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En studie av ARV-766 gitt gjennom munnen hos menn med metastatisk kastrasjonsresistent prostatakreft som har utviklet seg med tidligere godkjente systemiske terapier

17. august 2026 oppdatert av: Novartis Pharmaceuticals

En fase 1/2 åpen klinisk studie, doseeskalering og kohortutvidelse for å evaluere sikkerheten, tolerabiliteten, farmakokinetikken og farmakodynamikken til ARV-766 hos pasienter med metastatisk kastrasjonsresistent prostatakreft

En fase 1/2-studie for å evaluere sikkerheten og effekten av ARV-766 gitt gjennom munnen hos menn med metastatisk kastrasjonsresistent prostatakreft som har utviklet seg med tidligere godkjente systemiske terapier

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

164

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

14 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

Del A og B:

  • Histologisk, patologisk eller cytologisk bekreftet diagnose av adenokarsinom i prostata.
  • Progressiv mCRPC
  • Pågående androgen deprivasjonsterapi (ADT) med en gonadotropinfrigjørende hormonanalog eller hemmer, eller orkiektomi (kirurgisk eller medisinsk kastrering).
  • Eastern Cooperative Oncology Group (ECOG) ytelsesstatus på 0 eller 1

Del A:

• Progresjon på minst 2 tidligere godkjente systemiske terapier for metastatisk prostatakreft (minst én må være en andregenerasjons androgenhemmer, f.eks. abirateron, enzalutamid, darolutamid, apalutamid).

Del B:

  • Deltakerne må ha mottatt minst én men ikke mer enn tre tidligere andre generasjons anti-androgenmidler (f.eks. enzalutamid eller abirateron).
  • Deltakerne må ikke ha mottatt mer enn to tidligere cellegiftkurer.

Ekskluderingskriterier:

Del A og B:

  • Kjente symptomatiske hjernemetastaser som krever steroider (over fysiologiske erstatningsdoser).
  • Aktiv inflammatorisk gastrointestinal sykdom, kronisk diaré, kjent divertikkelsykdom eller tidligere gastrisk reseksjon eller lapbåndskirurgi.
  • Strålebehandling innen 4 uker etter første dose studiemedisin eller tidligere bestråling til >25 % av benmargen.
  • Mottak av undersøkelseslegemiddel(er) innen 4 uker før forventet første dose
  • Systemisk anti-kreftbehandling innen 2 uker etter første dose av studiemedikamentet (unntatt midler for å opprettholde kastratstatus). For bicalutamid, mitomycin C eller nitrosoureas må eksklusjonsperioden være 6 uker og for abirateron 4 uker.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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 navn:
  • JSB462; luxdegalutamide
Annen: 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 navn:
  • LHRH agonist; LHRH antagonist
Eksperimentell: 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.
Legemiddel: 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 navn:
  • JSB462; luxdegalutamide
Annen: 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 navn:
  • LHRH agonist; LHRH antagonist
Eksperimentell: 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.
Legemiddel: 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 navn:
  • JSB462; luxdegalutamide
Annen: 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 navn:
  • LHRH agonist; LHRH antagonist
Legemiddel: 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 navn:
  • Abirateronacetat
Legemiddel: Corticosteroid (e.g., prednisone/prednisolone)
Prednisone or prednisolone was administered in accordance with local prescribing information during treatment with abiraterone acetate.
Andre navn:
  • Prednisone; Prednisolone

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Etterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. september 2021

Primær fullføring (Antatt)

25. mai 2027

Studiet fullført (Antatt)

25. mai 2027

Datoer for studieregistrering

Først innsendt

23. september 2021

Først innsendt som oppfylte QC-kriteriene

4. oktober 2021

Først lagt ut (Faktiske)

5. oktober 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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