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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)

NCT ID: NCT07206056

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2030-12-17

Brief Summary

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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).

Detailed Description

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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

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Progressive Metastatic Castrate Resistant Prostate Cancer

Keywords

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metastatic castrate resistant prostate cancer (mCRPC) tulmimetostat (DZR123) luxdegalutamide (JSB462) Androgen Deprivation Therapy (ADT) Standard of care (SoC) TulmiSTAR-01

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part 1a (dose escalation): Participants will be assigned to cohorts to receive study treatment (tulmimetostat and JSB462) at different provisional dose levels.

Part 1b (dose expansion and optimization): Participants will be randomized in a ratio and receive study treatment as:

* Arm A: Tulmimetostat Dose 1 QD + JSB462 QD
* Arm B: Tulmimetostat Dose 2 QD + JSB462 QD

Part 2: Participants will be randomized in a ratio and receive study treatment as:

* Arm 1: Tulmimetostat RP2D QD + JSB462 (either Dose 1 or Dose 2 QD)
* Arm 2 (Control): SoC (ARPI, chemotherapy, Pluvicto) at the discretion of the investigator
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1a: Cohort DL1A

Tulmimetostat DL1 QD + JSB462 Dose 1 QD

Group Type EXPERIMENTAL

Tulmimetostat DL1 QD

Intervention Type DRUG

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))

JSB462 Dose 1 QD

Intervention Type DRUG

JSB462 Dose 1 QD

Part 1a: Cohort DL1B

Tulmimetostat DL1 QD + JSB462 Dose 2 QD

Group Type EXPERIMENTAL

Tulmimetostat DL1 QD

Intervention Type DRUG

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))

JSB462 Dose 2 QD

Intervention Type DRUG

JSB462 Dose 2 QD

Part 1a: Cohort DL2A

Tulmimetostat DL2 QD + JSB462 Dose 1 QD

Group Type EXPERIMENTAL

Tulmimetostat DL2 QD

Intervention Type DRUG

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))

JSB462 Dose 1 QD

Intervention Type DRUG

JSB462 Dose 1 QD

Part 1a: Cohort DL2B

Tulmimetostat DL2 QD + JSB462 Dose 2 QD

Group Type EXPERIMENTAL

Tulmimetostat DL2 QD

Intervention Type DRUG

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))

JSB462 Dose 2 QD

Intervention Type DRUG

JSB462 Dose 2 QD

Part 1a: Cohort DL3A

Tulmimetostat DL3 QD + JSB462 Dose 1 QD

Group Type EXPERIMENTAL

Tulmimetostat DL3 QD

Intervention Type DRUG

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))

JSB462 Dose 1 QD

Intervention Type DRUG

JSB462 Dose 1 QD

Part 1a: Cohort DL3B

Tulmimetostat DL3 QD + JSB462 Dose 2 QD

Group Type EXPERIMENTAL

Tulmimetostat DL3 QD

Intervention Type DRUG

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))

JSB462 Dose 2 QD

Intervention Type DRUG

JSB462 Dose 2 QD

Part 1b : Arm A

Tulmimetostat Dose 1 QD + JSB462 QD

Group Type EXPERIMENTAL

Tulmimetostat Doses 1 or 2 QD

Intervention Type DRUG

Part 1b (dose expansion and optimization):

tulmimetostat doses 1 or 2 QD

JSB462 QD

Intervention Type DRUG

The dose of JSB462 QD will be determined based on the totality of data from Part 1a

Part 1b: Arm B

Tulmimetostat Dose 2 QD + JSB462 QD

Group Type EXPERIMENTAL

Tulmimetostat Doses 1 or 2 QD

Intervention Type DRUG

Part 1b (dose expansion and optimization):

tulmimetostat doses 1 or 2 QD

JSB462 QD

Intervention Type DRUG

The dose of JSB462 QD will be determined based on the totality of data from Part 1a

Part 2: Arm 1

Tulmimetostat RP2D QD + JSB462 QD

Group Type EXPERIMENTAL

Tulmimetostat RP2D QD

Intervention Type DRUG

Part 2:

tulmimetostat Recommended Phase 2 Dose (RP2D) QD

JSB462 QD

Intervention Type DRUG

The dose of JSB462 QD will be determined based on the totality of data from Part 1a

Part 2: Arm 2

Standard of Care at the discretion of the investigator

Group Type ACTIVE_COMPARATOR

Standard of Care (SoC)

Intervention Type DRUG

Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator

Interventions

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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))

Intervention Type 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))

Intervention Type 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))

Intervention Type DRUG

Tulmimetostat Doses 1 or 2 QD

Part 1b (dose expansion and optimization):

tulmimetostat doses 1 or 2 QD

Intervention Type DRUG

Tulmimetostat RP2D QD

Part 2:

tulmimetostat Recommended Phase 2 Dose (RP2D) QD

Intervention Type DRUG

JSB462 Dose 1 QD

JSB462 Dose 1 QD

Intervention Type DRUG

JSB462 Dose 2 QD

JSB462 Dose 2 QD

Intervention Type DRUG

JSB462 QD

The dose of JSB462 QD will be determined based on the totality of data from Part 1a

Intervention Type DRUG

Standard of Care (SoC)

Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator

Intervention Type DRUG

Other Intervention Names

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DZR123 DZR123 DZR123 DZR123 DZR123 luxdegalutamide luxdegalutamide luxdegalutamide

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Sarah Cannon Research Institute

Denver, Colorado, United States

Site Status RECRUITING

Sarah Cannon Research Institute

Jacksonville, Florida, United States

Site Status RECRUITING

Wichita Urology Group PA

Wichita, Kansas, United States

Site Status RECRUITING

Novartis Investigative Site

St Leonards, New South Wales, Australia

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Countries

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United States Australia Singapore

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Facility Contacts

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Role: primary

Marissa Lisle

Role: primary

Connie Manon

Role: primary

Other Identifiers

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2025-521880-10-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDZR123A12107

Identifier Type: -

Identifier Source: org_study_id