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).
Participant is an adult man ≥ 18 years of age.
Participant must have histologically and/or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell features (current or prior biopsy of the prostate and/or metastatic site).
Participant must have ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to start of treatment (Part 1a dose escalation) or randomization (Part 1b dose expansion and Part 2).
Participant must have progressive mCRPC.
Previous treatment with any PRC2 inhibitor, including but not limited to EZH2 inhibitors, EZH2/1 inhibitors, or embryonic ectoderm development (EED) inhibitors.
Previous treatment with a protein degrader compound that targets the AR.
Known hypersensitivity or contraindication to any of the study treatment components or its excipients or to drugs of similar chemical classes.
Treatment with any investigational agent within 28 days (or 5 half-lives, whichever is longer) prior to study entry.
10
Treatment groupsSee each treatment group below.