NCT07206056ClinicalTrials.gov
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
باختصار
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).
المرحلة 1 / المرحلة 2مطلوب 188 مشاركاً35 موقعاً14 دولة
الفئات
مسجَّلة في سجل واحد
- ClinicalTrials.govNCT07206056فتح هذا السجل في ClinicalTrials.govتمت المزامنة أول أمس
يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.
تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.
هل أنت مهتم بهذه الدراسة؟
تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.
How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2025-10-03; recorded start 2025-10-15
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Not stated: Open label (no blinding)Masking is recorded as none (open label)
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 1128 other studies in this databaseCounted from the lead sponsor named in the record (Novartis Pharmaceuticals)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: industry.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A strong methodological design for a phase 2 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding0/20
Open-label
- Control arm15/15
Active-comparator control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre8/8
Multi-centre: 33 sites
- Data monitoring committee0/7
No data monitoring committee stated
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A medium-sized study, international in scope: 188 participants (target), run at 35 sites, across 14 countries.
How this score is built
- Enrolment22/40
188 participants (target)
- Site count18/25
33 sites
- Country count12/15
14 countries
- Planned duration10/10
Planned over about 62 months
- Sponsor scale10/10
Novartis Pharmaceuticals has led 1,104 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
ملخص
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).
الحالات
- Progressive Metastatic Castrate Resistant Prostate Cancer
الأهلية
| الجنس | ذكر |
|---|---|
| الأعمار | 18 Years – لا حد أقصى |
| المتطوعون الأصحّاء | لا |
الأهلية كما كُتبت في السجل
الأهلية في عبارات بسيطة
لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.
تصميم الدراسة
| نوع الدراسة | تدخّلية |
|---|---|
| المرحلة | المرحلة 1 / المرحلة 2 |
| التخصيص | معشّاة |
| نموذج التدخّل | PARALLEL |
| الغرض الأساسي | TREATMENT |
| التعمية | NONE (0) |
| التجنيد | مطلوب 188 مشاركاً |
الجهة الراعية والمتعاونون
- Novartis Pharmaceuticals الجهة الراعية
الأذرع والتدخلات
- Part 2: Arm 2ACTIVE_COMPARATOR
Standard of Care at the discretion of the investigator
- Part 1b : Arm AEXPERIMENTAL
Tulmimetostat Dose 1 QD + JSB462 QD
- Part 1b: Arm BEXPERIMENTAL
Tulmimetostat Dose 2 QD + JSB462 QD
- Part 1a: Cohort DL1AEXPERIMENTAL
Tulmimetostat DL1 QD + JSB462 Dose 1 QD
- Part 1a: Cohort DL1BEXPERIMENTAL
Tulmimetostat DL1 QD + JSB462 Dose 2 QD
- Part 1a: Cohort DL2AEXPERIMENTAL
Tulmimetostat DL2 QD + JSB462 Dose 1 QD
- Part 1a: Cohort DL2BEXPERIMENTAL
Tulmimetostat DL2 QD + JSB462 Dose 2 QD
- Part 1a: Cohort DL3AEXPERIMENTAL
Tulmimetostat DL3 QD + JSB462 Dose 1 QD
- Part 1a: Cohort DL3BEXPERIMENTAL
Tulmimetostat DL3 QD + JSB462 Dose 2 QD
- Part 2: Arm 1EXPERIMENTAL
Tulmimetostat RP2D QD + JSB462 QD
التدخلات
- دواء JSB462 Dose 1 QD
JSB462 Dose 1 QD
- دواء JSB462 Dose 2 QD
JSB462 Dose 2 QD
- دواء JSB462 QD
The dose of JSB462 QD will be determined based on the totality of data from Part 1a
- دواء Standard of Care (SoC)
Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator
- دواء 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))
- دواء 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))
- دواء 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))
- دواء Tulmimetostat Doses 1 or 2 QD
Part 1b (dose expansion and optimization): tulmimetostat doses 1 or 2 QD
- دواء Tulmimetostat RP2D QD
Part 2: tulmimetostat Recommended Phase 2 Dose (RP2D) QD
مقاييس النتائج
مقياس النتيجة الأولي
Part 1a: Dose-limiting toxicities (DLTs)
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).
