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)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

November 28, 2025

Primary Completion Date

October 29, 2029

Study Completion Date

December 17, 2030

Conditions
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

Trial Locations (2)

2065

RECRUITING

Novartis Investigative Site, St Leonards

S308433

RECRUITING

Novartis Investigative Site, Singapore

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY