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Eine Studie über oral verabreichtes ARV-766 bei Männern mit metastasiertem, kastrationsresistentem Prostatakrebs, die unter zuvor zugelassenen systemischen Therapien Fortschritte gemacht haben

17. August 2026 aktualisiert von: Novartis Pharmaceuticals

Eine offene klinische Phase-1/2-Studie mit Dosiseskalation und Kohortenerweiterung zur Bewertung der Sicherheit, Verträglichkeit, Pharmakokinetik und Pharmakodynamik von ARV-766 bei Patienten mit metastasiertem, kastrationsresistentem Prostatakrebs

Eine Phase-1/2-Studie zur Bewertung der Sicherheit und Wirksamkeit von oral verabreichtem ARV-766 bei Männern mit metastasiertem, kastrationsresistentem Prostatakrebs, die unter zuvor zugelassenen systemischen Therapien Fortschritte gemacht haben

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

164

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

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

Studienorte

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

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

14 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

Teil A und B:

  • Histologische, pathologische oder zytologische gesicherte Diagnose eines Adenokarzinoms der Prostata.
  • Progressives mCRPC
  • Laufende Androgendeprivationstherapie (ADT) mit einem Gonadotropin-Releasing-Hormon-Analogon oder -Inhibitor oder Orchiektomie (chirurgische oder medizinische Kastration).
  • Leistungsstatus der Eastern Cooperative Oncology Group (ECOG) von 0 oder 1

Teil A:

• Fortschritt unter mindestens 2 zuvor zugelassenen systemischen Therapien für metastasierten Prostatakrebs (mindestens eine muss ein Androgeninhibitor der zweiten Generation sein, z. B. Abirateron, Enzalutamid, Darolutamid, Apalutamid).

Teil B:

  • Die Teilnehmer müssen mindestens ein, aber nicht mehr als drei Antiandrogenmittel der zweiten Generation (z. B. Enzalutamid oder Abirateron) erhalten haben.
  • Die Teilnehmer dürfen nicht mehr als zwei vorangegangene Chemotherapien erhalten haben.

Ausschlusskriterien:

Teil A und B:

  • Bekannte symptomatische Hirnmetastasen, die Steroide erfordern (über physiologischen Ersatzdosen).
  • Aktive entzündliche Magen-Darm-Erkrankung, chronischer Durchfall, bekannte Divertikulose oder frühere Magenresektion oder Lap-Band-Operation.
  • Strahlentherapie innerhalb von 4 Wochen nach der ersten Dosis des Studienmedikaments oder vorherige Bestrahlung von > 25 % des Knochenmarks.
  • Erhalt eines oder mehrerer Prüfpräparate innerhalb von 4 Wochen vor der erwarteten ersten Dosis
  • Systemische Krebstherapie innerhalb von 2 Wochen nach der ersten Dosis des Studienmedikaments (ausgenommen Mittel zur Aufrechterhaltung des Kastratenstatus). Für Bicalutamid, Mitomycin C oder Nitrosoharnstoffe muss die Ausschlussfrist 6 Wochen und für Abirateron 4 Wochen betragen.

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: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: 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.

Andere Namen:
  • JSB462; luxdegalutamide
Sonstiges: 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.
Andere Namen:
  • 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.
Arzneimittel: 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.

Andere Namen:
  • JSB462; luxdegalutamide
Sonstiges: 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.
Andere Namen:
  • 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.
Arzneimittel: 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.

Andere Namen:
  • JSB462; luxdegalutamide
Sonstiges: 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.
Andere Namen:
  • LHRH agonist; LHRH antagonist
Arzneimittel: 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.
Andere Namen:
  • Abirateronacetat
Arzneimittel: Corticosteroid (e.g., prednisone/prednisolone)
Prednisone or prednisolone was administered in accordance with local prescribing information during treatment with abiraterone acetate.
Andere Namen:
  • Prednisone; Prednisolone

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part A: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part A: Prostate-Specific Antigen 30% Response Rate (PSA30)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

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

Sponsor

Novartis Pharmaceuticals

Ermittler

  • Studienleiter: Novartis Pharmaceuticals, Novartis Pharmaceuticals

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)

2. September 2021

Primärer Abschluss (Geschätzt)

25. Mai 2027

Studienabschluss (Geschätzt)

25. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

23. September 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Oktober 2021

Zuerst gepostet (Tatsächlich)

5. Oktober 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. August 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CJSB462A12101
  • ARV-766-mCRPC-101 (Andere Kennung: Arvinas Inc.)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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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