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Looking for participantsPhase1/Phase2

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)

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT07206056

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Tulmimetostat DL1 QD (drug), Tulmimetostat DL2 QD (drug), Tulmimetostat DL3 QD (drug), Tulmimetostat Doses 1 or 2 QD (drug)
How long the study runs
Study runs about 62 months (dates as stated)
About the drug or intervention
Tulmimetostat DL1 QD — 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)) · Tulmimetostat DL2 QD — 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)) · Tulmimetostat DL3 QD — 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)) · Tulmimetostat Doses 1 or 2 QD — drug: Part 1b (dose expansion and optimization): tulmimetostat doses 1 or 2 QD · Tulmimetostat RP2D QD — drug: Part 2: tulmimetostat Recommended Phase 2 Dose (RP2D) QD · JSB462 Dose 1 QD — drug: JSB462 Dose 1 QD · JSB462 Dose 2 QD — drug: JSB462 Dose 2 QD · JSB462 QD — drug: The dose of JSB462 QD will be determined based on the totality of data from Part 1a · Standard of Care (SoC) — drug: Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
188
Started
2025-10-15
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for progressive metastatic castrate resistant prostate cancer
  • • Phase1/Phase2 - 188 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with progressive metastatic castrate resistant prostate cancer
  • • Male only

Where?

  • • Sutton - Novartis Investigative Site
  • • London - Novartis Investigative Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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.

Progressive Metastatic Castrate Resistant Prostate Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

Biomarkers mentioned

PSA

Treatment history

Treatments you must have had:

  • ✓ progressive mCRPC
  • ✓ a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1
  • ✓ of chemotherapy in CRPC setting

What the study is looking for

  • ✓Participant is an adult man ≥ 18 years of age.
  • ✓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,...

Who cannot take part

  • ✗Previous treatment with any PRC2 inhibitor, including but not limited to EZH2 inhibitors, EZH2/1 inhibitors, or...
  • ✗Previous treatment with a protein degrader compound that targets the AR.
  • ✗Known hypersensitivity or safety concern to any of the study treatment components or its excipients or to drugs of...
  • ✗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...
See the full criteria
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.

Where Is This Study? (2 UK sites)

Novartis Investigative Site

Sutton SM2 5PT, United Kingdom

Recruiting

Novartis Investigative Site

London W1G 6AD, United Kingdom

Recruiting

How to Get in Touch

Novartis Pharmaceuticals

Sponsor contact

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

Sponsor contact

CONTACT

+41613241111 novartis.email@novartis.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10