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Un estudio de ARV-766 administrado por vía oral en hombres con cáncer de próstata metastásico resistente a la castración que han progresado con terapias sistémicas aprobadas anteriormente

17 de agosto de 2026 actualizado por: Novartis Pharmaceuticals

Un ensayo clínico de Fase 1/2, abierto, de escalada de dosis y expansión de cohortes para evaluar la seguridad, la tolerabilidad, la farmacocinética y la farmacodinámica de ARV-766 en pacientes con cáncer de próstata metastásico resistente a la castración

Un estudio de fase 1/2 para evaluar la seguridad y eficacia de ARV-766 administrado por vía oral en hombres con cáncer de próstata metastásico resistente a la castración que han progresado con terapias sistémicas aprobadas anteriormente

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

The study consists of multiple parts.

  1. Part A evaluates JSB462 monotherapy in a dose-escalation setting to determine safety, tolerability, dose-limiting toxicities, and the maximum tolerated dose or recommended Phase 2 dose (RP2D). Dose escalation follows an accelerated titration design transitioning to a 3+3 design.
  2. Part B is a randomized cohort expansion evaluating JSB462 monotherapy at selected dose levels (e.g., 100 mg or 300 mg once daily) to further assess safety and preliminary antitumor activity at the RP2D. Participants are randomized in a 1:1 ratio.
  3. Part C evaluates JSB462 in combination with abiraterone, administered with corticosteroid and ongoing androgen deprivation therapy. This part assesses safety, tolerability, pharmacokinetics, and defines a recommended dose for the combination regimen. An abiraterone lead-in period is implemented prior to combination treatment.

The study population includes adult males with metastatic prostate cancer. In Parts A and B, participants have metastatic castration-resistant prostate cancer (mCRPC) following prior systemic therapy. Part C includes participants with metastatic prostate cancer, including those who may be naïve to novel hormonal agents.

Primary objectives focus on safety and tolerability, including incidence of adverse events, laboratory abnormalities, and dose-limiting toxicities. In the expansion phase, antitumor activity is evaluated using prostate-specific antigen (PSA) response rates (e.g., PSA30 and PSA50).

Secondary objectives include characterization of pharmacokinetics and further assessment of antitumor activity using endpoints such as objective response rate, radiographic progression-free survival, duration of response, and time to PSA progression. Tumor assessments are performed using modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 for soft tissue disease and Prostate Cancer Working Group 3 (PCWG3) criteria for bone disease, with imaging conducted at regular intervals.

This study aims to characterize the clinical profile of JSB462 and explore its potential to overcome resistance mechanisms associated with androgen receptor signaling in metastatic prostate cancer.

Tipo de estudio

Intervencionista

Inscripción (Actual)

164

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Duarte, California, Estados Unidos, 91010
        • City of Hope National Medical
      • La Jolla, California, Estados Unidos, 92093-0658
        • University of California San Diego - Moores Cancer Center
      • Santa Monica, California, Estados Unidos, 90404
        • Providence Saint Johns Health Ctr
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06520
        • Yale Cancer Center
    • Florida
      • Fort Myers, Florida, Estados Unidos, 33901
        • Florida Cancer Specialists
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21204
        • Chesapeake Urology Associates
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Karmanos Cancer Institute
    • New York
      • Buffalo, New York, Estados Unidos, 14203
        • Roswell Park Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232
        • Univ of Pittsburgh Cancer Inst
    • South Carolina
      • Myrtle Beach, South Carolina, Estados Unidos, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • SCRI Oncology Partners
    • Texas
      • San Antonio, Texas, Estados Unidos, 78229
        • Urology San Antonio
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
        • University of Virginia Medical Center
      • Fairfax, Virginia, Estados Unidos, 22031
        • Virginia Cancer Specialists
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792-6164
        • University of Wisconsin Paul P Carbone Comp Cancer Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

14 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

Parte A y B:

  • Diagnóstico histológico, patológico o citológico confirmado de adenocarcinoma de próstata.
  • CPRCm progresivo
  • Terapia continua de privación de andrógenos (ADT) con un análogo o inhibidor de la hormona liberadora de gonadotropina, u orquiectomía (castración quirúrgica o médica).
  • Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 o 1

Parte A:

• Progresión en al menos 2 tratamientos sistémicos aprobados anteriormente para el cáncer de próstata metastásico (al menos uno debe ser un inhibidor de andrógenos de segunda generación, por ejemplo, abiraterona, enzalutamida, darolutamida, apalutamida).

Parte B:

  • Los participantes deben haber recibido al menos uno pero no más de tres agentes antiandrógenos de segunda generación (p. ej., enzalutamida o abiraterona).
  • Los participantes no deben haber recibido más de dos regímenes de quimioterapia anteriores.

