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Sikkerhed og effektivitet af terapier til metastatisk kastrationsresistent prostatacancer (mCRPC)

4. august 2026 opdateret af: Amgen

En masterprotokol, der evaluerer sikkerheden og effektiviteten af ​​terapier til metastatisk kastrationsresistent prostatacancer (mCRPC)

Dette er en masterprotokol designet til at evaluere sikkerheden og effektiviteten af ​​undersøgelsesterapier hos deltagere med metastatisk kastrationsresistent prostatacancer (mCRPC).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er en masterprotokol designet til at evaluere sikkerhed, tolerabilitet og maksimal tolereret dosis (MTD) eller anbefalet fase 2-dosis (RP2D) og effektivitet af Acapatamab i kombination med enzalutamid, abirateron eller PD1-hæmmeren AMG 404, AMG 404 monoterapi , samt Acapatamab monoterapi, hos deltagere med metastatisk kastrationsresistent prostatacancer (mCRPC).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

55

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

  • Australien
    • New South Wales
      • Darlinghurst, New South Wales, Australien, 2010
        • St Vincents Hospital Sydney
  • Danmark
      • København Ø, Danmark, 2100
        • Rigshospitalet
  • Det Forenede Kongerige
      • Sutton, Det Forenede Kongerige, SM2 5PT
        • Royal Marsden Hospital
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • California
      • Orange, California, Forenede Stater, 92868
        • University of California at Irvine Medical Center
      • San Francisco, California, Forenede Stater, 94158
        • University of California San Francisco Mission Bay Campus
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40207
        • Norton Cancer Institute
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas MD Anderson Cancer Center
  • Spanien
    • Navarre
      • Pamplona, Navarre, Spanien, 31008
        • Clinica Universidad de Navarra
  • Sverige
      • Lund, Sverige, 221 85
        • Skånes universitetssjukhus
      • Stockholm, Sverige, 171 76
        • Karolinska Universitetssjukhuset Solna
      • Uppsala, Sverige, 75185
        • Akademiska Sjukhuset

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

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Alle dele

Inklusionskriterier:

  • ≥ 18 år (eller lovlig voksen alder i landet)
  • Forsøgspersonen har givet informeret samtykke forud for påbegyndelse af undersøgelsesspecifikke aktiviteter/procedurer
  • Forsøgspersoner med mCRPC med histologisk eller cytologisk bekræftet adenocarcinom i prostata
  • Forsøgspersoner bør have gennemgået bilateral orkiektomi eller bør være i kontinuerlig androgen-deprivationsterapi med en gonadotropinfrigørende hormonagonist eller -antagonist (testosteron ≤ 50 ng/dL (eller 1,7 nmol/L))

Ekskluderingskriterier:

  • Metastaser i centralnervesystemet (CNS) eller leptomeningeal sygdom
  • Anamnese eller tilstedeværelse af klinisk relevant CNS-patologi
  • Bekræftet historie eller aktuel autoimmun sygdom eller andre sygdomme, der kræver permanent immunsuppressiv behandling
  • Myokardieinfarkt, ukontrolleret hypertension, ustabil angina, hjertearytmi, der kræver medicin og/eller symptomatisk kongestiv hjerteinsufficiens (New York Heart Association > klasse II) inden for 12 måneder
  • Forudgående behandling med en taxan til mCRPC
  • Større operation og/eller stråling inden for 4 uger

  • Anamnese eller tegn på alvorlig akut respiratorisk syndrom coronavirus 2 (SARS-CoV-2) infektion, medmindre det er aftalt med medicinsk monitor og opfylder følgende kriterier:

    • Negativ test for SARS-CoV-2 RNA ved realtids polymerasekædereaktion (RT-PCR) inden for 72 timer efter første dosis af Acapatamab (eller AMG 404 i del 3)
    • Ingen akutte symptomer på COVID-19 sygdom inden for 10 dage før første dosis af Acapatamab (eller AMG 404 i del 3) (talt fra dagen for positiv test for asymptomatiske forsøgspersoner)

Tidligere/samtidig klinisk undersøgelseserfaring

  • Modtager i øjeblikket behandling i en anden afprøvningsanordning eller lægemiddelundersøgelse, eller mindre end 4 uger efter endt behandling med en anden afprøvningsanordning eller lægemiddelundersøgelse(r). Andre undersøgelsesprocedurer under deltagelse i denne undersøgelse er udelukket med undtagelse af undersøgelsesscanninger.

