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NCT07190300ClinicalTrials.gov

TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

المرحلة 1 / المرحلة 2مطلوب 181 مشاركاً31 موقعاً14 دولة

الفئات

علم الأورام51%الكلى والمسالك البولية19%الغدد الصمّاء والأيض16%طب الأعصاب7%الأمراض النادرة والوراثية7%

مسجَّلة في سجل واحد

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هل أنت مهتم بهذه الدراسة؟

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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.

  • Registered before enrolment beganFirst posted 2025-09-24; recorded start 2026-01-13
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • 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.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1128 other studies in this databaseCounted from the lead sponsor named in the record (Novartis Pharmaceuticals)
  • 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.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

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.

Methodological rigourDEFINITIVE

A definitive-grade 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

  • Blinding20/20

    Quadruple-blind

  • 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: 31 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

ScaleMEDIUM

A medium-sized study, international in scope: 181 participants (target), run at 31 sites, across 14 countries.

How this score is built
  • Enrolment21/40

    181 participants (target)

  • Site count18/25

    31 sites

  • Country count12/15

    14 countries

  • Planned duration10/10

    Planned over about 80 months

  • Sponsor scale10/10

    Novartis Pharmaceuticals has led 1,104 trials in our corpus

Investigator standingUNKNOWN

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

The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

The study consists of two phases: 1. Phase I: The Phase I part includes two groups: Part 1 will assess the combination of tulmimetostat with darolutamide (Group A), and Part 2 will assess tulmimetostat with abiraterone (Group B). The primary objective of Phase I is to determine the recommended dose escalations (RDEs) for each combination, with enrollment using a staggered approach between groups. Participants in both groups will continue androgen deprivation therapy (ADT) to maintain castrate testosterone levels (\<50 ng/dL or \<1.7 nmol/L), as determined by the investigator based on local guidelines. In Group B, abiraterone will be administered with an oral corticosteroid (prednisone or prednisolone) per local prescribing information. 2. Phase II: Phase II is a randomized, open-label, multicenter dose-expansion study to further evaluate the recommended dose(s) of tulmimetostat in combination with darolutamide and provide proof-of-concept for efficacy and safety. Participants will be randomized to receive tulmimetostat plus darolutamide or darolutamide alone. Eligible participants include those with metastatic hormone-sensitive prostate cancer (mHSPC) who are either de novo or recurrent, without prior radioligand therapy, but who may have received prior taxane-based chemotherapy and/or androgen receptor pathway inhibitors (ARPIs), excluding darolutamide. The study evaluates tulmimetostat-based combinations as potential treatment options for men with mHSPC. The study for each participant consists of a screening period, a study treatment period followed by a post treatment long-term follow-up.

