Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Phase 1/2TulmiSTAR-02NCT07190300
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
A Phase 1/2 study testing Tulmimetostat, Darolutamide and Abiraterone in people with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by Novartis Pharmaceuticals at 31 sites in 14 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- What is being tested?
- Tulmimetostat, Darolutamide and Abiraterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 31 sitesin 14 countries
- Study dates
- 13 Jan 2026to 2 Aug 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men ≥ 18 years old with de novo or recurrent mHSPC (without neuroendocrine or small cell features). The tumor lesion(s) may be located in the bone, soft tissue/visceral region, or both.
- Participants must have castrate levels of testosterone, i.e., ≤ 50 ng/dL (≤ 1.7 nM).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate bone marrow and organ function
- Prior ADT: Participants must have started ADT at least 1 month (at least 28 days) but no more than 12 months before study entry and be willing to continue ADT during treatment
- Prior taxane use for mHSPC is permitted:
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- Phase I and II: Participants may have received, but not progressed on, one prior taxane-based therapy.
- Phase II: Limited to 25% participants with prior taxane use.
- Prior ARPI is allowed in both Phase I and Phase II:
- Prior ARPI use in biochemical recurrence (BCR) or curative treatment is allowed for any duration, provided therapy was discontinued and participant had no evidence of conventional imaging positive metastatic disease at that time
- Prior ARPI use in mHSPC is permitted but not mandated. If participants meet all study eligibility criteria, they are required to stop their prior ARPI after providing informed consent and remain off ARPI until Cycle 1 Day 1, when study treatment is initiated.
- Phase I: Allowed for any duration.
- Phase II: Allowed prior exposure to ARPI is ≤4 months. Participants with ongoing use of darolutamide are not eligible.
- Participants with ongoing ARPI are eligible for a switch from their ongoing ARPI therapy if they have not progressed to CRPC disease, and meet any of the criteria, indicative of suboptimal biochemical response, or intolerability, as assessed by the Investigator:
- Evidence of insufficient PSA control or suboptimal PSA response, defined as PSA ≥ 0.2 ng/mL after 6-12 months ADT and no more than 4 months of current ARPI therapy in mHSPC with declining or stable PSA trend. Eligibility based on biochemical progression should be supported by objective evidence (e.g. PSA results).
- Intolerance and non-compliance: Participant's inability to tolerate or comply with the prescribed ARPI. The site should maintain documentation to support the appropriateness of therapy changes resulting from intolerance or non-compliance.
- Other permitted prior local therapy for mHSPC:
- Phase I and II: Prior prostate-directed radiation or surgical intervention. Radiation must be completed before study entry; surgery at least 2 weeks prior.
Who cannot join
- Participants with evidence of mCRPC or biochemical recurrence / PSA only disease or asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy and with normal PSA for ≥ 1 year prior to the start of study treatment.
- Participants who have not received ARPI treatment for mHSPC and present with PSA levels of ≤0.5 ng/mL or those with prior/ongoing ARPI treatment presenting with PSA levels of ≤ 0.2 ng/mL prior to treatment assignment/randomization.
- Participants with CNS metastases are excluded unless:
- they have received prior therapy (e.g. surgery, radiotherapy, gamma knife), are neurologically stable and asymptomatic.
- they are not receiving corticosteroid for the purpose of maintaining neurologic integrity and have baseline and subsequent radiological imaging of the brain.
- Concurrent use of first-generation anti-androgens (like bicalutamide). Prior use of a first-generation anti-androgen drug in the context of ADT initiation with a GNRH analog is allowed, provided it was administered for ≤14 days and the last dose was administered ≥7 days from the study entry.
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- Systemic ketoconazole is used as antineoplastic treatment for prostate cancer.
- Previous exposure to radioligand therapy.
- Treatment with any investigational agent within 28 days (or 5 half-lives, whichever is longer) prior to study entry.
- Previous treatment with any Polycomb Repressive Complex 2 (PRC2) inhibitor, including but not limited to Enhancer of Zeste Homolog 2 (EZH2) inhibitors, EZH2/1 inhibitors, or embryonic ectoderm development (EED) inhibitors.
- Herbal products that may decrease PSA levels within 4 weeks prior to the start of study drug treatment and while on study.