Kun underprotokol A:

Inklusionskriterier

• Forsøgspersoner, der planlægger at modtage enzalutamid for første gang for mCRPC

Eksklusionskriterier

  • Brug af stærke CYP2C8-hæmmere eller stærke CYP3A4-inducere
  • Brug af lægemidler med smalt terapeutisk indeks, der er substrater for CYP3A4, CYP2C9 eller CYP2C19

Kun underprotokol B:

Inklusionskriterier

  • Forsøgspersoner, der planlægger at modtage abirateron for første gang for mCRPC-eksklusionskriterier
  • Baseline moderat og svær leverinsufficiens (Child-Pugh klasse B og C)
  • Tilstedeværelse af ukontrolleret hypertension, hypokaliæmi eller væskeretention
  • Anamnese eller tilstedeværelse af binyrebarkinsufficiens
  • Brug af samtidig medicin, der er følsomme substrater for CYP2D6 med et snævert terapeutisk indeks
  • Brug af stærke CYP3A4-inducere

Kun underprotokol C:

Inklusionskriterier

  • Personer, der er refraktære over for en ny antiandrogen terapi. Forsøgspersoner skal være ude af stand til eller nægte taxanbehandling.
  • Bevis for progressiv sygdom, defineret som 1 eller flere PCWG3-kriterier: PSA-niveau >/=1 ng/ml, der er steget ved mindst 2 på hinanden følgende lejligheder med mindst 1 uges mellemrum, nodal eller visceral progression som defineret af RECIST 1.1 med PCGW3-modifikationer, og/eller forekomst af 2 eller flere nye læsioner i knoglescanning Eksklusionskriterier
  • Anamnese eller tegn på interstitiel lungesygdom eller aktiv, ikke-infektiøs pneumonitis
  • Forsøgspersoner på en tidligere PD-1- eller PD-L1-hæmmer, som oplevede en grad 3 eller højere immunrelateret bivirkning før første dosisdag

Kun underprotokol D:

Inklusionskriterier

  • Forsøgspersoner kan have haft nye hormonbehandlinger (NHT; f.eks. abirateron, enzalutamid, apalutamid eller darolutamid) for prostatacancer, men ikke mere end 1 NHT for metastatisk prostatacancer
  • Ikke berettiget til eller afslå taxanbehandling