Criterio de exclusión:

Parte A y B:

  • Metástasis cerebrales sintomáticas conocidas que requieren esteroides (por encima de las dosis de reemplazo fisiológico).
  • Enfermedad gastrointestinal inflamatoria activa, diarrea crónica, enfermedad diverticular conocida o resección gástrica previa o cirugía de banda gástrica.
  • Radioterapia dentro de las 4 semanas posteriores a la primera dosis del fármaco del estudio o irradiación previa a >25 % de la médula ósea.
  • Recepción de un fármaco en investigación dentro de las 4 semanas anteriores a la primera dosis anticipada
  • Terapia sistémica contra el cáncer dentro de las 2 semanas posteriores a la primera dosis del fármaco del estudio (excepto agentes para mantener el estado de castración). Para bicalutamida, mitomicina C o nitrosoureas el período de exclusión debe ser de 6 semanas y para abiraterona de 4 semanas.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Part A: ARV-766 Monotherapy (Dose Escalation)
Participants with metastatic prostate cancer received escalating dose levels of ARV-766 administered orally to evaluate safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose and/or recommended Phase 2 dose. Participants continued androgen deprivation therapy as clinically indicated.
Droga: ARV-766

Parts A and C: Daily oral dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment.

Part B: 100mg or 300mg oral tablet(s) once daily in 28 day cycles.

Otros nombres:
  • JSB462; luxdegalutamide
Otro: Androgen Deprivation Therapy (ADT)
Ongoing androgen deprivation therapy, including luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or prior orchiectomy, is maintained per investigator choice or patient preference.
Otros nombres:
  • LHRH agonist; LHRH antagonist
Experimental: Part B: ARV-766 Monotherapy (Dose Expansion)
Participants with metastatic castration-resistant prostate cancer received ARV-766 administered orally at selected dose levels to further evaluate antitumor activity, safety, tolerability, and pharmacokinetics. Participants continued androgen deprivation therapy as clinically indicated.
Droga: ARV-766

Parts A and C: Daily oral dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment.

Part B: 100mg or 300mg oral tablet(s) once daily in 28 day cycles.

Otros nombres:
  • JSB462; luxdegalutamide
Otro: Androgen Deprivation Therapy (ADT)
Ongoing androgen deprivation therapy, including luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or prior orchiectomy, is maintained per investigator choice or patient preference.
Otros nombres:
  • LHRH agonist; LHRH antagonist
Experimental: Part C: ARV-766 + Abiraterone
Participants received ARV-766 in combination with abiraterone acetate and a corticosteroid (prednisone or prednisolone) to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of the combination regimen. Participants continued androgen deprivation therapy as clinically indicated.
Droga: ARV-766

Parts A and C: Daily oral dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment.

Part B: 100mg or 300mg oral tablet(s) once daily in 28 day cycles.

Otros nombres:
  • JSB462; luxdegalutamide
Otro: Androgen Deprivation Therapy (ADT)
Ongoing androgen deprivation therapy, including luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or prior orchiectomy, is maintained per investigator choice or patient preference.
Otros nombres:
  • LHRH agonist; LHRH antagonist
Droga: Abiraterone
Abiraterone is administered orally in combination with ARV-766, typically on an empty stomach with water, in accordance with prescribing information and standard clinical practice.
Otros nombres:
  • Acetato de abiraterona
Droga: Corticosteroid (e.g., prednisone/prednisolone)
Prednisone or prednisolone was administered in accordance with local prescribing information during treatment with abiraterone acetate.
Otros nombres:
  • Prednisone; Prednisolone

