This is a two-part, Phase I/II, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with progressive metastatic castrate resistant prostate cancer (mCRPC).
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Part 1a: Dose-limiting toxicities (DLTs)
Timeframe: Up to 28 days
Part 1a and Part 1b: 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 14 months
Part 1a and Part 1b: Number of Participants with dose adjustments
Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 14 months
Part 1a and Part 1b: Dose Intensity
Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 14 months
Part 1a and Part 1b: Duration of exposure to each study drug
Timeframe: From date of randomization till 30 days safety fup, assessed up to approximately 14 months
Part 1b and Part 2: prostate-specific antigen 50 (PSA50) at Month 6
Timeframe: Month 6