الإطار الزمني Up to 28 days
مقياس النتيجة الأولي
Part 1a and Part 1b: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 14 months
مقياس النتيجة الأولي
Part 1a and Part 1b: Number of Participants with dose adjustments
The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.
الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 14 months
مقياس النتيجة الأولي
Part 1a and Part 1b: Dose Intensity
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
الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 14 months
مقياس النتيجة الأولي
Part 1a and Part 1b: Duration of exposure to each study drug
The duration of exposure (in months) to Tulmimetostat and JSB462 (Part 1a and Part 1b) will be summarized by means of descriptive statistics
الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 14 months
مقياس النتيجة الأولي
Part 1b and Part 2: prostate-specific antigen 50 (PSA50) at Month 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.
الإطار الزمني Month 6
مقياس النتيجة الثانوي
Part 1a and Part 1b: Plasma concentrations of tulmimetostat and JSB462
Tulmimetostat and JSB462 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms
الإطار الزمني Cycle 1-2: Day 1 (predose/0 hour, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours; Tulmimetostat only: 30 minutes and 3 hours). Cycle 1: Day 2 (24 hours), Days 8 and 15 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
مقياس النتيجة الثانوي
Part 2: Plasma concentrations of tulmimetostat and JSB462
Tulmimetostat and JSB462 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms
الإطار الزمني Cycle 1 and 2: Day 1 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
مقياس النتيجة الثانوي
Part 1a and Part 1b: AUC of tulmimetostat and JSB462
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) and Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) will be listed and summarized using descriptive statistics.
الإطار الزمني Cycle 1-2: Day 1 (predose/0 hour, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours; Tulmimetostat only: 30 minutes and 3 hours). Cycle 1: Day 2 (24 hours), Days 8 and 15 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
مقياس النتيجة الثانوي
Part 2: AUC of tulmimetostat and JSB462
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) and Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) will be listed and summarized using descriptive statistics.
الإطار الزمني Cycle 1 and 2: Day 1 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
مقياس النتيجة الثانوي
Part 1a and Part 1b: Cmax of tulmimetostat and JSB462
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
الإطار الزمني Cycle 1-2: Day 1 (predose/0 hour, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours; Tulmimetostat only: 30 minutes and 3 hours). Cycle 1: Day 2 (24 hours), Days 8 and 15 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
مقياس النتيجة الثانوي
Part 2: Cmax of tulmimetostat and JSB462
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
الإطار الزمني Cycle 1 and 2: Day 1 (predose/0 hour and 2 hours). Cycles 3-5: Day 1 (predose/0 hour). 1 cycle = 28 days.
مقياس النتيجة الثانوي
Part 1b and Part 2: prostate-specific antigen 50 (PSA50) at 3, 9, and 12 months
PSA50 is defined as a PSA reduction of at least 50% from baseline at 3, 9, and 12 months confirmed by a second PSA measurement ≥ 3 weeks later.
الإطار الزمني Month 3, Month 9, Month 12
مقياس النتيجة الثانوي
Part 1b and Part 2: radiographic progression free survival (rPFS)
rPFS is defined as time between randomization and the first occurrence of disease progression as per PCWG3-modified RECIST v1.1 or death due to any cause
الإطار الزمني From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 15 months
مقياس النتيجة الثانوي
Part 1b and Part 2: overall survival (OS)
OS is defined as the time between randomization to date of death due to any cause
الإطار الزمني From date of randomization until date of death from any cause, assessed up to approximately 15 months
مقياس النتيجة الثانوي
Part 1b and Part 2: objective response (OR)
OR is defined as a confirmed complete response (CR) or partial response (PR) per PCWG3-modified RECIST 1.1 as assessed by the investigator
الإطار الزمني From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 15 months
مقياس النتيجة الثانوي
Part 1b and Part 2: best overall response (BOR)
BOR is defined as the best response per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1 as assessed by the Investigator
الإطار الزمني From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 15 months
مقياس النتيجة الثانوي
Part 1b and Part 2: duration of response (DOR)
DOR is defined as time between first documented CR/PR and disease progression or death due to any cause per PCWG3-modified RECIST 1.1 as assessed by the investigator
الإطار الزمني From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 15 months
مقياس النتيجة الثانوي
Part 1b and Part 2: time to first symptomatic skeletal event (TTSSE)
TTSSE is defined as time from randomization to the first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first.
