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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (2 UK sites)
Novartis Investigative Site
Sutton SM2 5PT, United Kingdom
Novartis Investigative Site
London W1G 6AD, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT
