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A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1) (Himalayas-1)

2. September 2026 aktualisiert von: ORIC Pharmaceuticals

A Phase 3, Randomized, Open-Label Study of Rinzimetostat (ORIC-944) in Combination With Darolutamide Compared With ARPI or Docetaxel in Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone Acetate (Himalayas-1)

Himalayas-1 is a randomized, open-label, global, multicenter phase 3 study evaluating whether the combination of rinzimetostat with darolutamide is more effective compared to physician's choice of control; ARPI (darolutamide or enzalutamide) or docetaxel for treating patients with metastatic castration resistant prostate cancer (mCRPC) who were previously treated with abiraterone acetate.

The primary objective of this study is to demonstrate superiority in radiographic progression free survival (rPFS) of the investigational arm of rinzimetostat + darolutamide combination versus physician's choice of control: ARPI (darolutamide or enzalutamide) or docetaxel.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

600

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Indiana
      • Jeffersonville, Indiana, Vereinigte Staaten, 40207
        • Rekrutierung
        • First Urology PSC
    • North Carolina
      • Charlotte, North Carolina, Vereinigte Staaten, 29464
        • Rekrutierung
        • Urology Specialists of the Carolinas - University Place
        • Hauptermittler:
          • Jeremy Hubbard, MD
    • Ohio
      • Canton, Ohio, Vereinigte Staaten, 44718
        • Rekrutierung
        • Gabrail Cancer Center Research
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75231
        • Rekrutierung
        • Urology Clinics of North Texas
      • Fort Worth, Texas, Vereinigte Staaten, 76132
        • Rekrutierung
        • Urology Partners of North Texas (UPNT)
      • Houston, Texas, Vereinigte Staaten, 77027
        • Rekrutierung
        • Houston Metro Urology (HMU)
    • Utah
      • Murray, Utah, Vereinigte Staaten, 84107
        • Rekrutierung
        • Summit Urology
        • Hauptermittler:
          • Stewart Landau, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features
  • Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required
  • Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function

Exclusion Criteria:

  • Prior treatment for prostate cancer at any stage with cytotoxic chemotherapy, radioligand therapy (ie, 177Lu -PSMA-617, radium-223), ARPIs including apalutamide, darolutamide, and enzalutamide, PARP monotherapy or other systemic anticancer treatment (approved drugs or experimental compounds such as, antibody therapy, immunotherapy, gene or cell therapy, angiogenesis inhibitors, CDK4/6 inhibitors, PRC2 inhibitors) with the following exceptions:

    1. Treatment with first-generation antiandrogen agents (eg, bicalutamide, flutamide, nilutamide), but must be discontinued prior to the first dose of study medication
    2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure or disease progression occurred during treatment or within 3 months of treatment completion
  • Any other anticancer therapy (drug or vaccine which does not meet exclusion criterion 1 above) within 28 days or 5 half-lives (whichever is longer) prior to randomization
  • Known or suspected brain metastasis or active leptomeningeal disease
  • Clinically significant cardiovascular disease defined as:
  • Any medical (including active or clinically significant bacterial, fungal, or viral infection) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the patient inappropriate for the study
  • Active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery are excluded

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Investigational Arm
Rinzimetostat + darolutamide
Arzneimittel: Rinzimetostat
400 mg once daily (QD)
Andere Namen:
  • ORIC-944
Arzneimittel: Darolutamide
600 mg twice daily (BID)
Andere Namen:
  • Nubeqa
Aktiver Komparator: Physician's Choice
Control Arm
Arzneimittel: Darolutamide
600 mg twice daily (BID)
Andere Namen:
  • Nubeqa
Arzneimittel: Enzalutamide
160 mg once daily (QD)
Andere Namen:
  • Xtandi
Arzneimittel: Docetaxel
75 mg/m2 intravenously (IV) every 21 days for up to 10 cycles
Andere Namen:
  • Taxotere

