NCT07190300ClinicalTrials.gov

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)

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

RecruitingTaking participants now, according to the registry record.

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In brief

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

Phase 1 / Phase 2181 participants sought31 sites14 countries

Registered in 1 registry

ClinicalTrials.govNCT07190300Open this record at ClinicalTrials.govSynced 2 months ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-09-24; recorded start 2026-01-13
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1128 other studies in this databaseCounted from the lead sponsor named in the record (Novartis Pharmaceuticals)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 31 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 181 participants (target), run at 31 sites, across 14 countries.

How this score is built

Enrolment21/40
181 participants (target)
Site count18/25
31 sites
Country count12/15
14 countries
Planned duration10/10
Planned over about 80 months
Sponsor scale10/10
Novartis Pharmaceuticals has led 1,104 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

The study consists of two phases: 1. Phase I: The Phase I part includes two groups: Part 1 will assess the combination of tulmimetostat with darolutamide (Group A), and Part 2 will assess tulmimetostat with abiraterone (Group B). The primary objective of Phase I is to determine the recommended dose escalations (RDEs) for each combination, with enrollment using a staggered approach between groups. Participants in both groups will continue androgen deprivation therapy (ADT) to maintain castrate testosterone levels (\<50 ng/dL or \<1.7 nmol/L), as determined by the investigator based on local guidelines. In Group B, abiraterone will be administered with an oral corticosteroid (prednisone or prednisolone) per local prescribing information. 2. Phase II: Phase II is a randomized, open-label, multicenter dose-expansion study to further evaluate the recommended dose(s) of tulmimetostat in combination with darolutamide and provide proof-of-concept for efficacy and safety. Participants will be randomized to receive tulmimetostat plus darolutamide or darolutamide alone. Eligible participants include those with metastatic hormone-sensitive prostate cancer (mHSPC) who are either de novo or recurrent, without prior radioligand therapy, but who may have received prior taxane-based chemotherapy and/or androgen receptor pathway inhibitors (ARPIs), excluding darolutamide. The study evaluates tulmimetostat-based combinations as potential treatment options for men with mHSPC. The study for each participant consists of a screening period, a study treatment period followed by a post treatment long-term follow-up.

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Eligibility

Eligibility
Sex	Male
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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: 1. 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 2. 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. * Phase II: 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. * 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. Other inclusion/exclusion criteria may apply

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 1 / Phase 2
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	QUADRUPLE (4)
Enrolment	181 participants sought

Sponsor and collaborators

Novartis Pharmaceuticals Sponsor

Arms and interventions

Phase II: Arm 2EXPERIMENTAL
Tulmimetostat dose 2 PO + Darolutamide 600 mg PO BID
Phase II: Arm 3ACTIVE_COMPARATOR
Darolutamide 600 mg PO BID
Phase I: Group A (part 1)EXPERIMENTAL
Tulmimetostat oral (PO) once a day (QD) escalating doses + Darolutamide 600 mg twice a day (BID)
Phase I: Group B (part 2)EXPERIMENTAL
Tulmimetostat PO QD escalating doses + Abiraterone 1000 mg PO QD
Phase II: Arm 1EXPERIMENTAL
Tulmimetostat dose 1 PO + Darolutamide 600 mg PO BID

Interventions

Drug Abiraterone
1000 mg is administered orally QD
Drug Darolutamide
600 mg is administered orally BID
Drug Tulmimetostat
Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