- Participants taking prohibited medication(s) (e.g., strong CYP3A4 inducers or strong or moderate CYP3A4 inhibitors that cannot be stopped within 7 days or 5 half-lives (whichever is longer) prior to study treatment and for the duration of the study treatment or prohibited herbal product(s) that cannot be stopped 7 days prior to study treatment.
- Have a history of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 3 years. Participants with a history of leukemia/lymphoma and/or MDS are not eligible.
- Other inclusion/exclusion criteria may apply
Trial locations and contacts
31 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 14 countries
United States8 sites, 8 recruiting
- Recruiting
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Luke Hanna, lukehanna@uabmc.edu
Joelle Hamilton
- Recruiting
Medical University of South Carolina MUSC
Charleston, South Carolina, 29425
Renee Tucker, 843-792-7560, tuckerr@musc.edu
Kevin Becker
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Tykeytra Dale, tykeytra.dale@duke.edu
Jeffrey Shevach
- Recruiting
Uni Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
Kerri Fitch, kerri-fitch@uiowa.edu
Fernando Maciel Barbosa
- Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Lindsey Rabon, 843-839-1679, lindsey.rabon@startresearch.com
Neal Shore
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Alena Turner, alena.turner@hci.utah.edu
Neeraj Agarwal
- Recruiting
University of Kansas Cancer Center
Westwood, Kansas, 66205
Katie Looney, klooney2@kumc.edu
Haoran Li
- Recruiting
Wichita Urology Group PA
Wichita, Kansas, 67226
Tyler Gentry, tgentry@wichitaurology.com
Timothy Richardson
France3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Créteil, 94010
- Recruiting
Novartis Investigative Site
Lille, 59020
- Recruiting
Novartis Investigative Site
Nantes, 44093
Hungary3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Budapest, 1083
- Recruiting
Novartis Investigative Site
Budapest, 1122
- Recruiting
Novartis Investigative Site
Szeged, 6725
Spain3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Madrid, 28034
- Recruiting
Novartis Investigative Site
Madrid, 28040
- Recruiting
Novartis Investigative Site
Madrid, 28222
Australia2 sites, 1 recruiting
- Withdrawn
Novartis Investigative Site
Camperdown, New South Wales, 2050
- Recruiting
Novartis Investigative Site
Wollongong, New South Wales, 2500
Germany2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Essen, 45147
- Recruiting
Novartis Investigative Site
Jena, Thuringia, 07740
Italy2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Rozzano, MI, 20089
- Recruiting
Novartis Investigative Site
Verona, VR, 37134
South Korea2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Seoul, 05505
- Recruiting
Novartis Investigative Site
Seoul, 06591
Brazil1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90610-001
Canada1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H2X 1R9
China1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Guangzhou, 510060
Hong Kong1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Hong Kong, 999077
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Ankara, Sihhiye Altindag, 06230
United Kingdom1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
London, W1G 6AD
About this study
Official title: TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer
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.
Read the detailed description
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:
- Group A (Part 1): tulmimetostat in combination with darolutamide.
- 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:
- A 30-day safety follow-up visit after permanent discontinuation of study treatment.
- 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.
- 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.
- Being tested
- Tulmimetostat, Darolutamide, Abiraterone, Prednisone/Prednisolone, Androgen Deprivation Therapy (ADT)
- Keywords
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), Enhancer of Zeste Homolog 2 (EZH2), Androgen Receptor (AR), Androgen Receptor Pathway Inhibitors (ARPIs), Prostate-Specific Antigen (PSA), PSA Response Rate, TulmiSTAR-02, Tulmimetostat (DZR123), Darolutamide, Abiraterone
- Medical subject headings
- Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TulmimetostatDrug
Also called DZR123
Tulmimetostat is an oral dual EZH1/EZH2 inhibitor administered once daily. In Phase I, escalating dose levels will be evaluated in combination with darolutamide or abiraterone. In Phase II, one or two dose levels selected from Phase I will be evaluated in combination with darolutamide.
DarolutamideDrug
Darolutamide 600 mg administered orally twice daily (BID).
AbirateroneDrug
Abiraterone 1000 mg administered orally once daily (QD) in combination with prednisone/prednisolone according to local prescribing information.
