drugset / Trial / NCT07206056

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)

NCT07206056

Phase 1/2 Recruiting 188 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2025-10-15
Primary completion
2029-11-09
Completion
2030-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Luxdegalutamide Small molecule
Subject Tulmimetostat Small molecule
Comparator 177Lu-PSMA-617 Other / unclassified