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PHASE1RECRUITING

Comparing 10 approaches for progressive metastatic castrate resistant prostate cancer

Official title: 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

Condition: Progressive Metastatic Castrate Resistant Prostate CancerSponsor: Novartis PharmaceuticalsTarget enrollment: 188

Interventions

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

DRUG

JSB462 Dose 1 QD

DRUG

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

Canadian Sites (1)

Novartis Investigative Site

Halifax, Nova Scotia, Canada

RECRUITING

See who this study is looking for20 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+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 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, 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

−Known hypersensitivity or contraindication to any of the study treatment components or its excipients or to drugs of similar chemical classes.
−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.
−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.
−Other protocol-defined inclusion/exclusion criteria may apply.
−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.

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 1/2 — a combined study that starts with early safety and continues into what the treatment does.

What is being given or done in this study: Tulmimetostat DL1 QD, Tulmimetostat DL2 QD, Tulmimetostat DL3 QD, Tulmimetostat Doses 1 or 2 QD, and 5 more.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases
armsInterventionsModule.interventions[].name

How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-label: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

One group receives an existing treatment, so the two can be compared.

There are 10 groups in this study.

From the trial registry

Built from this field:

armsInterventionsModule.armGroups[].type

Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study lists male participants only.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.minimumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 188 people.

The study is currently expected to finish around December 2030.

The main measurement is taken over: Up to 28 days.

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Part 1a: Dose-limiting toxicities (DLTs) — measured over Up to 28 days.

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

Part 1a and Part 1b: Number of Participants with dose adjustments — measured over From date of randomization till 30 days safety fup, assessed up to approximately 14 months.

Part 1a and Part 1b: Dose Intensity — measured over From date of randomization till 30 days safety fup, assessed up to approximately 14 months.

The study lists 2 further main measurements.

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07206056 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Tulmimetostat DL1 QDDrug

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))