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Radiographic Progression Free Survival assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Zeitfenster: Randomization up to ~2 years
Radiographic Progression Free Survival is defined as the time from the date of randomization to first evidence of radiographic progression as assessed in soft tissue by RECIST 1.1 or in bone per PCWG3 guideline by BICR, or death, whichever occurs first
Randomization up to ~2 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS)
Zeitfenster: 5 years
OS is defined as time from date of randomization to date of death due to any cause
5 years
Objective response rate (ORR)
Zeitfenster: Randomization up to ~2 years
ORR is defined as proportion of patients with measurable soft tissue disease at baseline who have a confirmed objective response of complete response (CR) or partial response (PR)
Randomization up to ~2 years
Duration of Response (DoR)
Zeitfenster: Randomization up to ~2 years
DOR is defined as time of first response to first documentation of radiographic progression or death, whichever occurs first
Randomization up to ~2 years
Prostate Specific Antigen (PSA) response
Zeitfenster: Randomization up to ~2 years
Defined as the proportion of patients with a confirmed ≥50% and ≥90% decline in PSA from baseline as per the PCWG3 criteria, along with the maximum decline in PSA occurring at any point on study
Randomization up to ~2 years
Time to PSA progression
Zeitfenster: Randomization up to ~2 years
Measured from the start of treatment until criteria for PSA progression are met as per PCWG3
Randomization up to ~2 years
Time to initiation of antineoplastic therapy
Zeitfenster: Randomization up to ~4 years
Time from randomization to first symptomatic skeletal event (symptomatic bone fractures, spinal cord compression, surgery or radiation to the bone whichever is first)
Randomization up to ~4 years
Time to first symptomatic skeletal event
Zeitfenster: Randomization up to ~4 years
Time from randomization to first symptomatic skeletal event (symptomatic bone fractures, spinal cord compression, surgery or radiation to the bone whichever is first) Compare patient reported outcomes (PROs) between the investigational treatment and control arms
Randomization up to ~4 years
Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)
Zeitfenster: Randomization up to ~4 years
Analysis of Brief Pain Inventory-Short Form (BPI-SF) will be based on the pain severity score (mean of individual BPI-SF items 3, 4, 5 and 6), the pain interference score (the mean of items 9A-9G), and the single BPI-SF Item 3 which asks the patient to rate pain at its worst in the last 24 hours
Randomization up to ~4 years
Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Zeitfenster: Randomization up to ~4 years
Change from baseline in HRQoL (FACT-P total score) will be presented. The FACT-P total score will be calculated based on the participant responses to the 39 items in the FACT-P questionnaire. Each item is rated on a 0 to 4 Likert-type scale and then combined to produce the FACT-P total score (0-156), with higher scores representing better health-related quality of life
Randomization up to ~4 years
Change from baseline in social/family well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Zeitfenster: Randomization up to ~4 years
Change from baseline in social/family well-being score will be presented. The social/family well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale
Randomization up to ~4 years
Change from baseline in functioning well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Zeitfenster: Randomization up to ~4 years
Change from baseline in functioning well-being score will be presented. The functioning well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale
Randomization up to ~4 years
Change from baseline in physical well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Zeitfenster: Randomization up to ~4 years
Change from baseline in physical well-being score will be presented. The physical well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28. Each item is rated on a 0 to 4 Likert-type scale
Randomization up to ~4 years
Change from baseline in symptoms per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Zeitfenster: Randomization up to ~4 years
Change from baseline prostate cancer symptoms (PCS) score will be presented. The PCS score will be calculated based on 12 items in the FACT-P questionnaire; score range 0-48. Each item is rated on a 0 to 4 Likert-type scale
Randomization up to ~4 years
Change from baseline in patient reported health status per European Quality of Life 5-Dimension 5 Level (EQ-5D-5L)
Zeitfenster: Randomization up to ~4 years
Participants will self-rate their current state of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression by choosing 1 of 5 possible responses that record the level of severity (no problems, slight problems, moderate problems, severe problems, or extreme problems) within each dimension. The questionnaire also includes a visual analog scale to self-rate general health state on a scale from "the worst health you can imagine" to "the best health you can imagine."
Randomization up to ~4 years
Symptomatic toxicity as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE)
Zeitfenster: Randomization up to ~2 years
Each selected PRO-CTCAE items will be assessed related to one or more attributes that include counts for the frequency, severity, and/or interference with usual or daily activities
Randomization up to ~2 years
Overall side effect burden as measured by the FACT- GP5
Zeitfenster: Randomization up to ~2 years
The FACT-GP5 question assesses overall side effect burden with the following response options "I am bothered by side effects of treatment," is rated on a 5-point scale ranging from "not at all" (0) to "very much" (4) and counts will be presented
Randomization up to ~2 years
Time to confirmatory deterioration in patient-reported pain symptoms per BPI-SF Item 3 "worst pain in 24 hours"
Zeitfenster: Randomization up to ~4 years
Defined as the time from randomization to onset of pain progression, which is defined as > 2-point increase from baseline in the score from the BPI-SF Question 3 that is confirmed at the next consecutive assessment > 4 weeks apart or an initial deterioration followed by death before the next assessment
Randomization up to ~4 years
Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P
Zeitfenster: Randomization up to ~4 years
Defined as the time from randomization to onset of definitive deterioration in FACT-P total score, which is defined as >10 point decrease from baseline and no subsequent observations with a <10 point decrease from baseline FACT-P total score
Randomization up to ~4 years
Time to definitive deterioration in patient-reported physical well-being per FACT-P
Zeitfenster: Randomization up to ~4 years
Time to definitive deterioration in physical well-being (PWB) per FACT-P is defined as the time from randomization to onset of definitive deterioration in physical well-being, which is defined as ≥3-point
Randomization up to ~4 years
Incidence of Adverse Events (AEs)
Zeitfenster: Randomization up to ~2 years
Type, incidence, relationship to study treatments, severity, and seriousness of AEs [as graded by National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v6.0] and other clinical assessments
Randomization up to ~2 years
Evaluate the pharmacokinetics (PK) of rinzimetostat in combination with darolutamide
Zeitfenster: Randomization up to ~1 year
Rinzimetostat characterized by predose and postdose plasma concentrations at selected time points
Randomization up to ~1 year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

ORIC Pharmaceuticals

Mitarbeiter

Bayer

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

3. August 2026

Primärer Abschluss (Geschätzt)

1. März 2028

Studienabschluss (Geschätzt)

1. September 2030

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Juli 2026

Zuerst gepostet (Tatsächlich)

23. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ORIC-944-05
  • 2026-525340-15-00 (Ctis)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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