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)

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

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

  Measured over: From the first dose of study treatment through the end of Cycle 1, up to 28 days

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

  Measured over: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months

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

  Measured over: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months

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

  Measured over: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months

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

  Measured over: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months

• Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL at Month 6

  Measured over: At Month 6, with confirmation by a second prostate-specific antigen assessment performed at least 3 weeks later

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