الإطار الزمني From randomization until the first occurrence of a new symptomatic bone fracture, spinal cord compression, tumor-related orthopedic surgery, radiation therapy for bone pain, or death, assessed up to 15 months.
مقياس النتيجة الثانوي
Part 2: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 15 months
مقياس النتيجة الثانوي
Part 2: Number of Participants with dose adjustments
The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.
الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 15 months
مقياس النتيجة الثانوي
Part 2: Dose Intensity
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
الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 15 months
مقياس النتيجة الثانوي
Part 2: Duration of exposure to each study drug
The duration of exposure (in months) to Tulmimetostat and JSB462 / Standard of Care (SoC) of investigator's choice (Part 2) will be summarized within each strata by means of descriptive statistics
الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 15 months
التواريخ
| تاريخ البدء | 15 أكتوبر 2025 (فعلي) |
|---|---|
| الإتمام الأولي | 9 نوفمبر 2029 (تقديري) |
| الإتمام | 1 ديسمبر 2030 (تقديري) |
| أول نشر | 3 أكتوبر 2025 (فعلي) |
| آخر تحديث | 18 سبتمبر 2026 |
| النتائج منشورة | غير مذكور في سجل السجل |
| آخر تأكيد للحالة | سبتمبر 2026 |
فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.
المواقع
35 موقعاً قيد التجنيد
Australia
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | Liverpool | قيد التجنيد | |
| Novartis Investigative Site | Melbourne | Victoria | قيد التجنيد |
| Novartis Investigative Site | St Leonards | New South Wales | قيد التجنيد |
Canada
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | Halifax | Nova Scotia | قيد التجنيد |
China
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | Beijing | قيد التجنيد |
Denmark
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | Herlev | قيد التجنيد | |
| Novartis Investigative Site | Odense C | قيد التجنيد | |
| Novartis Investigative Site | Vejle | قيد التجنيد |
France
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | Bordeaux | قيد التجنيد | |
| Novartis Investigative Site | Paris | قيد التجنيد | |
| Novartis Investigative Site | Paris | قيد التجنيد |
Germany
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | Düsseldorf | North Rhine-Westphalia | قيد التجنيد |
| Novartis Investigative Site | Jena | Thuringia | قيد التجنيد |
Italy
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | Milan | MI | قيد التجنيد |
| Novartis Investigative Site | Orbassano | TO | قيد التجنيد |
| Novartis Investigative Site | Padova | PD | قيد التجنيد |
Malaysia
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | Kuching | Sarawak | قيد التجنيد |
Mexico
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | Tlalpan | Mexico City | قيد التجنيد |
Poland
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | Poznan | قيد التجنيد |
Singapore
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | Singapore | قيد التجنيد | |
| Novartis Investigative Site | Singapore | قيد التجنيد |
Spain
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | L'Hospitalet de Llobregat | Barcelona | قيد التجنيد |
| Novartis Investigative Site | Madrid | قيد التجنيد | |
| Novartis Investigative Site | Madrid | قيد التجنيد | |
| Novartis Investigative Site | Santiago Compostela | A Coruna | قيد التجنيد |
United Kingdom
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Novartis Investigative Site | London | قيد التجنيد | |
| Novartis Investigative Site | Sutton | Surrey | قيد التجنيد |
United States
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Emory University | Atlanta | Georgia | قيد التجنيد |
| Mass General Hospital | Boston | Massachusetts | قيد التجنيد |
| Cleveland Clinic Foundation | Cleveland | Ohio | قيد التجنيد |
| Sarah Cannon Research Institute | Denver | Colorado | قيد التجنيد |
| Duke University Medical Center | Durham | North Carolina | قيد التجنيد |
| Sarah Cannon Research Institute | Jacksonville | Florida | قيد التجنيد |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | قيد التجنيد |
| Wichita Urology Group PA | Wichita | Kansas | قيد التجنيد |
مستندات الدراسة
لا تُرتبط أي مستندات في سجل السجل هذا.
التغيّرات عبر الزمن
- 21 أغسطس 2026
أُضيف موقع
1 site added (35 total)
3435
- 18 أغسطس 2026
أُضيف موقع
1 site added (34 total)
3334