Prednisone/PrednisoloneDrug
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]). All participants will continue ADT throughout study participation.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Group A (part 1) | Experimental | Tulmimetostat administered orally once daily (QD) at escalating dose levels in combination with darolutamide 600 mg orally twice daily (BID). Participants will continue androgen deprivation therapy (ADT) throughout the study. Receives: Drug: Tulmimetostat; Drug: Darolutamide; Drug: Androgen Deprivation Therapy (ADT) |
| Phase I: Group B (part 2) | Experimental | Tulmimetostat administered orally once daily (QD) at escalating dose levels in combination with abiraterone 1000 mg orally once daily (QD). Participants will continue androgen deprivation therapy (ADT). Abiraterone will be administered with prednisone/prednisolone according to local prescribing information. Receives: Drug: Tulmimetostat; Drug: Abiraterone; Drug: Prednisone/Prednisolone; Drug: Androgen Deprivation Therapy (ADT) |
| Phase II: Arm 1 | Experimental | Tulmimetostat Dose 1 orally once daily (QD) in combination with darolutamide 600 mg orally twice daily (BID). Participants will continue androgen deprivation therapy (ADT). Receives: Drug: Tulmimetostat; Drug: Darolutamide; Drug: Androgen Deprivation Therapy (ADT) |
| Phase II: Arm 2 (Optional) | Experimental | Tulmimetostat Dose 2 orally once daily (QD) in combination with darolutamide 600 mg orally twice daily (BID). Participants will continue androgen deprivation therapy (ADT). This arm will be included if two recommended dose(s) for expansion are selected from Phase I. Receives: Drug: Tulmimetostat; Drug: Darolutamide; Drug: Androgen Deprivation Therapy (ADT) |
| Phase II: Arm 3 (Control) | Active comparator | Darolutamide 600 mg orally twice daily (BID). Participants will continue androgen deprivation therapy (ADT). Receives: Drug: Darolutamide; Drug: Androgen Deprivation Therapy (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I (Group A and Group B): Dose-limiting toxicities (DLTs)
A dose-limiting toxicity was defined as an adverse event or abnormal laboratory value that was not clearly attributable to the underlying disease or an extraneous cause, occurred during the first 28 days of treatment with tulmimetostat, and met the protocol-defined dose-limiting toxicity criteria. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Dose-limiting toxicities were included in the Bayesian Logistic Regression Model used to support dose-escalation decisions.
Measured: From the first dose of study treatment through the end of Cycle 1, up to 28 days
Phase I (Group A and Group B): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The incidence, type, frequency, seriousness, and severity of adverse events and serious adverse events will be summarized. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
Measured: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase I (Group A and Group B): Number of Participants with dose adjustments
The number of participants with dose reductions, dose interruptions, or permanent discontinuations, including the reasons for the dose adjustments, will be summarized by treatment group and dose cohort.
Measured: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase I (Group A and Group B): Dose Intensity
Dose intensity, calculated as the actual cumulative dose received divided by the actual duration of exposure, and relative dose intensity, calculated as the dose intensity divided by the planned dose intensity, will be summarized using descriptive statistics for each study drug.
Measured: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase I (Group A and Group B): Duration of exposure to each study drug
The duration of exposure, in months, to each study drug will be summarized using descriptive statistics by treatment group and dose cohort.
Measured: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL at Month 6
Prostate-Specific Antigen (PSA) response rate is defined as the proportion of participants who achieved a prostate-specific antigen level below 0.2 ng/mL at Month 6, confirmed by a second prostate-specific antigen assessment performed at least 3 weeks later.
Measured: At Month 6, with confirmation by a second prostate-specific antigen assessment performed at least 3 weeks later
Secondary outcomes (21)
Phase I (Group A): Plasma concentrations of Tulmimetostat and Darolutamide
Plasma concentrations of tulmimetostat and darolutamide will be evaluated using pharmacokinetic samples collected from participants across the evaluated dose levels in Phase I, Group A.
Measured: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days
Phase I (Group A): AUC of Tulmimetostat and Darolutamide
The area under the concentration-time curve from time zero to the last quantifiable concentration, the area under the concentration-time curve from time zero extrapolated to infinity, and the area under the concentration-time curve over a dosing interval at steady state will be derived, as applicable, and summarized using descriptive statistics.
Measured: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days
Phase I (Group A): Maximum Observed Plasma Concentration (Cmax) of Tulmimetostat and Darolutamide
The maximum observed plasma concentration of tulmimetostat and darolutamide will be derived, as applicable, and summarized using descriptive statistics.
