Tulmimetostat + Darolutamide/Abiraterone for Prostate Cancer
(TulmiSTAR-02 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety and effectiveness of two drug combinations for treating metastatic hormone-sensitive prostate cancer (mHSPC), which is prostate cancer that has spread but still responds to hormone therapy. Participants will receive tulmimetostat (an experimental treatment) with either Abiraterone or Darolutamide to evaluate the effectiveness of these combinations. Men diagnosed with mHSPC, who have at least one metastatic lesion and are already on hormone therapy, might be suitable for this study. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants the opportunity to contribute to groundbreaking advancements in prostate cancer treatment.
Do I need to stop taking my current medications to join the trial?
The trial requires that you stop taking certain medications, such as first-generation anti-androgens and systemic ketoconazole, before joining. Herbal products that may lower PSA levels must also be stopped 4 weeks before starting the study treatment. If you're taking any prohibited medications, you need to stop them 7 days before the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that darolutamide helps patients with prostate cancer live longer, with side effects similar to those of a placebo, indicating it is generally well-tolerated. Abiraterone, already approved for prostate cancer, has been extensively studied. Research has shown it is safe, though some patients may experience side effects like high blood pressure or changes in liver function.
Tulmimetostat has been less studied, but ongoing research is examining its safety. Since this trial is in its early stages (Phase 1/2), researchers are beginning to understand its safety profile. Early-phase trials typically focus on safety and determining the right dose, so while detailed safety data is not yet available, the treatment is being carefully tested for safety in humans.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Tulmimetostat with Darolutamide or Abiraterone for prostate cancer because it brings a fresh approach to treatment. Unlike most treatments that target androgen receptors, Tulmimetostat is a novel drug that potentially inhibits cancer growth by modifying gene expression through epigenetic changes. This unique mechanism could offer an alternative pathway to tackling cancer cells, especially when combined with the well-established hormone therapies, Darolutamide and Abiraterone. The combination therapies might enhance effectiveness and possibly delay resistance, offering hope for improved outcomes in prostate cancer management.
What evidence suggests that this trial's treatments could be effective for metastatic hormone-sensitive prostate cancer?
Research has shown that darolutamide, when used for prostate cancer, reduces the risk of death by 32.5% and improves survival rates compared to a placebo. Abiraterone also extends patients' lives and slows disease progression in similar groups. Tulmimetostat targets specific cancer pathways, but earlier studies in prostate cancer showed no responses. In this trial, some participants will receive a combination of tulmimetostat with darolutamide, while others will receive tulmimetostat with abiraterone. Researchers are further studying these combinations to confirm their potential benefits in overcoming common resistance in prostate cancer treatment.12367
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Participants receive tulmimetostat in combination with darolutamide or abiraterone to determine the Recommended Dose Escalations (RDEs)
Phase II Treatment
Randomized, open-label study to evaluate the recommended dose(s) of tulmimetostat in combination with darolutamide versus darolutamide alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
5
Treatment groups
Experimental Treatment
Active Control
Tulmimetostat dose 2 PO + Darolutamide 600 mg PO BID
Tulmimetostat dose 1 PO + Darolutamide 600 mg PO BID
Tulmimetostat PO QD escalating doses + Abiraterone 1000 mg PO QD
Tulmimetostat oral (PO) once a day (QD) escalating doses + Darolutamide 600 mg twice a day (BID)
Darolutamide 600 mg PO BID
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
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
Citations
Study Details | NCT07190300 | TulmiSTAR-02: A Phase I/II ...
The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in ...
A Phase I/II Open-label Study of Tulmimetostat in ...
The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in ...
Clinical outcomes in metastatic prostate adenocarcinoma ...
The findings suggest that both abiraterone and enzalutamide are effective in prolonging progression-free and overall survival in this patient population.
EZH2 Inhibition for Prostate Cancer; It's Taken Awhile, but ...
Tulmimetostat was tested in a phase 2 trial and it unfortunately yielded zero responses in prostate cancer. A phase 1/2 trial of SHR2554 ...
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients ...
Tulmimetostat will be dosed once per day orally in combination with enzalutamide Cohort M8 patients with castration-resistant prostate cancer (mCRPC).
The Safety of Abiraterone Acetate in Patients with Metastatic ...
This study seeks to describe the safety determined in randomized clinical trials of a systemic treatment for mCRPC and whether safety differs by ...
ANZCTR - Registration
TulmiSTAR-01: A Two-part, Phase I Dose Escalation and Expansion Followed by a Randomized, Open-label Multicenter, Phase II Study to Assess ...
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