الحالات

  • Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

الأهلية

الجنسذكر
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

Key Inclusion Criteria: * Adult men ≥ 18 years old with de novo or recurrent mHSPC (without neuroendocrine or small cell features). The tumor lesion(s) may be located in the bone, soft tissue/visceral region, or both. * Participants must have castrate levels of testosterone, i.e., ≤ 50 ng/dL (≤ 1.7 nM). * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Adequate bone marrow and organ function * Prior ADT: Participants must have started ADT at least 1 month (at least 28 days) but no more than 12 months before study entry and be willing to continue ADT during treatment * Prior taxane use for mHSPC is permitted: \~ Phase I and II: Participants may have received, but not progressed on, one prior taxane-based therapy. Phase II: Limited to 25% participants with prior taxane use. * Prior ARPI is allowed in both Phase I and Phase II: 1. Prior ARPI use in biochemical recurrence (BCR) or curative treatment is allowed for any duration, provided therapy was discontinued and participant had no evidence of conventional imaging positive metastatic disease at that time 2. Prior ARPI use in mHSPC is permitted but not mandated. - If participants meet all study eligibility criteria, they are required to stop their prior ARPI after providing informed consent and remain off ARPI until Cycle 1 Day 1, when study treatment is initiated. * Phase I: Allowed for any duration. * Phase II: Allowed prior exposure to ARPI is ≤4 months. * Phase II: Participants with ongoing use of darolutamide are not eligible. Participants with ongoing ARPI are eligible for a switch from their ongoing ARPI therapy if they have not progressed to CRPC disease, and meet any of the criteria, indicative of suboptimal biochemical response, or intolerability, as assessed by the Investigator. * Other permitted prior local therapy for mHSPC: * Phase I and II: Prior prostate-directed radiation or surgical intervention. Radiation must be completed before study entry; surgery at least 2 weeks prior. Key Exclusion Criteria: * 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 the start of study treatment. * Participants who have not received ARPI treatment for mHSPC and present with PSA levels of ≤0.5 ng/mL or those with prior/ongoing ARPI treatment presenting with PSA levels of ≤ 0.2 ng/mL prior to treatment assignment/randomization. * Participants with CNS metastases are excluded unless: * they have received prior therapy (e.g. surgery, radiotherapy, gamma knife), are neurologically stable and asymptomatic. * they are not receiving corticosteroid for the purpose of maintaining neurologic integrity and have baseline and subsequent radiological imaging of the brain. * Concurrent use of first-generation anti-androgens (like bicalutamide). Prior use of a first-generation anti-androgen drug in the context of ADT initiation with a GNRH analog is allowed, provided it was administered for ≤14 days and the last dose was administered ≥7 days from the study entry. * Systemic ketoconazole is used as antineoplastic treatment for prostate cancer. * Previous exposure to radioligand therapy. * Treatment with any investigational agent within 28 days (or 5 half-lives, whichever is longer) prior to study entry. * Previous treatment with any Polycomb Repressive Complex 2 (PRC2) inhibitor, including but not limited to Enhancer of Zeste Homolog 2 (EZH2) inhibitors, EZH2/1 inhibitors, or embryonic ectoderm development (EED) inhibitors. * Herbal products that may decrease PSA levels within 4 weeks prior to the start of study drug treatment and while on study. * Participants taking prohibited medication(s) (e.g., strong CYP3A4 inducers or strong or moderate CYP3A4 inhibitors that cannot be stopped within 7 days or 5 half-lives (whichever is longer) prior to study treatment and for the duration of the study treatment or prohibited herbal product(s) that cannot be stopped 7 days prior to study treatment. Other inclusion/exclusion criteria may apply

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 1 / المرحلة 2
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 181 مشاركاً

الجهة الراعية والمتعاونون

  • Novartis Pharmaceuticals الجهة الراعية

الأذرع والتدخلات

  • Phase II: Arm 2EXPERIMENTAL

    Tulmimetostat dose 2 PO + Darolutamide 600 mg PO BID

  • Phase II: Arm 3ACTIVE_COMPARATOR

    Darolutamide 600 mg PO BID

  • Phase I: Group A (part 1)EXPERIMENTAL

    Tulmimetostat oral (PO) once a day (QD) escalating doses + Darolutamide 600 mg twice a day (BID)

  • Phase I: Group B (part 2)EXPERIMENTAL

    Tulmimetostat PO QD escalating doses + Abiraterone 1000 mg PO QD

  • Phase II: Arm 1EXPERIMENTAL

    Tulmimetostat dose 1 PO + Darolutamide 600 mg PO BID

التدخلات

  • دواء Abiraterone

    1000 mg is administered orally QD

  • دواء Darolutamide

    600 mg is administered orally BID

  • دواء Tulmimetostat

    Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s))

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Phase I (Group A and Group B): Dose-limiting toxicities (DLTs)

    A dose-limiting toxicity is defined as an adverse event or abnormal laboratory value, not clearly due to underlying disease or extraneous causes, that occurs within the first 28 days of treatment with tulmimetostat 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

  2. مقياس النتيجة الأولي

    Phase I (Group A and Group B): 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 79 months

  3. مقياس النتيجة الأولي

    Phase I (Group A and Group B): 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 79 months

  4. مقياس النتيجة الأولي

    Phase I (Group A and Group B): 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 79 months

  5. مقياس النتيجة الأولي

    Phase I (Group A and Group B): Duration of exposure to each study drug

    Duration of exposure (in months) to each study drug will be summarized by means of descriptive statistics

    الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 79 months

  6. مقياس النتيجة الأولي

    Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL

    Prostate-Specific Antigen (PSA) response rate is defined as proportion of participants who achieved a decline in PSA to \< 0.2 ng/mL at month 6 months, confirmed by a second PSA measurement ≥ 3 weeks later.

    الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 79 months

  7. مقياس النتيجة الثانوي

    Phase I (Group A): Plasma concentrations of Tulmimetostat and Darolutamide

    Tulmimetostat and Darolutamide 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 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  8. مقياس النتيجة الثانوي

    Phase I (Group A): AUC of Tulmimetostat and Darolutamide

    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), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics.

    الإطار الزمني Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  9. مقياس النتيجة الثانوي

    Phase I (Group A): Cmax of Tulmimetostat and Darolutamide

    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 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  10. مقياس النتيجة الثانوي

    Phase I (Group B): Plasma concentrations of Tulmimetostat and Abiraterone

    Tulmimetostat and Abiraterone 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 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Day 2 (0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  11. مقياس النتيجة الثانوي

    Phase I (Group B): AUC of Tulmimetostat and Abiraterone

    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), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics.

    الإطار الزمني Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Day 2 (0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  12. مقياس النتيجة الثانوي

    Phase I (Group B): Cmax of Tulmimetostat and Abiraterone

    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 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Day 2 (0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  13. مقياس النتيجة الثانوي

    Phase II (Group A): Radiographic progression free survival (rPFS)

    Radiographic progression free survival (rPFS) is defined as the 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 79 months

  14. مقياس النتيجة الثانوي

    Phase II (Group A):Overall survival (OS)

    Overall survival (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 79 months

  15. مقياس النتيجة الثانوي

    Phase II (Group A): Objective response (OR)

    Objective response (OR) is defined as a confirmed Complete Response (CR) or Partial Response (PR) 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 confirmed Complete Response (CR) or Partial Response (PR), assessed up to approximately 79 months

  16. مقياس النتيجة الثانوي

    Phase II (Group A): Best Overall response (BOR)

    Best Overall response (BOR) is defined as the best response per PCWG3-modified RECIST 1.1 as assessed by the Investigator from the start of the treatment until disease progression/recurrence

    الإطار الزمني From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 79 months

  17. مقياس النتيجة الثانوي

    Phase II (Group A): Duration of response (DOR)

    Duration of response (DOR) defined as time between first documented CR/PR and disease progression per PCWG3-modified RECIST 1.1 as assessed by the Investigator or death due to any cause

    الإطار الزمني From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 79 months

  18. مقياس النتيجة الثانوي

    Phase II (Group A): Prostate-Specific Antigen 50 (PSA50)

    Prostate-Specific Antigen 50 (PSA50) is defined as a ≥ 50% decrease in PSA levels from baseline at any timepoint, confirmed by a second PSA measurement ≥ 3 weeks without any PSA progression in between

    الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 79 months

  19. مقياس النتيجة الثانوي

    Phase II (Group A): Prostate-Specific Antigen (PSA) Response of <0.1 ng/mL

    Prostate-Specific Antigen (PSA) Response of \<0.1 ng/mL is defined as PSA level \< 0.1 ng/mL at any timepoint during the trial from randomization

    الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 79 months

  20. مقياس النتيجة الثانوي

    Phase II (Group A): Time to castration-resistant prostate cancer (CRPC)

    Time to castration-resistant prostate cancer (CRPC) is defined as the time from randomization to the first occurrence of one of the following events: PSA progression, radiological progression by bone lesions, or radiological progression by soft tissue and visceral lesions

    الإطار الزمني From date of randomization until date of PSA progression, radiological progression by bone lesions, or radiological progression by soft tissue and visceral lesions, whichever comes first, assessed up to approximately 79 months

  21. مقياس النتيجة الثانوي

    Phase II (Group A): 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 79 months

  22. مقياس النتيجة الثانوي

    Phase II (Group A): 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 79 months

  23. مقياس النتيجة الثانوي

    Phase II (Group A): 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 79 months

  24. مقياس النتيجة الثانوي

    Phase II (Group A): Duration of exposure to each study drug

    Duration of exposure to each study drug will be summarized by means of descriptive statistics

    الإطار الزمني From date of randomization till 30 days safety fup, assessed up to approximately 79 months

  25. مقياس النتيجة الثانوي

    Phase II (Group A): Plasma concentrations of Tulmimetostat and Darolutamide

    In selected number of participants receiving Tulmimetostat and Darolutamide combination therapy in Phase II, or in selected number of participants if only one dose level of Tulmimetostat is evaluated in combination with Darolutamide in Phase II, Tulmimetostat and Darolutamide 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 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  26. مقياس النتيجة الثانوي

    Phase II (Group A): AUC of Tulmimetostat and Darolutamide

    In selected number of participants receiving tulmimetostat and darolutamide combination therapy in Phase II, or in selected number of participants if only one dose level of tulmimetostat is evaluated in combination with darolutamide in Phase II, 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), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics.

    الإطار الزمني Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  27. مقياس النتيجة الثانوي

    Phase II (Group A): Cmax of Tulmimetostat and Darolutamide

    In selected number of participants receiving tulmimetostat and darolutamide combination therapy in Phase II, or in selected number of participants if only one dose level of tulmimetostat is evaluated in combination with darolutamide in Phase II, 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 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  28. مقياس النتيجة الثانوي

    Phase II (Group A): Plasma concentrations of Tulmimetostat

    Tulmimetostat 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 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  29. مقياس النتيجة الثانوي

    Phase II (Group A): AUC of Tulmimetostat

    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), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics.

    الإطار الزمني Cycle 1-2: Day 1 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  30. مقياس النتيجة الثانوي

    Phase II (Group A): Cmax of Tulmimetostat

    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 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days.

  31. مقياس النتيجة الثانوي

    Phase II (Group A): Time to first symptomatic skeletal event (TTSSE)

    Time to first symptomatic skeletal event (TTSSE) is defined as the 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 79 months.

التواريخ

تاريخ البدء13 يناير 2026 (فعلي)
الإتمام الأولي2 أغسطس 2032 (تقديري)
الإتمام2 أغسطس 2032 (تقديري)
أول نشر24 سبتمبر 2025 (فعلي)
آخر تحديث23 يونيو 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيونيو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

30 موقعاً قيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteCamperdownNew South Walesمسحوب
Novartis Investigative SiteWollongongNew South Walesقيد التجنيد

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SitePorto AlegreRio Grande do Sulقيد التجنيد

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteMontrealQuebecقيد التجنيد

China

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteGuangzhouقيد التجنيد

France

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteCréteilقيد التجنيد
Novartis Investigative SiteLilleقيد التجنيد
Novartis Investigative SiteNantesقيد التجنيد

Germany

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteEssenقيد التجنيد
Novartis Investigative SiteJenaThuringiaقيد التجنيد

Hong Kong

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteHong Kongقيد التجنيد

Hungary

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteBudapestقيد التجنيد
Novartis Investigative SiteBudapestقيد التجنيد
Novartis Investigative SiteSzegedقيد التجنيد

Italy

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteRozzanoMIقيد التجنيد
Novartis Investigative SiteVeronaVRقيد التجنيد

South Korea

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteSeoulقيد التجنيد
Novartis Investigative SiteSeoulقيد التجنيد

Spain

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteMadridقيد التجنيد
Novartis Investigative SiteMadridقيد التجنيد
Novartis Investigative SiteMadridقيد التجنيد

Turkey (Türkiye)

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteAnkaraSihhiye-Altindagقيد التجنيد

United Kingdom

المنشأةالمدينةالولاية أو المنطقةالحالة
Novartis Investigative SiteLondonقيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Univ of Alabama at BirminghamBirminghamAlabamaقيد التجنيد
Medical University of South Carolina MUSCCharlestonSouth Carolinaقيد التجنيد
Duke University Medical CenterDurhamNorth Carolinaقيد التجنيد
Uni Of Iowa Hospitals And ClinicsIowa CityIowaقيد التجنيد
Carolina Urologic Research CenterMyrtle BeachSouth Carolinaقيد التجنيد
Huntsman Cancer InstituteSalt Lake CityUtahقيد التجنيد
University of Kansas Cancer CenterWestwoodKansasقيد التجنيد
Wichita Urology Group PAWichitaKansasقيد التجنيد

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07190300