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En undersøgelse af ARV-766 givet gennem munden hos mænd med metastatisk kastrationsresistent prostatacancer, som har udviklet sig med tidligere godkendte systemiske terapier

17. august 2026 opdateret af: Novartis Pharmaceuticals

Et fase 1/2 åbent klinisk forsøg, dosiseskalering og kohorteudvidelse til evaluering af sikkerheden, tolerabiliteten, farmakokinetikken og farmakodynamikken af ​​ARV-766 hos patienter med metastatisk kastrationsresistent prostatacancer

Et fase 1/2-studie for at evaluere sikkerheden og effektiviteten af ​​ARV-766 givet gennem munden hos mænd med metastatisk kastrationsresistent prostatacancer, som har udviklet sig med tidligere godkendte systemiske behandlinger

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

164

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

Del A og B:

  • Histologisk, patologisk eller cytologisk bekræftet diagnose af adenocarcinom i prostata.
  • Progressiv mCRPC
  • Igangværende androgen deprivationsterapi (ADT) med en gonadotropinfrigivende hormonanalog eller inhibitor, eller orkiektomi (kirurgisk eller medicinsk kastration).
  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus på 0 eller 1

Del A:

• Progression på mindst 2 tidligere godkendte systemiske behandlinger for metastatisk prostatacancer (mindst én skal være en andengenerations androgenhæmmer, f.eks. abirateron, enzalutamid, darolutamid, apalutamid).

Del B:

  • Deltagerne skal have modtaget mindst én men ikke mere end tre tidligere anden generations anti-androgenmidler (f.eks. enzalutamid eller abirateron).
  • Deltagerne må ikke have modtaget mere end to tidligere kemoterapiregimer.

Ekskluderingskriterier:

Del A og B:

  • Kendte symptomatiske hjernemetastaser, der kræver steroider (over fysiologiske erstatningsdoser).
  • Aktiv inflammatorisk gastrointestinal sygdom, kronisk diarré, kendt divertikulær sygdom eller tidligere gastrisk resektion eller lapbåndsoperation.
  • Strålebehandling inden for 4 uger efter første dosis af forsøgslægemidlet eller forudgående bestråling til >25 % af knoglemarven.
  • Modtagelse af et eller flere forsøgslægemidler inden for 4 uger før forventet første dosis
  • Systemisk anti-cancerbehandling inden for 2 uger efter første dosis af undersøgelseslægemidlet (undtagen midler til at opretholde kastratstatus). For bicalutamid, mitomycin C eller nitrosoureas skal udelukkelsesperioden være 6 uger og for abirateron 4 uger.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.

Andre navne:
  • JSB462; luxdegalutamide
Andet: 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.
Andre navne:
  • LHRH agonist; LHRH antagonist
Eksperimentel: 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.
Medicin: 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.

Andre navne:
  • JSB462; luxdegalutamide
Andet: 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.
Andre navne:
  • LHRH agonist; LHRH antagonist
Eksperimentel: 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.
Medicin: 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.

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part A: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part A: Prostate-Specific Antigen 30% Response Rate (PSA30)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. september 2021

Primær færdiggørelse (Anslået)

25. maj 2027

Studieafslutning (Anslået)

25. maj 2027

Datoer for studieregistrering

Først indsendt

23. september 2021

Først indsendt, der opfyldte QC-kriterier

4. oktober 2021

Først opslået (Faktiske)

5. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CJSB462A12101
  • ARV-766-mCRPC-101 (Anden identifikator: Arvinas Inc.)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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