Measured: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days
Phase I (Group B): Plasma concentrations of Tulmimetostat and Abiraterone
Plasma concentrations of tulmimetostat and abiraterone will be evaluated using pharmacokinetic samples collected from participants across the evaluated dose levels in Phase I, Group B.
Measured: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Day 2: 0 and 24 hours post-dose; Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days.
Phase I (Group B): AUC of Tulmimetostat and Abiraterone
The area under the concentration-time curve from time zero to the last quantifiable concentration, the area under the concentration-time curve from time zero extrapolated to infinity, and the area under the concentration-time curve over a dosing interval at steady state will be derived, as applicable, and summarized using descriptive statistics.
Measured: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Day 2: 0 and 24 hours post-dose; Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days.
Phase I (Group B): Maximum Observed Plasma Concentration (Cmax) of Tulmimetostat and Abiraterone
The maximum observed plasma concentration of tulmimetostat and abiraterone will be derived, as applicable, and summarized using descriptive statistics.
Measured: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Day 2: 0 and 24 hours post-dose; Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days.
Phase II (Group A): Radiographic progression free survival (rPFS)
Radiographic progression free survival (rPFS) is defined as the time from randomization to the first documented disease progression according to Prostate Cancer Working Group 3-modified Response Evaluation Criteria in Solid Tumors, version 1.1, as assessed by the investigator, or death from any cause, whichever occurred first.
Measured: From randomization until the first documented radiographic disease progression or death from any cause, whichever occurs first, assessed up to approximately 79 months
Phase II (Group A):Overall survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause.
Measured: From randomization until death from any cause, assessed up to approximately 79 months
Phase II (Group A): Objective Response Rate (ORR)
Objective response (OR) is defined as the proportion of participants with a best overall response of confirmed complete response or partial response according to Prostate Cancer Working Group 3-modified Response Evaluation Criteria in Solid Tumors, version 1.1, as assessed by the investigator.
Measured: From randomization until disease progression, death, or the last adequate tumor assessment, assessed up to approximately 79 months
Phase II (Group A): Best Overall Response (BOR)
Best Overall response (BOR) is defined as the best response recorded from the start of study treatment until disease progression or recurrence according to Prostate Cancer Working Group 3-modified Response Evaluation Criteria in Solid Tumors, version 1.1, as assessed by the investigator.
Measured: From randomization until disease progression or death from any cause, whichever occurred first, assessed up to approximately 79 months
Phase II (Group A): Duration of Response (DOR)
Duration of response (DOR) is defined, for participants with a confirmed complete or partial response, as the time from the first documented response until the first documented disease progression according to Prostate Cancer Working Group 3-modified Response Evaluation Criteria in Solid Tumors, version 1.1, as assessed by the investigator, or death from any cause.
Measured: From the first documented complete or partial response until disease progression or death from any cause, whichever occurred first, assessed up to approximately 79 months
Phase II (Group A): Prostate-Specific Antigen 50 (PSA50) response rate
Prostate-Specific Antigen 50 (PSA50) response is defined as a reduction of at least 50% from baseline in prostate-specific antigen at any post-baseline time point, confirmed by a second prostate-specific antigen assessment performed at least 3 weeks later.
Measured: From randomization until the last prostate-specific antigen assessment, assessed up to approximately 79 months
Phase II (Group A): Prostate-Specific Antigen (PSA) Response below 0.1 ng/mL
Prostate-Specific Antigen (PSA) Response below 0.1 ng/mL is defined as achievement of a prostate-specific antigen level below 0.1 ng/mL at any post-baseline time point.
Measured: From randomization until the last prostate-specific antigen assessment, assessed up to approximately 79 months
Phase II (Group A): Time to castration-resistant prostate cancer (CRPC)
Time to castration-resistant prostate cancer was defined as the time from randomization to the first occurrence of prostate-specific antigen progression, radiographic progression based on bone lesions, or radiographic progression based on soft-tissue or visceral lesions.
