RecruitingPhase 1/2

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)

United States, Australia, Brazil181 participantsStarted 2026-01-13

Plain-language summary

The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase I (Group A and Group B): Dose-limiting toxicities (DLTs)

Timeframe: Up to 28 days

Phase I (Group A and Group B): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 79 months

Phase I (Group A and Group B): Number of Participants with dose adjustments

Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 79 months

Phase I (Group A and Group B): Dose Intensity

Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 79 months

Phase I (Group A and Group B): Duration of exposure to each study drug

Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 79 months

Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL

Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 79 months

Trial details

NCT IDNCT07190300

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2032-08-02

Contact for this trial

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

View on ClinicalTrials.gov More Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) trials

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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.

What they're measuring

Phase I (Group A and Group B): Dose-limiting toxicities (DLTs)

Timeframe: Up to 28 days

Phase I (Group A and Group B): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 79 months

Phase I (Group A and Group B): Number of Participants with dose adjustments

Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 79 months

Phase I (Group A and Group B): Dose Intensity

Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 79 months

Phase I (Group A and Group B): Duration of exposure to each study drug

Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 79 months

Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL

Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 79 months