Outcome measures

Primary outcome
Phase I (Group A and Group B): Dose-limiting toxicities (DLTs)
A dose-limiting toxicity is defined as an adverse event or abnormal laboratory value, not clearly due to underlying disease or extraneous causes, that occurs within the first 28 days of treatment with tulmimetostat and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. For the purpose of dose-escalation decisions, DLTs will be considered and included in the Bayesian Logistic Regression Model (BLRM).
Time frame Up to 28 days
Primary outcome
Phase I (Group A and Group B): 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.
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 79 months
Primary outcome
Phase I (Group A and Group B): Number of Participants with dose adjustments
The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 79 months
Primary outcome
Phase I (Group A and Group B): Dose Intensity
Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity) will be summarized by means of descriptive statistics
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 79 months
Primary outcome
Phase I (Group A and Group B): Duration of exposure to each study drug
Duration of exposure (in months) to each study drug will be summarized by means of descriptive statistics
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 79 months
Primary outcome
Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL
Prostate-Specific Antigen (PSA) response rate is defined as proportion of participants who achieved a decline in PSA to \< 0.2 ng/mL at month 6 months, confirmed by a second PSA measurement ≥ 3 weeks later.
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 79 months
Secondary outcome
Phase I (Group A): Plasma concentrations of Tulmimetostat and Darolutamide
Tulmimetostat and Darolutamide pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms
Time frame Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase I (Group A): AUC of Tulmimetostat and Darolutamide
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics.
Time frame Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase I (Group A): Cmax of Tulmimetostat and Darolutamide
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Time frame Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase I (Group B): Plasma concentrations of Tulmimetostat and Abiraterone
Tulmimetostat and Abiraterone pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms
Time frame Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Day 2 (0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase I (Group B): AUC of Tulmimetostat and Abiraterone
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics.
Time frame Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Day 2 (0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase I (Group B): Cmax of Tulmimetostat and Abiraterone
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Time frame Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Day 2 (0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase II (Group A): Radiographic progression free survival (rPFS)
Radiographic progression free survival (rPFS) is defined as the time between randomization and the first occurrence of disease progression as per PCWG3-modified RECIST v1.1 or death due to any cause
Time frame From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 79 months
Secondary outcome
Phase II (Group A):Overall survival (OS)
Overall survival (OS) is defined as the time between randomization to date of death due to any cause
Time frame From date of randomization until date of death from any cause, assessed up to approximately 79 months
Secondary outcome
Phase II (Group A): Objective response (OR)
Objective response (OR) is defined as a confirmed Complete Response (CR) or Partial Response (PR) per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1 as assessed by the Investigator
Time frame From date of randomization until date of confirmed Complete Response (CR) or Partial Response (PR), assessed up to approximately 79 months
Secondary outcome
Phase II (Group A): Best Overall response (BOR)
Best Overall response (BOR) is defined as the best response per PCWG3-modified RECIST 1.1 as assessed by the Investigator from the start of the treatment until disease progression/recurrence
Time frame From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 79 months
Secondary outcome
Phase II (Group A): Duration of response (DOR)
Duration of response (DOR) defined as time between first documented CR/PR and disease progression per PCWG3-modified RECIST 1.1 as assessed by the Investigator or death due to any cause
Time frame From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 79 months
Secondary outcome
Phase II (Group A): Prostate-Specific Antigen 50 (PSA50)
Prostate-Specific Antigen 50 (PSA50) is defined as a ≥ 50% decrease in PSA levels from baseline at any timepoint, confirmed by a second PSA measurement ≥ 3 weeks without any PSA progression in between
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 79 months
Secondary outcome
Phase II (Group A): Prostate-Specific Antigen (PSA) Response of <0.1 ng/mL
Prostate-Specific Antigen (PSA) Response of \<0.1 ng/mL is defined as PSA level \< 0.1 ng/mL at any timepoint during the trial from randomization
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 79 months
Secondary outcome
Phase II (Group A): Time to castration-resistant prostate cancer (CRPC)
Time to castration-resistant prostate cancer (CRPC) is defined as the time from randomization to the first occurrence of one of the following events: PSA progression, radiological progression by bone lesions, or radiological progression by soft tissue and visceral lesions
Time frame From date of randomization until date of PSA progression, radiological progression by bone lesions, or radiological progression by soft tissue and visceral lesions, whichever comes first, assessed up to approximately 79 months
Secondary outcome
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.
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 79 months
Secondary outcome
Phase II (Group A): Number of Participants with dose adjustments
The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 79 months
Secondary outcome
Phase II (Group A): Dose Intensity
Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity) will be summarized by means of descriptive statistics
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 79 months
Secondary outcome
Phase II (Group A): Duration of exposure to each study drug
Duration of exposure to each study drug will be summarized by means of descriptive statistics
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 79 months
Secondary outcome
Phase II (Group A): Plasma concentrations of Tulmimetostat and Darolutamide
In selected number of participants receiving Tulmimetostat and Darolutamide combination therapy in Phase II, or in selected number of participants if only one dose level of Tulmimetostat is evaluated in combination with Darolutamide in Phase II, Tulmimetostat and Darolutamide pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms
Time frame Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase II (Group A): AUC of Tulmimetostat and Darolutamide
In selected number of participants receiving tulmimetostat and darolutamide combination therapy in Phase II, or in selected number of participants if only one dose level of tulmimetostat is evaluated in combination with darolutamide in Phase II, venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics.
Time frame Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase II (Group A): Cmax of Tulmimetostat and Darolutamide
In selected number of participants receiving tulmimetostat and darolutamide combination therapy in Phase II, or in selected number of participants if only one dose level of tulmimetostat is evaluated in combination with darolutamide in Phase II, venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Time frame Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase II (Group A): Plasma concentrations of Tulmimetostat
Tulmimetostat pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms
Time frame Cycle 1-2: Day 1 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase II (Group A): AUC of Tulmimetostat
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics.
Time frame Cycle 1-2: Day 1 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase II (Group A): Cmax of Tulmimetostat
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Time frame Cycle 1-2: Day 1 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.
Secondary outcome
Phase II (Group A): Time to first symptomatic skeletal event (TTSSE)
Time to first symptomatic skeletal event (TTSSE) is defined as the time from randomization to the first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first
Time frame From randomization until the first occurrence of a new symptomatic bone fracture, spinal cord compression, tumor-related orthopedic surgery, radiation therapy for bone pain, or death, assessed up to 79 months.

Dates

Dates
Start date	January 13, 2026 (actual)
Primary completion	August 2, 2032 (estimated)
Completion	August 2, 2032 (estimated)
First posted	September 24, 2025 (actual)
Last updated	June 23, 2026
Results posted	Not stated in the registry record
Status last verified	June 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

30 sites are recruiting

Australia

Australia
Facility	City	State or region	Status
Novartis Investigative Site	Camperdown	New South Wales	Withdrawn
Novartis Investigative Site	Wollongong	New South Wales	Recruiting

Brazil

Brazil
Facility	City	State or region	Status
Novartis Investigative Site	Porto Alegre	Rio Grande do Sul	Recruiting

Canada

Canada
Facility	City	State or region	Status
Novartis Investigative Site	Montreal	Quebec	Recruiting

China

China
Facility	City	State or region	Status
Novartis Investigative Site	Guangzhou		Recruiting

France

France
Facility	City	Status
Novartis Investigative Site	Créteil	Recruiting
Novartis Investigative Site	Lille	Recruiting
Novartis Investigative Site	Nantes	Recruiting

Germany

Germany
Facility	City	State or region	Status
Novartis Investigative Site	Essen		Recruiting
Novartis Investigative Site	Jena	Thuringia	Recruiting

Hong Kong

Hong Kong
Facility	City	State or region	Status
Novartis Investigative Site	Hong Kong		Recruiting

Hungary

Hungary
Facility	City	Status
Novartis Investigative Site	Budapest	Recruiting
Novartis Investigative Site	Budapest	Recruiting
Novartis Investigative Site	Szeged	Recruiting

Italy

Italy
Facility	City	State or region	Status
Novartis Investigative Site	Rozzano	MI	Recruiting
Novartis Investigative Site	Verona	VR	Recruiting

South Korea

South Korea
Facility	City	State or region	Status
Novartis Investigative Site	Seoul		Recruiting
Novartis Investigative Site	Seoul		Recruiting

Spain

Spain
Facility	City	Status
Novartis Investigative Site	Madrid	Recruiting
Novartis Investigative Site	Madrid	Recruiting
Novartis Investigative Site	Madrid	Recruiting

Turkey (Türkiye)

Turkey (Türkiye)
Facility	City	State or region	Status
Novartis Investigative Site	Ankara	Sihhiye-Altindag	Recruiting

United Kingdom

United Kingdom
Facility	City	State or region	Status
Novartis Investigative Site	London		Recruiting

United States

United States
Facility	City	State or region	Status
Univ of Alabama at Birmingham	Birmingham	Alabama	Recruiting
Medical University of South Carolina MUSC	Charleston	South Carolina	Recruiting
Duke University Medical Center	Durham	North Carolina	Recruiting
Uni Of Iowa Hospitals And Clinics	Iowa City	Iowa	Recruiting
Carolina Urologic Research Center	Myrtle Beach	South Carolina	Recruiting
Huntsman Cancer Institute	Salt Lake City	Utah	Recruiting
University of Kansas Cancer Center	Westwood	Kansas	Recruiting
Wichita Urology Group PA	Wichita	Kansas	Recruiting

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07190300

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Australia

Brazil

Canada

China

France

Germany

Hong Kong

Hungary

Italy

South Korea

Spain

Turkey (Türkiye)

United Kingdom

United States

Study documents

Changes over time