Measured: From randomization until prostate-specific antigen progression, radiographic progression in bone, or radiographic progression in soft-tissue or visceral lesions, whichever occurred first, assessed up to approximately 79 months
Phase II (Group A): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.The incidence, type, frequency, seriousness, and severity of adverse events and serious adverse events will be summarized by treatment arm. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
Measured: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase II (Group A): Number of Participants with dose adjustments
The number of participants with dose reductions, dose interruptions, or permanent discontinuations, including the reasons for the dose adjustments, will be summarized by treatment arm.
Measured: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase II (Group A): Dose Intensity
Dose intensity, calculated as the actual cumulative dose received divided by the actual duration of exposure, and relative dose intensity, calculated as dose intensity divided by planned dose intensity, will be summarized using descriptive statistics for each study drug and treatment arm.
Measured: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase II (Group A): Duration of exposure to each study drug
The duration of exposure, in months, to each study drug will be summarized using descriptive statistics by treatment arm.
Measured: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase II (Group A): Plasma concentrations of tulmimetostat and darolutamide in participants included in intensive pharmacokinetic sampling
Plasma concentrations of tulmimetostat and darolutamide will be evaluated in selected participants receiving tulmimetostat in combination with darolutamide.
Measured: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days
Phase II (Group A): Plasma concentrations of Tulmimetostat
Plasma concentrations of tulmimetostat will be evaluated using pharmacokinetic samples collected from participants receiving tulmimetostat across the evaluated Phase II dose levels.
Measured: Cycles 1 and 2, Day 1: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days
Phase II (Group A): Time to first symptomatic skeletal event (TTSSE)
Time to first symptomatic skeletal event (TTSSE) is defined as the time from the first dose of study treatment to the first occurrence of a new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgery, radiation therapy to relieve bone pain, or death from any cause, whichever occurred first, as assessed by the investigator.
Measured: From the first dose of study treatment until the first symptomatic skeletal event, assessed up to approximately 79 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start13 Jan 2026
- Primary completion2 Aug 2032 (estimated)
- Study completion2 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I is an open-label, parallel dose-escalation study comprising two treatment groups: Group A (tulmimetostat + darolutamide) and Group B (tulmimetostat + abiraterone). Phase II is a randomized, open-label, multicenter dose-expansion study evaluating one or two dose levels of tulmimetostat in combination with darolutamide versus darolutamide alone.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 181 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190300
- Sponsor's protocol ID
- CDZR123C12101
- Other IDs
- 2025-521873-15-00, 2025
- Acronym
- TulmiSTAR-02
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT07190300
- Acronym / sponsor ID
- TulmiSTAR-02 / CDZR123C12101
- Keywords
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), Enhancer of Zeste Homolog 2 (EZH2), Androgen Receptor (AR), Androgen Receptor Pathway Inhibitors (ARPIs), Prostate-Specific Antigen (PSA), PSA Response Rate, TulmiSTAR-02, Tulmimetostat (DZR123)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 181 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 2 Aug 2032 (estimated)
- Study completion
- 2 Aug 2032 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Group A (Part 1): tulmimetostat in combination with darolutamide.
- 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:
- A 30-day safety follow-up visit after permanent discontinuation of study treatment.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Phase I is an open-label, parallel dose-escalation study comprising two treatment groups: Group A (tulmimetostat + darolutamide) and Group B (tulmimetostat + abiraterone). Phase II is a randomized, open-label, multicenter dose-expansion study evaluating one or two dose levels of tulmimetostat in combination with darolutamide versus darolutamide alone.
