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)
Part of paid clinical trials in Denver, Colorado.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07206056
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Progressive Metastatic Castrate Resistant Prostate Cancer
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tulmimetostat DL1 QD — DRUGPart 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))
- Tulmimetostat DL2 QD — DRUGPart 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))
- Tulmimetostat DL3 QD — DRUGPart 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))
- Tulmimetostat Doses 1 or 2 QD — DRUGPart 1b (dose expansion and optimization): tulmimetostat doses 1 or 2 QD
- Tulmimetostat RP2D QD — DRUGPart 2: tulmimetostat Recommended Phase 2 Dose (RP2D) QD
- JSB462 Dose 1 QD — DRUGJSB462 Dose 1 QD
- JSB462 Dose 2 QD — DRUGJSB462 Dose 2 QD
- JSB462 QD — DRUGThe dose of JSB462 QD will be determined based on the totality of data from Part 1a
- Standard of Care (SoC) — DRUGAndrogen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator
Study Details
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).
Key Dates
- Start date
- Oct 15, 2025
- Status verified
- Jun 2026
- Primary completion
- Nov 9, 2029
- Completion
- Dec 1, 2030
Study Design
- Enrollment
- 188 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1a: Cohort DL1ATulmimetostat DL1 QD + JSB462 Dose 1 QD
- Experimental: Part 1a: Cohort DL1BTulmimetostat DL1 QD + JSB462 Dose 2 QD
- Experimental: Part 1a: Cohort DL2ATulmimetostat DL2 QD + JSB462 Dose 1 QD
- Experimental: Part 1a: Cohort DL2BTulmimetostat DL2 QD + JSB462 Dose 2 QD
- Experimental: Part 1a: Cohort DL3ATulmimetostat DL3 QD + JSB462 Dose 1 QD
- Experimental: Part 1a: Cohort DL3BTulmimetostat DL3 QD + JSB462 Dose 2 QD
- Experimental: Part 1b : Arm ATulmimetostat Dose 1 QD + JSB462 QD
- Experimental: Part 1b: Arm BTulmimetostat Dose 2 QD + JSB462 QD
- Experimental: Part 2: Arm 1Tulmimetostat RP2D QD + JSB462 QD
- Active Comparator: Part 2: Arm 2Standard of Care at the discretion of the investigator
Primary Outcome Measure
Part 1a: Dose-limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | Gerald Falchook (PRINCIPAL_INVESTIGATOR) |
| Sarah Cannon Research Institute | Jacksonville | Florida | 32256 | Kandyce Trejo Manish Patel (PRINCIPAL_INVESTIGATOR) |
| Emory University | Atlanta | Georgia | 30329 | Wilena Session Jacqueline Brown (PRINCIPAL_INVESTIGATOR) |
| Wichita Urology Group PA | Wichita | Kansas | 67226 | Tyler Gentry Timothy Richardson (PRINCIPAL_INVESTIGATOR) |
| Mass General Hospital | Boston | Massachusetts | 02114 | Manda Ngin Xin Gao (PRINCIPAL_INVESTIGATOR) |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | Michael Schweizer (PRINCIPAL_INVESTIGATOR) |