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: Acapatamab og Enzalutamid: Dosisundersøgelse
Dosisudforskningsdelen af ​​studiet vil estimere MTD/anbefalet fase 2-dosis (RP2D) af Acapatamab i kombination med enzalutamid.
Medicin: Acapatamab
Acapatamab vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PSMA målrettet terapi
Medicin: Enzalutamid
Enzalutamid vil blive indgivet oralt.
Andre navne:
  • Androgen receptor hæmmer
Eksperimentel: Acapatamab og Enzalutamid: Dosisudvidelse
Efter dosisudforskning vil dosisudvidelse blive udført for at bekræfte sikkerheden og tolerabiliteten af ​​den valgte dosis og for yderligere at evaluere effekten af ​​Acapatamab i kombination med enzalutamid.
Medicin: Acapatamab
Acapatamab vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PSMA målrettet terapi
Medicin: Enzalutamid
Enzalutamid vil blive indgivet oralt.
Andre navne:
  • Androgen receptor hæmmer
Eksperimentel: Acapatamab og Abiraterone: Dosisundersøgelse
Dosisudforskningsdelen af ​​studiet vil estimere MTD/anbefalet fase 2-dosis (RP2D) af Acapatamab i kombination med abirateron.
Medicin: Acapatamab
Acapatamab vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PSMA målrettet terapi
Medicin: Abiraterone
Abirateron vil blive indgivet oralt.
Andre navne:
  • Cytokrom P450 (CYP)17 hæmmer
Eksperimentel: Acapatamab og Abirateron: Dosisudvidelse
Efter dosisudforskning vil dosisudvidelse blive udført for at bekræfte sikkerheden og tolerabiliteten af ​​den valgte dosis og for yderligere at evaluere effekten af ​​Acapatamab i kombination med abirateron.
Medicin: Acapatamab
Acapatamab vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PSMA målrettet terapi
Medicin: Abiraterone
Abirateron vil blive indgivet oralt.
Andre navne:
  • Cytokrom P450 (CYP)17 hæmmer
Eksperimentel: Acapatamab og AMG 404: Dosisundersøgelse
Dosisudforskningsdelen af ​​studiet vil estimere MTD/RP2D for Acapatamab i kombination med AMG 404.
Medicin: Acapatamab
Acapatamab vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PSMA målrettet terapi
Medicin: AMG 404
AMG 404 vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PD-1 hæmmer
Eksperimentel: Acapatamab og AMG 404: Dosisudvidelse
Efter dosisudforskning vil dosisudvidelse blive udført for at bekræfte sikkerheden og tolerabiliteten af ​​den valgte dosis og for yderligere at evaluere effekten af ​​Acapatamab i kombination med AMG 404.
Medicin: Acapatamab
Acapatamab vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PSMA målrettet terapi
Medicin: AMG 404
AMG 404 vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PD-1 hæmmer
Aktiv komparator: AMG 404 Monoterapi
AMG 404 monoterapi udføres for at evaluere den foreløbige antitumoraktivitet af PD-1-hæmning i mCRPC-populationen.
Medicin: AMG 404
AMG 404 vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PD-1 hæmmer
Eksperimentel: Acapatamab og Enzalutamid: Dosisudvidelse Asien-kohorte
Efter dosisudforskning vil dosisudvidelsen blive udført i Asien-kohorten ved kombinationen MTD/RP2D bestemt i dosisudforskning for at bekræfte sikkerheden, tolerabiliteten og PK af Acapatamab i kombination med enzalutamid til forsøgspersoner i Asien.
Medicin: Acapatamab
Acapatamab vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PSMA målrettet terapi
Medicin: Enzalutamid
Enzalutamid vil blive indgivet oralt.
Andre navne:
  • Androgen receptor hæmmer
Eksperimentel: Acapatamab og Abiraterone: Dosisudvidelse Asien-kohorte
Efter dosisudforskning vil dosisudvidelse blive udført i Asien-kohorten ved kombinationen MTD/RP2D bestemt i dosisudforskning for at bekræfte sikkerheden, tolerabiliteten og PK af Acapatamab i kombination med abirateron for forsøgspersoner i Asien.
Medicin: Acapatamab
Acapatamab vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PSMA målrettet terapi
Medicin: Abiraterone
Abirateron vil blive indgivet oralt.
Andre navne:
  • Cytokrom P450 (CYP)17 hæmmer
Eksperimentel: Acapatamab og AMG 404: Dosisudvidelse Asien-kohorte
Efter dosisudforskning vil dosisudvidelse blive udført i Asien-kohorten ved kombinationen MTD/RP2D bestemt i dosisudforskning for at bekræfte sikkerheden, tolerabiliteten og PK af Acapatamab i kombination med AMG 404 for forsøgspersoner i Asien.
Medicin: Acapatamab
Acapatamab vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PSMA målrettet terapi
Medicin: AMG 404
AMG 404 vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PD-1 hæmmer
Eksperimentel: Acapatamab monoterapi
Acapatamab monoterapi udføres for at evaluere sikkerhed, tolerabilitet, farmakokinetik (PK), farmakodynamik og effekt af Acapatamab hos personer med mCRPC.
Medicin: Acapatamab
Acapatamab vil blive administreret som en intravenøs (IV) infusion.
Andre navne:
  • PSMA målrettet terapi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Tidsramme: Cycle 1: Day 1 to Day 28 (28-day cycle)

DLTs were defined as any adverse event (AE) (per Common Terminology Criteria for Adverse Events (CTCAE) v5: Grade 5=Death, Grade 4=Life-threatening, Grade 3=Moderate) occurring within 28 days of the first AMG 160 dose, possibly related to the treatment, including:

