At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tulmimetostat (drug), Darolutamide (drug), Abiraterone (drug), Prednisone/Prednisolone (drug)
- How long the study runs
- Study runs about 79 months (dates as stated)
- About the drug or intervention
- Tulmimetostat — drug: Tulmimetostat is an oral dual EZH1/EZH2 inhibitor administered once daily. · Darolutamide — drug: Darolutamide 600 mg administered orally twice daily (BID). · Abiraterone — drug: Abiraterone 1000 mg administered orally once daily (QD) in combination with prednisone/prednisolone according to local prescribing information. · Prednisone/Prednisolone — drug: Oral corticosteroid administered with abiraterone in Phase I Group B according to local prescribing information. · Androgen Deprivation Therapy (ADT) — drug: Background therapy consisting of a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior orchiectomy to maintain castrate testosterone levels (\<50 ng/dL \[\<1.7 nmol/L\]).
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 181
- Started
- 2026-01-13
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic hormone-sensitive prostate cancer (mhspc)
- • Phase1/Phase2 - 181 participants
- • The purpose of this study is to evaluate the safety, tolerability, and efficacy of two different treatment combinations of tulmimetostat in participants with de novo or recurrent metastatic hormone-sensitive prostate cancer (mHSPC)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic hormone-sensitive prostate cancer (mhspc)
- • Male only
Where?
- • London - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the safety, tolerability, and efficacy of two different treatment combinations of tulmimetostat in participants with de novo or recurrent metastatic hormone-sensitive prostate cancer (mHSPC). Phase I aims to determine the recommended dose(s) for expansion (RDE) of tulmimetostat in combination with darolutamide or abiraterone. Phase II is designed to further evaluate the efficacy and safety of tulmimetostat in combination with darolutamide compared with darolutamide alone in participants with mHSPC.
More detail
This is a Phase I/II, open-label, global, multicenter study evaluating tulmimetostat in combination with androgen receptor pathway inhibitors in participants with de novo or recurrent metastatic hormone-sensitive prostate cancer (mHSPC). The study consists of two phases: Phase I (Dose Escalation) Phase I includes two treatment groups: 1. Group A (Part 1): tulmimetostat in combination with darolutamide. 2. Group B (Part 2): tulmimetostat in combination with abiraterone. The primary objective of Phase I is to determine the recommended dose(s) for expansion (RDE) of tulmimetostat in each combination regimen through a parallel dose-escalation design guided by a Bayesian Logistic Regression Model (BLRM). Enrollment will follow a staggered approach between the two groups. Participants may have received prior taxane-based chemotherapy and/or prior androgen receptor pathway inhibitor (ARPI) therapy and must not have received prior radioligand therapy. Participants will continue androgen deprivation therapy (ADT) to maintain castrate testosterone levels (\<50 ng/dL or \<1.7 nmol/L) according to investigator choice and local prescribing information. In Group B, abiraterone will be administered with prednisone or prednisolone according to local prescribing information. Phase II (Dose Expansion) Phase II is a randomized, open-label, multicenter dose-expansion study designed to further characterize the recommended dose(s) of tulmimetostat in combination with darolutamide and to provide proof-of-concept for the efficacy and safety of tulmimetostat plus darolutamide compared with darolutamide alone. Eligible participants are adult men with de novo or recurrent mHSPC who have not received prior radioligand therapy and may have received prior taxane-based chemotherapy and/or prior ARPI therapy (excluding darolutamide), with a maximum prior ARPI exposure of 4 months in the mHSPC setting. Participants will continue ADT throughout the study according to investigator choice and local prescribing information. Based on Phase I results, one or two tulmimetostat dose levels in combination with darolutamide may be evaluated. Study Duration and Follow-up For each participant, the study consists of a screening period, a treatment period, and post-treatment follow-up. Post-treatment follow-up includes: 1. A 30-day safety follow-up visit after permanent discontinuation of study treatment. 2. An efficacy follow-up period for participants who discontinue study treatment without documented disease progression or initiation of new anti-neoplastic therapy, including scheduled imaging assessments. 3. Long-term follow-up to collect survival status, new anti-neoplastic therapies, suspected treatment-related serious adverse events, and second primary malignancies. Participants will be contacted approximately every 12 weeks during the first 3 years and every 24 weeks thereafter until death, loss to follow-up, or withdrawal of consent. The study is designed to evaluate whether inhibition of EZH1/2 with tulmimetostat in combination with androgen receptor pathway inhibition may improve clinical outcomes in men with metastatic hormone-sensitive prostate cancer.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ castrate levels of testosterone, i
- ✓ started ADT at least 1 month (at least 28 days) but no more than 12 months
What the study is looking for
- ✓Adult men ≥ 18 years old with de novo or recurrent mHSPC (without neuroendocrine or small cell features). The tumor...
- ✓Participants must have castrate levels of testosterone, i.e., ≤ 50 ng/dL (≤ 1.7 nM).
- ✓activity scale (ECOG) performance status 0 to 2
- ✓Adequate bone marrow and organ health
- ✓Prior ADT: Participants must have started ADT at least 1 month (at least 28 days) but no more than 12 months before...
Who cannot take part
- ✗Participants with CNS metastases are excluded unless:
- ✗they have received prior therapy (e.g. surgery, radiotherapy, gamma knife), are neurologically stable and not causing symptoms.
- ✗they are not receiving corticosteroid for the purpose of maintaining neurologic integrity and have baseline and...
- ✗Systemic ketoconazole is used as antineoplastic treatment for prostate cancer.
- ✗Previous exposure to radioligand therapy.
See the full criteria
Where Is This Study? (1 UK site)
Novartis Investigative Site
London W1G 6AD, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT