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part A: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment
Periodo de tiempo: Up to 28 days
Number and proportion of participants experiencing dose-limiting toxicities during the DLT evaluation period to assess safety and determine the maximum tolerated dose (MTD) of ARV-766 and/or recommended Phase 2 dose (RP2D)
Up to 28 days
Part C: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment
Periodo de tiempo: Up to 28 Days
Number and proportion of participants experiencing dose-limiting toxicities during the DLT evaluation period to determine the recommended dose of ARV-766 in combination with abiraterone
Up to 28 Days
Parts A and C: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: From first dose through approximately 30 days after last dose
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
From first dose through approximately 30 days after last dose
Parts A and C: Incidence of laboratory abnormalities
Periodo de tiempo: From first dose through approximately 30 days after last dose
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.
From first dose through approximately 30 days after last dose
Part B: Prostate-Specific Antigen 30% Response Rate (PSA30)
Periodo de tiempo: 12 Weeks
Prostate Specific Antigen 30 (PSA30) Rate is defined as the proportion of participants who achieve a ≥30% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between
12 Weeks
Part B: Prostate-Specific Antigen 50% Response Rate (PSA50)
Periodo de tiempo: 12 Weeks
Prostate Specific Antigen 50 (PSA50) Rate is defined as the proportion of participants who achieve a ≥50% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between
12 Weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part A: Prostate-Specific Antigen 30% Response Rate (PSA30)
Periodo de tiempo: 12 Weeks
Prostate Specific Antigen 30 (PSA30) Rate is defined as the proportion of participants who achieve a ≥30% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between
12 Weeks
Part A: Prostate-Specific Antigen 50% Response Rate (PSA50)
Periodo de tiempo: 12 Weeks
Prostate Specific Antigen 50 (PSA50) Rate is defined as the proportion of participants who achieve a ≥50% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between
12 Weeks
Part A: Objective Response Rate (ORR)
Periodo de tiempo: 12 Weeks
Overall Response Rate (ORR) is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) per PCWG3-modified RECIST 1.1 as assessed by the investigator
12 Weeks
Parts A and B: Radiographic Progression-Free Survival (rPFS)
Periodo de tiempo: Baseline to radiographic progression or death, whichever occurs first, assessed up to 68 months
Time from first dose to radiographic disease progression per modified RECIST Version 1.1 for soft tissue lesions and PCWG3 criteria for bone lesions, or death from any cause.
Baseline to radiographic progression or death, whichever occurs first, assessed up to 68 months
Parts A and B: Duration of Response (DoR)
Periodo de tiempo: From first documented response to disease progression or death, whichever occurs first, assessed up to 68 months
Duration of Response (DOR) is defined as the 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
From first documented response to disease progression or death, whichever occurs first, assessed up to 68 months
Parts A and B: Time to Prostate-Specific Antigen Progression
Periodo de tiempo: Baseline to prostate-specific antigen progression, assessed up to 68 months
Time to PSA progression is the time interval from the date of first study drug dose to the date of PSA progression. The PSA progression date is defined as the date that a ≥25% increase and an absolute increase of ≥2 ng/mL above the nadir is documented, which is confirmed by a second consecutive value obtained 3 or more weeks later
Baseline to prostate-specific antigen progression, assessed up to 68 months
Part A: Area Under the plasma Concentration-Time Curve (AUC) of ARV-766
Periodo de tiempo: Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast), Area under the plasma concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the plasma concentration-time curve from time zero during a dosing interval (AUCtau) will be listed and summarized using descriptive statistics.
Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part A: Maximum Observed Concentration (Cmax) of ARV-766
Periodo de tiempo: Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. Cmax will be listed and summarized using descriptive statistics.
Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part A: Time to Maximum Concentration (Tmax) of ARV-766
Periodo de tiempo: Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. Tmax will be listed and summarized using descriptive statistics.
Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part A: Last Measurable Concentration (Clast) of ARV-766
Periodo de tiempo: Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. Clast will be listed and summarized using descriptive statistics.
Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part A: Minimum Observed Concentration (Cmin) of ARV-766
Periodo de tiempo: Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. Cmin will be listed and summarized using descriptive statistics.
Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part A: Apparent total body clearance (CL/F) of ARV-766
Periodo de tiempo: Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. CL/F will be listed and summarized using descriptive statistics.
Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part A: Apparent Volume of Distribution (Vd/F) of ARV-766
Periodo de tiempo: Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. Vd/F will be listed and summarized using descriptive statistics.
Cycle 1: Days 1 & 21 (0, 1, 2, 3, 4, 6, 8 and 12 hours), Day 2 (0 hour). Cycle 2 and beyond (0 hour). End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part B: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: From first dose through approximately 30 days after last dose
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
From first dose through approximately 30 days after last dose
Part B: Incidence of laboratory abnormalities
Periodo de tiempo: From first dose through approximately 30 days after last dose
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.
From first dose through approximately 30 days after last dose
Part C: Area Under the plasma Concentration-Time Curve (AUC) of Abiraterone/ARV-766
Periodo de tiempo: Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for Abiraterone/ARV-766 characterization. Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast), Area under the plasma concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the plasma concentration-time curve from time zero during a dosing interval (AUCtau) will be listed and summarized using descriptive statistics.
Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part C: Maximum Observed Concentration (Cmax) of ARV-766
Periodo de tiempo: Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. Cmax will be listed and summarized using descriptive statistics.
Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part C: Time to Maximum Concentration (Tmax) of ARV-766
Periodo de tiempo: Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. Tmax will be listed and summarized using descriptive statistics.
Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part C: Last Measurable Concentration (Clast) of ARV-766
Periodo de tiempo: Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. Clast will be listed and summarized using descriptive statistics.
Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part C: Minimum Observed Concentration (Cmin) of ARV-766
Periodo de tiempo: Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. Cmin will be listed and summarized using descriptive statistics.
Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part C: Apparent total body clearance (CL/F) of ARV-766
Periodo de tiempo: Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. CL/F will be listed and summarized using descriptive statistics.
Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Part C: Apparent Volume of Distribution (Vd/F) of ARV-766
Periodo de tiempo: Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.
Venous whole blood samples will be collected for ARV-766 characterization. Vd/F will be listed and summarized using descriptive statistics.
Cycle 1 Days -8, -1, 1, 21, and 28; Cycle 2 Day 28; and Cycle ≥3 Day 28 (odd cycles only), with intensive post-dose PK on Days -1, 1, and 21; End of Treatment Visit (EOT): within 4 weeks from the last dose of ARV-766. 1 cycle = 28 days.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Investigadores

  • Director de estudio: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de septiembre de 2021

Finalización primaria (Estimado)

25 de mayo de 2027

Finalización del estudio (Estimado)

25 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

23 de septiembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

4 de octubre de 2021

Publicado por primera vez (Actual)

5 de octubre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CJSB462A12101
  • ARV-766-mCRPC-101 (Otro identificador: Arvinas Inc.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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