Tulmimetostat + Darolutamide/Abiraterone for Prostate Cancer

(TulmiSTAR-02 Trial)

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Novartis Pharmaceuticals

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

203 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

Men over 18 with metastatic hormone-sensitive prostate cancer, either new or recurrent, can join this trial. They must have low testosterone levels and a performance status showing they can handle daily activities. Participants should not have progressed on prior taxane-based therapy or be currently using darolutamide but may have used similar drugs for less than six months.

Inclusion Criteria

My organs and bone marrow are working well.

I've used ARPI for prostate cancer before but stopped when there was no sign of spread on scans.

I have used ARPI for my metastatic hormone-sensitive prostate cancer.

What Are the Treatments Tested in This Trial?

Interventions

• Abiraterone
• Darolutamide
• Tulmimetostat

Trial Overview The TulmiSTAR-02 study is testing how safe and effective it is to combine Tulmimetostat with Darolutamide versus just Darolutamide alone, as well as combining Tulmimetostat with Abiraterone in treating advanced prostate cancer that responds to hormonal therapy.

How Is the Trial Designed?

Group I: Phase II: Arm 2 Experimental Treatment 2 Interventions

Tulmimetostat dose 2 PO + Darolutamide 600 mg PO BID

Group II: Phase II: Arm 1 Experimental Treatment 2 Interventions

Tulmimetostat dose 1 PO + Darolutamide 600 mg PO BID

Group III: Phase I: Group B (part 2) Experimental Treatment 2 Interventions

Tulmimetostat PO QD escalating doses + Abiraterone 1000 mg PO QD

Group IV: Phase I: Group A (part 1) Experimental Treatment 2 Interventions

Tulmimetostat oral (PO) once a day (QD) escalating doses + Darolutamide 600 mg twice a day (BID)

Group V: Phase II: Arm 3 Active Control 1 Intervention

Darolutamide 600 mg PO BID

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD