NCT07206056ClinicalTrials.gov

An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)

TulmiSTAR-01: A Two-part, Phase I Dose Escalation and Expansion Followed by a Randomized, Open-label Multicenter, Phase II Study to Assess the Safety and Efficacy of the Combination of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) vs Standard of Care in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer

RecruitingTaking participants now, according to the registry record.

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In brief

This is a two-part, Phase I/II, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with progressive metastatic castrate resistant prostate cancer (mCRPC).

Phase 1 / Phase 2188 participants sought35 sites14 countries

Registered in 1 registry

ClinicalTrials.govNCT07206056Open this record at ClinicalTrials.govSynced 2 days 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 2025-10-03; recorded start 2025-10-15
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
Not stated: Open label (no blinding)Masking is recorded as none (open label)
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 rigourSTRONG

A strong methodological 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
Blinding0/20
Open-label
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: 33 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: 188 participants (target), run at 35 sites, across 14 countries.

How this score is built

Enrolment22/40
188 participants (target)
Site count18/25
33 sites
Country count12/15
14 countries
Planned duration10/10
Planned over about 62 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 Phase 1 study, comprised of Parts 1a and 1b, aims to assess the safety and tolerability of the combination of tulmimetostat and JSB462: 1. Part 1a is the parallel dose escalation that aims to determine the recommended dose(s) of tulmimetostat and JSB462, in combination, for further exploration. 2. Part 1b is the dose expansion/optimization that aims to determine the recommended dose of the combination for Phase II. The purpose of the Phase II study (Part 2) is to compare the combination of tulmimetostat with JSB462 in terms of the biochemical response as assessed by PSA50 compared to the standard of care (SoC) in adult men with progressive, taxane-naive mCRPC.

Conditions

Progressive Metastatic Castrate Resistant Prostate Cancer

Eligibility

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

Eligibility as written in the registry

Key Inclusion Criteria: * Participant is an adult man ≥ 18 years of age. * Participant must have histologically and/or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell features (current or prior biopsy of the prostate and/or metastatic site). * Participant must have ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to start of treatment (Part 1a dose escalation) or randomization (Part 1b dose expansion and Part 2). * Participant must have progressive mCRPC. * Participant must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Prior ARPI therapy: * Part 1a and 1b only: must have progressed on at least one prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide). * Part 2 only: must have progressed on one prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide). * Prior chemotherapy: * Part 1a dose escalation only: may have received ≤ 2 prior lines of chemotherapy in CRPC setting. Note: Prior chemotherapy is permitted in the HSPC setting. * Part 1b dose expansion/optimization only: may have received up to one prior line of chemotherapy in CRPC setting. Note: Prior chemotherapy is permitted in the HSPC setting. * Part 2 only: Participants must be taxane-naïve in mCRPC setting; prior chemotherapy permitted in HSPC setting only Key Exclusion Criteria: * Previous treatment with any PRC2 inhibitor, including but not limited to EZH2 inhibitors, EZH2/1 inhibitors, or embryonic ectoderm development (EED) inhibitors. * Previous treatment with a protein degrader compound that targets the AR. * Known hypersensitivity or contraindication to any of the study treatment components or its excipients or to drugs of similar chemical classes. * Treatment with any investigational agent within 28 days (or 5 half-lives, whichever is longer) prior to study entry. * Previous treatment with radioligand therapy in the mCRPC setting, except in Part 1a where participants may have received RLT in mCRPC setting. * 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 study entry. * Participants with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purpose of maintaining neurologic integrity. Those with leptomeningeal disease are eligible if those areas have been treated, are stable, and no neurological impairment is present. For those with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain with MRI (preferred) or CT with contrast. Other protocol-defined 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	NONE (0)
Enrolment	188 participants sought

Sponsor and collaborators

Novartis Pharmaceuticals Sponsor

Arms and interventions

Part 2: Arm 2ACTIVE_COMPARATOR
Standard of Care at the discretion of the investigator
Part 1b : Arm AEXPERIMENTAL
Tulmimetostat Dose 1 QD + JSB462 QD
Part 1b: Arm BEXPERIMENTAL
Tulmimetostat Dose 2 QD + JSB462 QD
Part 1a: Cohort DL1AEXPERIMENTAL
Tulmimetostat DL1 QD + JSB462 Dose 1 QD
Part 1a: Cohort DL1BEXPERIMENTAL
Tulmimetostat DL1 QD + JSB462 Dose 2 QD
Part 1a: Cohort DL2AEXPERIMENTAL
Tulmimetostat DL2 QD + JSB462 Dose 1 QD
Part 1a: Cohort DL2BEXPERIMENTAL
Tulmimetostat DL2 QD + JSB462 Dose 2 QD
Part 1a: Cohort DL3AEXPERIMENTAL
Tulmimetostat DL3 QD + JSB462 Dose 1 QD
Part 1a: Cohort DL3BEXPERIMENTAL
Tulmimetostat DL3 QD + JSB462 Dose 2 QD
Part 2: Arm 1EXPERIMENTAL
Tulmimetostat RP2D QD + JSB462 QD

Interventions

Drug JSB462 Dose 1 QD
JSB462 Dose 1 QD
Drug JSB462 Dose 2 QD
JSB462 Dose 2 QD
Drug JSB462 QD
The dose of JSB462 QD will be determined based on the totality of data from Part 1a
Drug Standard of Care (SoC)
Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator
Drug Tulmimetostat DL1 QD
Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))
Drug Tulmimetostat DL2 QD
Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))
Drug Tulmimetostat DL3 QD
Part 1a (dose escalation): Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))
Drug Tulmimetostat Doses 1 or 2 QD
Part 1b (dose expansion and optimization): tulmimetostat doses 1 or 2 QD
Drug Tulmimetostat RP2D QD
Part 2: tulmimetostat Recommended Phase 2 Dose (RP2D) QD

Outcome measures

Primary outcome
Part 1a: Dose-limiting toxicities (DLTs)
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the first 28 days of treatment with tulmimetostat and JSB462 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
Part 1a and Part 1b: 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 14 months
Primary outcome
Part 1a and Part 1b: 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 14 months
Primary outcome
Part 1a and Part 1b: 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 14 months
Primary outcome
Part 1a and Part 1b: Duration of exposure to each study drug
The duration of exposure (in months) to Tulmimetostat and JSB462 (Part 1a and Part 1b) will be summarized by means of descriptive statistics
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 14 months
Primary outcome
Part 1b and Part 2: prostate-specific antigen 50 (PSA50) at Month 6
PSA50 is defined as a PSA reduction of at least 50% from baseline at 6 months confirmed by a second PSA measurement ≥ 3 weeks later.
Time frame Month 6
Secondary outcome
Part 1a and Part 1b: Plasma concentrations of tulmimetostat and JSB462
Tulmimetostat and JSB462 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 (predose/0 hour, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours; Tulmimetostat only: 30 minutes and 3 hours). Cycle 1: Day 2 (24 hours), Days 8 and 15 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
Secondary outcome
Part 2: Plasma concentrations of tulmimetostat and JSB462
Tulmimetostat and JSB462 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms
Time frame Cycle 1 and 2: Day 1 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
Secondary outcome
Part 1a and Part 1b: AUC of tulmimetostat and JSB462
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) and Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) will be listed and summarized using descriptive statistics.
Time frame Cycle 1-2: Day 1 (predose/0 hour, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours; Tulmimetostat only: 30 minutes and 3 hours). Cycle 1: Day 2 (24 hours), Days 8 and 15 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
Secondary outcome
Part 2: AUC of tulmimetostat and JSB462
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) and Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) will be listed and summarized using descriptive statistics.
Time frame Cycle 1 and 2: Day 1 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
Secondary outcome
Part 1a and Part 1b: Cmax of tulmimetostat and JSB462
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 (predose/0 hour, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours; Tulmimetostat only: 30 minutes and 3 hours). Cycle 1: Day 2 (24 hours), Days 8 and 15 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
Secondary outcome
Part 2: Cmax of tulmimetostat and JSB462
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 and 2: Day 1 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
Secondary outcome
Part 1b and Part 2: prostate-specific antigen 50 (PSA50) at 3, 9, and 12 months
PSA50 is defined as a PSA reduction of at least 50% from baseline at 3, 9, and 12 months confirmed by a second PSA measurement ≥ 3 weeks later.
Time frame Month 3, Month 9, Month 12
Secondary outcome
Part 1b and Part 2: radiographic progression free survival (rPFS)
rPFS is defined as 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 15 months
Secondary outcome
Part 1b and Part 2: overall survival (OS)
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 15 months
Secondary outcome
Part 1b and Part 2: objective response (OR)
OR is defined as a confirmed complete response (CR) or partial response (PR) per PCWG3-modified RECIST 1.1 as assessed by the investigator
Time frame From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 15 months
Secondary outcome
Part 1b and Part 2: best overall response (BOR)
BOR is defined as the best response 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 progression or date of death from any cause, whichever come first, assessed up to approximately 15 months
Secondary outcome
Part 1b and Part 2: duration of response (DOR)
DOR is defined as time between first documented CR/PR and disease progression or death due to any cause per PCWG3-modified RECIST 1.1 as assessed by the investigator
Time frame From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 15 months
Secondary outcome
Part 1b and Part 2: time to first symptomatic skeletal event (TTSSE)
TTSSE is defined as 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 15 months.
Secondary outcome
Part 2: 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 15 months
Secondary outcome
Part 2: 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 15 months
Secondary outcome
Part 2: 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 15 months
Secondary outcome
Part 2: Duration of exposure to each study drug
The duration of exposure (in months) to Tulmimetostat and JSB462 / Standard of Care (SoC) of investigator's choice (Part 2) will be summarized within each strata by means of descriptive statistics
Time frame From date of randomization till 30 days safety fup, assessed up to approximately 15 months

Dates

Dates
Start date	October 15, 2025 (actual)
Primary completion	November 9, 2029 (estimated)
Completion	December 1, 2030 (estimated)
First posted	October 3, 2025 (actual)
Last updated	September 18, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

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

Locations

35 sites are recruiting

Australia

Australia
Facility	City	State or region	Status
Novartis Investigative Site	Liverpool		Recruiting
Novartis Investigative Site	Melbourne	Victoria	Recruiting
Novartis Investigative Site	St Leonards	New South Wales	Recruiting

Canada

Canada
Facility	City	State or region	Status
Novartis Investigative Site	Halifax	Nova Scotia	Recruiting

China

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

Denmark

Denmark
Facility	City	Status
Novartis Investigative Site	Herlev	Recruiting
Novartis Investigative Site	Odense C	Recruiting
Novartis Investigative Site	Vejle	Recruiting

France

France
Facility	City	Status
Novartis Investigative Site	Bordeaux	Recruiting
Novartis Investigative Site	Paris	Recruiting
Novartis Investigative Site	Paris	Recruiting

Germany

Germany
Facility	City	State or region	Status
Novartis Investigative Site	Düsseldorf	North Rhine-Westphalia	Recruiting
Novartis Investigative Site	Jena	Thuringia	Recruiting

Italy

Italy
Facility	City	State or region	Status
Novartis Investigative Site	Milan	MI	Recruiting
Novartis Investigative Site	Orbassano	TO	Recruiting
Novartis Investigative Site	Padova	PD	Recruiting

Malaysia

Malaysia
Facility	City	State or region	Status
Novartis Investigative Site	Kuching	Sarawak	Recruiting

Mexico

Mexico
Facility	City	State or region	Status
Novartis Investigative Site	Tlalpan	Mexico City	Recruiting

Poland

Poland
Facility	City	State or region	Status
Novartis Investigative Site	Poznan		Recruiting

Singapore

Singapore
Facility	City	State or region	Status
Novartis Investigative Site	Singapore		Recruiting
Novartis Investigative Site	Singapore		Recruiting

Spain

Spain
Facility	City	State or region	Status
Novartis Investigative Site	L'Hospitalet de Llobregat	Barcelona	Recruiting
Novartis Investigative Site	Madrid		Recruiting
Novartis Investigative Site	Madrid		Recruiting
Novartis Investigative Site	Santiago Compostela	A Coruna	Recruiting

United Kingdom

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

United States

United States
Facility	City	State or region	Status
Emory University	Atlanta	Georgia	Recruiting
Mass General Hospital	Boston	Massachusetts	Recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	Recruiting
Sarah Cannon Research Institute	Denver	Colorado	Recruiting
Duke University Medical Center	Durham	North Carolina	Recruiting
Sarah Cannon Research Institute	Jacksonville	Florida	Recruiting
Fred Hutchinson Cancer Research Center	Seattle	Washington	Recruiting
Wichita Urology Group PA	Wichita	Kansas	Recruiting

Study documents

No documents are linked in this registry record.

Changes over time

August 21, 2026
Site added
1 site added (35 total)
3435
August 18, 2026
Site added
1 site added (34 total)
3334

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

https://xmedica.io/trials/ctgov/NCT07206056

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

Canada

China

Denmark

France

Germany

Italy

Malaysia

Mexico

Poland

Singapore

Spain

United Kingdom

United States

Study documents

Changes over time