abiraterone. Phase II will compare tulmimetostat plus darolutamide to darolutamide alone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be assessed for up to 30 days after treatment, with overall follow-up for adverse events extending up to approximately 79 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07190300

TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~181 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:TulmimetostatDarolutamideAbiraterone

At a glance

Recruiting sites
30 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I (Group A and Group B): Dose-limiting toxicities (DLTs)
Measured over Up to 28 days
+5 more outcomes measured

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Explore related trials

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Where it's being run

31 sites across 21 states
France3
Hungary3
Spain3
Kansas2
South Carolina2
New South Wales2
South Korea2
Alabama1

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Eligibility criteria

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 (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:
Prior ARPI is allowed in both Phase I and Phase II:
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.

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 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.

What this trial measures

  • Phase I (Group A and Group B): Dose-limiting toxicities (DLTs)Up to 28 days

    A dose-limiting toxicity is defined as an adverse event or abnormal laboratory value, not clearly due to underlying disease or extraneous causes, that occurs within the first 28 days of treatment with tulmimetostat and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. For the purpose of dose-escalation decisions, DLTs will be considered and included in the Bayesian Logistic Regression Model (BLRM).

  • Phase I (Group A and Group B): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)From date of randomization till 30 days safety fup, assessed up to approximately 79 months

    The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.

  • Phase I (Group A and Group B): Number of Participants with dose adjustmentsFrom date of randomization till 30 days safety fup, assessed up to approximately 79 months

    The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.

  • Phase I (Group A and Group B): Dose IntensityFrom date of randomization till 30 days safety fup, assessed up to approximately 79 months

    Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity) will be summarized by means of descriptive statistics

  • Phase I (Group A and Group B): Duration of exposure to each study drugFrom date of randomization till 30 days safety fup, assessed up to approximately 79 months

    Duration of exposure (in months) to each study drug will be summarized by means of descriptive statistics

  • Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mLFrom date of randomization till 30 days safety fup, assessed up to approximately 79 months

    Prostate-Specific Antigen (PSA) response rate is defined as proportion of participants who achieved a decline in PSA to \< 0.2 ng/mL at month 6 months, confirmed by a second PSA measurement ≥ 3 weeks later.