TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination with Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination with Darolutamide Versus Darolutamide Alone in Patients with Metastatic Hormone Sensitive Prostate Cancer

Sponsor:

Novartis Corp.

Sponsor Study ID:

CDZR123C12101

CTO #:

104262

NCT Number:

NCT07190300

Phase:

I/II

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Prostate

Study Objectives:

Phase 1- Group A: To determine the RDE(s) of tulmimetostat in combination with darolutamide. Group B: To determine the RDE(s) of tulmimetostat in combination with abiraterone. Phase II- Group A: To determine the improvement in biochemical response rate (BCR) of tulmimetostat in combination with darolutamide compared to darolutamide alone.

eConsent:

Not available

Study Documents:

Open Study Documents
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