RecruitingNCT07190300TulmiSTAR-02Updated Sep 29, 2026

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 interventional study of Tulmimetostat and Darolutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), sponsored by Novartis Pharmaceuticals. Recruiting at 31 sites in 14 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Novartis Pharmaceuticals · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 181
Allocation: Randomized
Ages: 18 Years and older
Sex: Male

Study 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). 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.

Conditions studied

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Browse trials for

Bulbo-Spinal Atrophy, X-Linked 33

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

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

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:
- 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.

Key Exclusion Criteria:

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.
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

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 181 participants (estimated)

Study arms

Experimental
Phase I: Group A (part 1)
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.
Drug: Tulmimetostat · Drug: Darolutamide · Drug: Androgen Deprivation Therapy (ADT)
Experimental
Phase I: Group B (part 2)
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.
Drug: Tulmimetostat · Drug: Abiraterone · Drug: Prednisone/Prednisolone · Drug: Androgen Deprivation Therapy (ADT)
Experimental
Phase II: Arm 1
Tulmimetostat Dose 1 orally once daily (QD) in combination with darolutamide 600 mg orally twice daily (BID). Participants will continue androgen deprivation therapy (ADT).
Drug: Tulmimetostat · Drug: Darolutamide · Drug: Androgen Deprivation Therapy (ADT)
Experimental
Phase II: Arm 2 (Optional)
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.
Drug: Tulmimetostat · Drug: Darolutamide · Drug: Androgen Deprivation Therapy (ADT)
Active comparator
Phase II: Arm 3 (Control)
Darolutamide 600 mg orally twice daily (BID). Participants will continue androgen deprivation therapy (ADT).
Drug: Darolutamide · Drug: Androgen Deprivation Therapy (ADT)

Interventions

DrugTulmimetostat
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.
Also known as: DZR123
DrugDarolutamide
Darolutamide 600 mg administered orally twice daily (BID).
DrugAbiraterone
Abiraterone 1000 mg administered orally once daily (QD) in combination with prednisone/prednisolone according to local prescribing information.
DrugPrednisone/Prednisolone
Oral corticosteroid administered with abiraterone in Phase I Group B according to local prescribing information.
DrugAndrogen 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.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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): 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.
Time frame: At Month 6, with confirmation by a second prostate-specific antigen assessment performed at least 3 weeks later

Secondary outcomes

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.
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
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.
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
The maximum observed plasma concentration of tulmimetostat and darolutamide will be derived, as applicable, and summarized using descriptive statistics.
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
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.
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
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.
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
The maximum observed plasma concentration of tulmimetostat and abiraterone will be derived, as applicable, and summarized using descriptive statistics.
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)
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.
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)
Overall survival (OS) is defined as the time from randomization to death from any cause.
Time frame: 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.
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)
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.
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)
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.
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
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.
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
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.
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 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.
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)
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.
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
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.
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
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.
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
The duration of exposure, in months, to each study drug will be summarized using descriptive statistics by treatment arm.
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
Plasma concentrations of tulmimetostat and darolutamide will be evaluated in selected participants receiving tulmimetostat in combination with 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 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.
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 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.
Time frame: From the first dose of study treatment until the first symptomatic skeletal event, assessed up to approximately 79 months

Study locations

30 of 31 sites recruiting

Univ of Alabama at Birmingham
Birmingham, Alabama 35294-3300, United States
- Luke Hanna · Contact · lukehanna@uabmc.edu
- Joelle Hamilton · Principal investigator
Recruiting
Uni Of Iowa Hospitals And Clinics
Iowa City, Iowa 52242, United States
- Kerri Fitch · Contact · kerri-fitch@uiowa.edu
- Fernando Maciel Barbosa · Principal investigator
Recruiting
University of Kansas Cancer Center
Westwood, Kansas 66205, United States
- Katie Looney · Contact · klooney2@kumc.edu
- Haoran Li · Principal investigator
Recruiting
Wichita Urology Group PA
Wichita, Kansas 67226, United States
- Tyler Gentry · Contact · tgentry@wichitaurology.com
- Timothy Richardson · Principal investigator
Recruiting
Duke University Medical Center
Durham, North Carolina 27710, United States
- Tykeytra Dale · Contact · tykeytra.dale@duke.edu
- Jeffrey Shevach · Principal investigator
Recruiting
Medical University of South Carolina MUSC
Charleston, South Carolina 29425, United States
- Renee Tucker · Contact · tuckerr@musc.edu · 843-792-7560
- Kevin Becker · Principal investigator
Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572, United States
- Lindsey Rabon · Contact · lindsey.rabon@startresearch.com · 843-839-1679
- Neal Shore · Principal investigator
Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah 84112, United States
- Alena Turner · Contact · alena.turner@hci.utah.edu
- Neeraj Agarwal · Principal investigator
Recruiting
Novartis Investigative Site
Camperdown, New South Wales 2050, Australia
Withdrawn
Novartis Investigative Site
Wollongong, New South Wales 2500, Australia
Recruiting
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul 90610-001, Brazil
Recruiting
Novartis Investigative Site
Montreal, Quebec H2X 1R9, Canada
Recruiting
Novartis Investigative Site
Guangzhou, 510060, China
Recruiting
Novartis Investigative Site
Créteil, 94010, France
Recruiting
Novartis Investigative Site
Lille, 59020, France
Recruiting
Novartis Investigative Site
Nantes, 44093, France
Recruiting
Novartis Investigative Site
Jena, Thuringia 07740, Germany
Recruiting
Novartis Investigative Site
Essen, 45147, Germany
Recruiting
Novartis Investigative Site
Hong Kong, 999077, Hong Kong
Recruiting
Novartis Investigative Site
Budapest, 1083, Hungary
Recruiting
Novartis Investigative Site
Budapest, 1122, Hungary
Recruiting
Novartis Investigative Site
Szeged, 6725, Hungary
Recruiting
Novartis Investigative Site
Rozzano, MI 20089, Italy
Recruiting
Novartis Investigative Site
Verona, VR 37134, Italy
Recruiting
Novartis Investigative Site
Seoul, 05505, South Korea
Recruiting
Novartis Investigative Site
Seoul, 06591, South Korea
Recruiting
Novartis Investigative Site
Madrid, 28034, Spain
Recruiting
Novartis Investigative Site
Madrid, 28040, Spain
Recruiting
Novartis Investigative Site
Madrid, 28222, Spain
Recruiting
Novartis Investigative Site
Ankara, Sihhiye Altindag 06230, Turkey (Türkiye)
Recruiting
Novartis Investigative Site
London, W1G 6AD, United Kingdom
Recruiting

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07190300
Lead sponsor: Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Sep 24, 2025
Start date: Jan 13, 2026
Primary completion: Aug 2, 2032 (estimated)
Completion: Aug 2, 2032 (estimated)
Last update: Sep 29, 2026

Study contacts

Novartis Pharmaceuticals

Contact

novartis.email@novartis.com

1-888-669-6682

Novartis Pharmaceuticals

Contact

novartis.email@novartis.com

+41613241111

Novartis Pharmaceuticals

study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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