  • Grade 5 toxicity
  • Grade 4 thrombocytopenia
  • Grade 3 thrombocytopenia with significant hemorrhage
  • Grade 4 neutropenia > 5 days
  • Febrile neutropenia
  • Grade 3 anemia requiring transfusion
  • Grade ≥3 non-hematologic toxicity (with exceptions per protocol)
  • Aspartate transaminase/alanine transaminase >3x upper limit of normal (ULN) with serum total bilirubin >2x ULN without cholestasis or another clear cause
  • Grade ≥3 non-hematological toxicity delaying treatment > 2 weeks or resulting in <75% dose administration.

The complete list of DLTs are described in the protocol
Cycle 1: Day 1 to Day 28 (28-day cycle)
Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs
Tidsramme: From first dose of acapatamab/AMG 404 to the first of 30 days after last dose of acapatamab/AMG404, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 4.665 (0.33, 25.17) months

A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started on or after first dose of investigational product (AMG 160 or AMG 404 for Part 1 and 2; AMG 404 for Part 3).

A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab, or AMG 404 (subprotocol C, parts 1 and 2 only).

Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs.
From first dose of acapatamab/AMG 404 to the first of 30 days after last dose of acapatamab/AMG404, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 4.665 (0.33, 25.17) months
Subprotocol D: Number of Participants Who Experienced TEAEs and Treatment-related AEs
Tidsramme: From first dose of acapatamab to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy, whichever is earlier; median (min, max) duration was 4.665 (0.33, 25.17) months

A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started after the first dose of acapatamab.

A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab.

Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs.
From first dose of acapatamab to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy, whichever is earlier; median (min, max) duration was 4.665 (0.33, 25.17) months
Subprotocol C, Part 3: Objective Response Rate (ORR)
Tidsramme: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or end of trial median (min, max) duration was 6.14 (0.14, 105.14) weeks
Objective Response is defined as a complete response (CR) or partial response (PR) per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later. Participants who did not experience a confirmed CR or PR, or did not have any follow-up tumor assessments were regarded as non-responders.
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or end of trial median (min, max) duration was 6.14 (0.14, 105.14) weeks
Subprotocol C, Part 3: Percentage of Participants Who Experienced a Circulating Tumor Cell 0 (CTC0) Response
Tidsramme: Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
CTC0 response was defined as CTC0 (reduction of CTCs > 0 to 0 at any post-baseline measurement). The baseline was defined as the last non-missing value on or prior to the pre-dose of AMG 404 assessments on Cycle 1 Day 1.
Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
Subprotocol C, Part 3: Percentage of Participants Who Experienced a CTC Conversion Response
Tidsramme: Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
CTC conversion response was defined as ≥ 5 CTCs/7.5 mL blood at baseline that converted to ≤ 4 CTCs/7.5 mL blood at any post-baseline measurement. The baseline was defined as the last non-missing value on or prior to the pre-dose assessments of AMG 404 on Cycle 1 Day 1.
Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
Subprotocol C, Part 3: Percentage of Participants Who Experienced a Prostate Specific Antigen (PSA) Response
Tidsramme: Cycle 1 Day 1 to 5 months post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)

A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:

  • PSA 30 response: ≥ 30% reduction from the baseline PSA.
  • PSA 50 response: ≥ 50% reduction from the baseline PSA.
  • PSA 70 response: ≥ 70% reduction from the baseline PSA.
  • PSA 90 response: ≥ 90% reduction from the baseline PSA.

The baseline was defined as the last non-missing value on or prior to the pre-dose of AMG 404 assessments on Cycle 1 Day 1.
Cycle 1 Day 1 to 5 months post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subprotocols A. B, C (Parts 1 and 2) and D: ORR
Tidsramme: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Objective Response is defined as a CR or PR per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later. Participants who did not experience a confirmed CR or PR, or did not have any follow-up tumor assessments were regarded as non-responders.
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC0 Response
Tidsramme: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
CTC0 response was defined as CTC0 (reduction of CTCs > 0 to 0 at any post-baseline measurement). The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1 > 0.
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC Conversion Response
Tidsramme: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
CTC conversion response was defined as ≥ 5 CTCs/7.5 mL blood at baseline that converted to ≤ 4 CTCs/7.5 mL blood at any post-baseline measurement. The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1.
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a PSA Response
Tidsramme: Cycle 1 Day 1 to 5 months post-last dose of acapatamab/AMG 404 (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)

A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:

  • PSA 30 response: ≥ 30% reduction from the baseline PSA.
  • PSA 50 response: ≥ 50% reduction from the baseline PSA.
  • PSA 70 response: ≥ 70% reduction from the baseline PSA.
  • PSA 90 response: ≥ 90% reduction from the baseline PSA.

The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1.
Cycle 1 Day 1 to 5 months post-last dose of acapatamab/AMG 404 (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC0 Response
Tidsramme: From date of initial CTC0 response to the earlier of CTC0 progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Duration of CTC0 response was defined as the time from the date of initial CTC0 response to the earlier of CTC0 progression or death. Participants who had not ended their response at the time of analysis had duration of CTC0 response censored on the date of their last CTC0 or CTC conversion assessment.
From date of initial CTC0 response to the earlier of CTC0 progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC Conversion Response
Tidsramme: From the date of an initial CTC conversion response to the earlier of CTC conversion progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Duration of CTC conversion response was defined as the time from the date of an initial CTC conversion response to the earlier of CTC conversion progression or death. Participants who had not ended their response at the time of analysis had duration of CTC response censored on the date of their last CTC0 or CTC conversion assessment.
From the date of an initial CTC conversion response to the earlier of CTC conversion progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of PSA Response
Tidsramme: From date of an initial PSA response (PSA 50) to the earlier of PSA progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Duration of PSA response was defined as the time of an initial PSA response (PSA 50) to the earlier of PSA progression or death. Participants who had not ended their response at the time of analysis had duration of PSA response censored on the date of their last PSA measurement.
From date of an initial PSA response (PSA 50) to the earlier of PSA progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of Response Per RECIST 1.1
Tidsramme: From date of an initial objective response per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Duration of response per RECIST 1.1 was defined as the time from the date of an initial objective response (CR/PR) per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death. CR/PR must have been confirmed at least 4 weeks later. Participants who had not ended their response at the time of analysis had duration of response censored at their last evaluable tumor assessment by computed tomography (CT)/magnetic resonance imaging (MRI) scan.
From date of an initial objective response per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Overall Survival (OS)
Tidsramme: From the date of study Day 1 until death due to any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
OS was defined as the time from the date of trial Day 1 until death due to any cause. OS time (months) = (date of death - trial Day 1 + 1) x 12/365.25. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was alive. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Kalbfleisch and Prentice.
From the date of study Day 1 until death due to any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Radiographic Progression Free Survival (rPFS)
Tidsramme: From trial Day 1 to the earlier of a radiographic progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
rPFS was defined as the time from trial Day 1 to radiographic progression. If a participant had no evaluable post-baseline and on-trial disease assessment and was on trial without disease progression (PD) or death recorded, rPFS was censored on the date of the first dose of the investigational product (IP). rPFS was censored at the last evaluable radiographic tumor assessment date for participants who had no PD, death or new anti-cancer therapy reported, started a new anti-cancer therapy prior to PD or death, if death recorded without new anti-cancer therapy and without PD, if death or PD immediately after more than one consecutively missed tumor assessment occurred. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to the earlier of a radiographic progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: PSA PFS
Tidsramme: From trial Day 1 to the earlier of a PSA progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
PSA PFS was defined as the interval from trial Day 1 to the earlier of a PSA progression or death from any cause; otherwise, PSA PFS was censored on the date of the last PSA measurement. If a participant had no baseline or post-baseline PSA measurement and a vital status of alive or known, PSA PFS was censored at trial Day 1. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to the earlier of a PSA progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Clinical PFS
Tidsramme: From first dose of acapatamab or AMG 404 (subprotocol C only) to clinical disease progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Clinical PFS was defined as the time from the first dose to clinical disease progression or death from any cause. If a participant had no evaluable post-baseline or on-trial disease assessment or was on trial without PD or death recorded, clinical PFS was censored on the date of the first dose of the IP. Otherwise, clinical PFS was censored on the date of last assessment. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From first dose of acapatamab or AMG 404 (subprotocol C only) to clinical disease progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Radiographic Progression
Tidsramme: From trial Day 1 to radiographic progression in the absence of subsequent anticancer therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)