| Arm | Type | Receives |
|---|---|---|
| Phase I: Group A (part 1) | Experimental | Drug: Tulmimetostat, Drug: Darolutamide, Drug: Androgen Deprivation Therapy (ADT)Tulmimetostat administered orally once daily (QD) at escalating dose levels in combination with darolutamide 600 mg orally twice daily (BID). Participants will continue androgen deprivation therapy (ADT) throughout the study. |
| Phase I: Group B (part 2) | Experimental | Drug: Tulmimetostat, Drug: Abiraterone, Drug: Prednisone/Prednisolone, Drug: Androgen Deprivation Therapy (ADT)Tulmimetostat administered orally once daily (QD) at escalating dose levels in combination with abiraterone 1000 mg orally once daily (QD). Participants will continue androgen deprivation therapy (ADT). Abiraterone will be administered with prednisone/prednisolone according to local prescribing information. |
| Phase II: Arm 1 | Experimental | Drug: Tulmimetostat, Drug: Darolutamide, Drug: Androgen Deprivation Therapy (ADT)Tulmimetostat Dose 1 orally once daily (QD) in combination with darolutamide 600 mg orally twice daily (BID). Participants will continue androgen deprivation therapy (ADT). |
| Phase II: Arm 2 (Optional) | Experimental | Drug: Tulmimetostat, Drug: Darolutamide, Drug: Androgen Deprivation Therapy (ADT)Tulmimetostat Dose 2 orally once daily (QD) in combination with darolutamide 600 mg orally twice daily (BID). Participants will continue androgen deprivation therapy (ADT). This arm will be included if two recommended dose(s) for expansion are selected from Phase I. |
| Phase II: Arm 3 (Control) | Active comparator | Drug: Darolutamide, Drug: Androgen Deprivation Therapy (ADT)Darolutamide 600 mg orally twice daily (BID). Participants will continue androgen deprivation therapy (ADT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adult men ≥ 18 years old with de novo or recurrent mHSPC (without neuroendocrine or small cell features). The tumor lesion(s) may be located in the bone, soft tissue/visceral region, or both.
- Participants must have castrate levels of testosterone, i.e., ≤ 50 ng/dL (≤ 1.7 nM).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate bone marrow and organ function
- Prior ADT: Participants must have started ADT at least 1 month (at least 28 days) but no more than 12 months before study entry and be willing to continue ADT during treatment
Key exclusion criteria (14 listed)
- Participants with evidence of mCRPC or biochemical recurrence / PSA only disease or asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy and with normal PSA for ≥ 1 year prior to the start of study treatment.
- Participants who have not received ARPI treatment for mHSPC and present with PSA levels of ≤0.5 ng/mL or those with prior/ongoing ARPI treatment presenting with PSA levels of ≤ 0.2 ng/mL prior to treatment assignment/randomization.
- Participants with CNS metastases are excluded unless:
- Concurrent use of first-generation anti-androgens (like bicalutamide). Prior use of a first-generation anti-androgen drug in the context of ADT initiation with a GNRH analog is allowed, provided it was administered for ≤14 days and the last dose was administered ≥7 days from the study entry.
- Systemic ketoconazole is used as antineoplastic treatment for prostate cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TulmimetostatAlso: DZR123Tulmimetostat is an oral dual EZH1/EZH2 inhibitor administered once daily. In Phase I, escalating dose levels will be evaluated in combination with darolutamide or abiraterone. In Phase II, one or two dose levels selected from Phase I will be evaluated in combination with darolutamide. | Drug | Phase I: Group A (part 1), Phase I: Group B (part 2), Phase II: Arm 1, Phase II: Arm 2 (Optional) |
| DarolutamideDarolutamide 600 mg administered orally twice daily (BID). | Drug | Phase I: Group A (part 1), Phase II: Arm 1, Phase II: Arm 2 (Optional), Phase II: Arm 3 (Control) |
| AbirateroneAbiraterone 1000 mg administered orally once daily (QD) in combination with prednisone/prednisolone according to local prescribing information. | Drug | Phase I: Group B (part 2) |
| Prednisone/PrednisoloneOral corticosteroid administered with abiraterone in Phase I Group B according to local prescribing information. | Drug | Phase I: Group B (part 2) |
| Androgen Deprivation Therapy (ADT)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]). All participants will continue ADT throughout study participation. | Drug | Phase I: Group A (part 1), Phase I: Group B (part 2), Phase II: Arm 1, Phase II: Arm 2 (Optional), Phase II: Arm 3 (Control) |
Primary outcome
Phase I (Group A and Group B): Dose-limiting toxicities (DLTs)
Time frame: From the first dose of study treatment through the end of Cycle 1, up to 28 days
A dose-limiting toxicity was defined as an adverse event or abnormal laboratory value that was not clearly attributable to the underlying disease or an extraneous cause, occurred during the first 28 days of treatment with tulmimetostat, and met the protocol-defined dose-limiting toxicity criteria. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Dose-limiting toxicities were included in the Bayesian Logistic Regression Model used to support dose-escalation decisions.
Phase I (Group A and Group B): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
The incidence, type, frequency, seriousness, and severity of adverse events and serious adverse events will be summarized. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
Phase I (Group A and Group B): Number of Participants with dose adjustments
Time frame: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
The number of participants with dose reductions, dose interruptions, or permanent discontinuations, including the reasons for the dose adjustments, will be summarized by treatment group and dose cohort.
