TulmiSTAR-01: A Two-part, Phase I Dose Escalation and Expansion Followed by a Randomized, Open-label Multicenter, Phase II Study to Assess the Safety and Efficacy of the Combination of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) vs Standard of Care in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer

Interventions

• Drug
  Tulmimetostat DL1 QD

  Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

• Drug
  Tulmimetostat DL2 QD

  Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

• Drug
  Tulmimetostat DL3 QD

  Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

• Drug
  Tulmimetostat Doses 1 or 2 QD

  Part 1b (dose expansion and optimization): tulmimetostat doses 1 or 2 QD

• Drug
  Tulmimetostat RP2D QD

  Part 2: tulmimetostat Recommended Phase 2 Dose (RP2D) QD

• Drug
  JSB462 Dose 1 QD

  JSB462 Dose 1 QD

• Drug
  JSB462 Dose 2 QD

  JSB462 Dose 2 QD

• Drug
  JSB462 QD

  The dose of JSB462 QD will be determined based on the totality of data from Part 1a

• Drug
  Standard of Care (SoC)

  Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator

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