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TulmiSTAR-02: 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)
EU CTIS ID: 2025-521873-15-00
What this study is testing
Phase I : To determine the Recommended Dose(s) for Expansion (RDE(s) of tulmimetostat in combination with darolutamide and tulmimetostat in combination with abiraterone Phase II: To determine the improvement in biochemical response rate (BCR) of tulmimetostat in combination with darolutamide compared to darolutamide alone
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult men ≥ 18 years old with de novo or recurrent mHSPC (without neuroendocrine or small cell features), with at least one documented metastatic lesion. This lesion 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 androgen deprivation therapy (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
You likely can't join if
- 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 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.
- Participants with PSA levels of ≤ 0.2 ng/mL at the start of study treatment
- Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), are asymptomatic and neurologically stable without corticosteroids. Baseline and subsequent radiological imaging for them must include evaluation 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.
See the full eligibility criteria
Who can join
- Adult men ≥ 18 years old with de novo or recurrent mHSPC (without neuroendocrine or small cell features), with at least one documented metastatic lesion. This lesion 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 androgen deprivation therapy (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: a. 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 b. 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.
- Phase I and II: Prior prostate-directed radiation or surgical intervention. Radiation must be completed before study entry; surgery at least 2 weeks prior.
What rules you out
- 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 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.
- Participants with PSA levels of ≤ 0.2 ng/mL at the start of study treatment
- Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), are asymptomatic and neurologically stable without corticosteroids. Baseline and subsequent radiological imaging for them must include evaluation 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
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- China
- Japan
- Brazil
- United Kingdom
- Turkey
- Korea, Republic of
- Hong Kong
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; China; Japan; Brazil; United Kingdom; Turkey and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.