Phase I (Group A and Group B): Dose Intensity
Time frame: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Dose intensity, calculated as the actual cumulative dose received divided by the actual duration of exposure, and relative dose intensity, calculated as the dose intensity divided by the planned dose intensity, will be summarized using descriptive statistics for each study drug.
Phase I (Group A and Group B): Duration of exposure to each study drug
Time frame: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
The duration of exposure, in months, to each study drug will be summarized using descriptive statistics by treatment group and dose cohort.
Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL at Month 6
Time frame: At Month 6, with confirmation by a second prostate-specific antigen assessment performed at least 3 weeks later
Prostate-Specific Antigen (PSA) response rate is defined as the proportion of participants who achieved a prostate-specific antigen level below 0.2 ng/mL at Month 6, confirmed by a second prostate-specific antigen assessment performed at least 3 weeks later.
21 secondary outcomes
Phase I (Group A): Plasma concentrations of Tulmimetostat and Darolutamide
Time frame: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days
Phase I (Group A): AUC of Tulmimetostat and Darolutamide
Time frame: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days
Phase I (Group A): Maximum Observed Plasma Concentration (Cmax) of Tulmimetostat and Darolutamide
Time frame: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days
Phase I (Group B): Plasma concentrations of Tulmimetostat and Abiraterone
Time frame: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Day 2: 0 and 24 hours post-dose; Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days.
Phase I (Group B): AUC of Tulmimetostat and Abiraterone
Time frame: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Day 2: 0 and 24 hours post-dose; Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days.
Phase I (Group B): Maximum Observed Plasma Concentration (Cmax) of Tulmimetostat and Abiraterone
Time frame: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Day 2: 0 and 24 hours post-dose; Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days.
Phase II (Group A): Radiographic progression free survival (rPFS)
Time frame: From randomization until the first documented radiographic disease progression or death from any cause, whichever occurs first, assessed up to approximately 79 months
Phase II (Group A):Overall survival (OS)
Time frame: From randomization until death from any cause, assessed up to approximately 79 months
Phase II (Group A): Objective Response Rate (ORR)
Time frame: From randomization until disease progression, death, or the last adequate tumor assessment, assessed up to approximately 79 months
Phase II (Group A): Best Overall Response (BOR)
Time frame: From randomization until disease progression or death from any cause, whichever occurred first, assessed up to approximately 79 months
Phase II (Group A): Duration of Response (DOR)
Time frame: From the first documented complete or partial response until disease progression or death from any cause, whichever occurred first, assessed up to approximately 79 months
Phase II (Group A): Prostate-Specific Antigen 50 (PSA50) response rate
Time frame: From randomization until the last prostate-specific antigen assessment, assessed up to approximately 79 months
Phase II (Group A): Prostate-Specific Antigen (PSA) Response below 0.1 ng/mL
Time frame: From randomization until the last prostate-specific antigen assessment, assessed up to approximately 79 months
Phase II (Group A): Time to castration-resistant prostate cancer (CRPC)
Time frame: From randomization until prostate-specific antigen progression, radiographic progression in bone, or radiographic progression in soft-tissue or visceral lesions, whichever occurred first, assessed up to approximately 79 months
Phase II (Group A): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase II (Group A): Number of Participants with dose adjustments
Time frame: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase II (Group A): Dose Intensity
Time frame: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase II (Group A): Duration of exposure to each study drug
Time frame: From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months
Phase II (Group A): Plasma concentrations of tulmimetostat and darolutamide in participants included in intensive pharmacokinetic sampling
Time frame: Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days
Phase II (Group A): Plasma concentrations of Tulmimetostat
Time frame: Cycles 1 and 2, Day 1: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days
Phase II (Group A): Time to first symptomatic skeletal event (TTSSE)
Time frame: From the first dose of study treatment until the first symptomatic skeletal event, assessed up to approximately 79 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
31 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tulmimetostat, Darolutamide and Abiraterone in people with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by Novartis Pharmaceuticals at 31 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, France, Hungary, Spain, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I (Group A and Group B): Dose-limiting toxicities (DLTs) (time frame: From the first dose of study treatment through the end of Cycle 1, up to 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.