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Tulmimetostat and Luxdegalutamide for Progressive Metastatic Castrate Resistant Prostate Cancer

This study is testing a combination of two drugs, tulmimetostat (DZR123) and luxdegalutamide (JSB462), for men with progressive metastatic castrate resistant prostate cancer (mCRPC). This is prostate cancer that has spread and is no longer responding to treatments that lower testosterone. The study aims to find the safest and most effective dose of these drugs when given together. Researchers will also compare this drug combination to standard treatments to see if it improves how well the cancer responds. You may be eligible if you are an adult man, 18 years or older, with confirmed adenocarcinoma of the prostate. The study is currently unclear on its recruitment status and plans to enroll 188 participants.

Study design
This is an open-label (meaning you and your doctors will know which treatment you are receiving) Phase I/II study. It will involve finding the right dose of the drugs and then comparing the combination to standard care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be followed up to 30 days after treatment, with assessments up to approximately 14 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07206056

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~188 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Tulmimetostat DL1 QDTulmimetostat DL2 QDTulmimetostat DL3 QDTulmimetostat Doses 1 or 2 QDTulmimetostat RP2D QDJSB462 Dose 1 QD

At a glance

Recruiting sites
35 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1a: Dose-limiting toxicities (DLTs)
Measured over Up to 28 days
+5 more outcomes measured

Conditions

Progressive Metastatic Castrate Resistant Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

35 sites across 29 states
Denmark3
France3
Singapore2
Spain2
Colorado1
Florida1
Georgia1
Kansas1

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Part 1a: Dose-limiting toxicities (DLTs)Up to 28 days

    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).

  • Part 1a and Part 1b: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)From date of randomization till 30 days safety fup, assessed up to approximately 14 months

    The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.

  • Part 1a and Part 1b: Number of Participants with dose adjustmentsFrom date of randomization till 30 days safety fup, assessed up to approximately 14 months

    The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.

  • Part 1a and Part 1b: Dose IntensityFrom date of randomization till 30 days safety fup, assessed up to approximately 14 months

    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

  • Part 1a and Part 1b: Duration of exposure to each study drugFrom date of randomization till 30 days safety fup, assessed up to approximately 14 months

    The duration of exposure (in months) to Tulmimetostat and JSB462 (Part 1a and Part 1b) will be summarized by means of descriptive statistics

  • Part 1b and Part 2: prostate-specific antigen 50 (PSA50) at Month 6Month 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.