An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)

Study Summary

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).

Conditions

Progressive Metastatic Castrate Resistant Prostate Cancer

Interventions / Drugs

Tulmimetostat DL1 QD Tulmimetostat DL2 QD Tulmimetostat DL3 QD Tulmimetostat Doses 1 or 2 QD Tulmimetostat RP2D QD JSB462 Dose 1 QD JSB462 Dose 2 QD JSB462 QD Standard of Care (SoC)

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment188 participants

Primary Completion—

Lead SponsorNovartis Pharmaceuticals

Data Retrieved2026-04-11 02:55:49.152798+00:00

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