Time to radiographic progression was defined as the interval from Day 1 to radiographic progression in the absence of subsequent anticancer therapy. If a participant had no evaluable post-baseline and on-trial disease assessment and was on trial without PD or death recorded, time to radiographic progression was censored on the date of the first dose of the IP. Time to radiographic progression was censored on the date of last evaluable radiographic tumor assessment for participants who:

  • had no PD but death recorded without new anti-cancer therapy;
  • had no PD, death, or new anti-cancer therapy;
  • had PD or death immediately after more than one consecutively missed tumor assessment;
  • started new anti-cancer therapy prior to PD or death, or prior to any other disease assessment if there is no PD or death.

The median was estimated using the Kaplan-Meier method and the 95% CI was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to radiographic progression in the absence of subsequent anticancer therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to PSA Progression
Tidsramme: From trial Day 1 to PSA progression (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Time to PSA progression was defined as the interval from trial Day 1 to PSA progression. If a participant had no evaluable post-baseline or on-trial PSA assessment, time to PSA progression was censored on the date of the first dose of the IP. Otherwise, time to PSA progression was censored on the date of the last PSA assessment. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to PSA progression (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Subsequent Therapy
Tidsramme: From trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Time to subsequent therapy was defined as the interval from trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy; otherwise, time to subsequent therapy was censored at the last known date of any of the trial assessments prior to initiating the subsequent cancer therapy/subsequent therapy. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Percentage of Participants Who Experienced a Gallium Prostate-specific Membrane Antigen-11 (PSMA-11) Response
Tidsramme: Cycle 1 Day 1 to 14 days post-last dose of acapatamab or AMG 404 (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
A Gallium PSMA-11 response was defined as a ≥ 50% reduction from baseline in the maximum standardized update value (SUV) using 68Gallium (68Ga)-PSMA-11 positron emission tomography (PET)/CT. PSMA-11 response percentages were based on the number of participants with a baseline PSMA assessment (defined as the last non-missing value on or prior to the pre-dose of acapatamab/AMG 404 assessments) on Cycle 1 Day 1. The 95% confidence interval was calculated based on the Clopper-Pearson method.
Cycle 1 Day 1 to 14 days post-last dose of acapatamab or AMG 404 (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Symptomatic Skeletal Events
Tidsramme: From trial Day 1 to the first symptomatic skeletal event (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Time to symptomatic skeletal events was defined as time from trial Day 1 to the first symptomatic skeletal event, otherwise time to symptomatic skeletal event was censored at the last dose of acapatamab/AMG 404 or end of safety follow-up date, whichever was later. Symptomatic skeletal events included fracture, spinal cord compression and radiation or surgery to bone. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to the first symptomatic skeletal event (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Total Alkaline Phosphatase Levels
Tidsramme: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Alkaline phosphatase levels were collected locally and centrally.
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Bone Specific Alkaline Phosphatase Levels
Tidsramme: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Bone specific alkaline phosphatase levels were collected locally and centrally.
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Lactate Dehydrogenase Levels
Tidsramme: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Lactate dehydrogenase levels were collected locally and centrally.
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Hemoglobin Levels
Tidsramme: Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
Hemoglobin levels were collected locally.
Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Neutrophil-to-lymphocyte Ratio
Tidsramme: Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
Data for the neutrophil-to-lymphocyte ratio were collected locally. Neutrophil-to-lymphocyte ratio was calculated by dividing the number of absolute neutrophils by the number of lymphocytes.
Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Urine N-telopeptide Levels
Tidsramme: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Urine N-telopeptide levels were collected centrally.
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Subprotocol A, B and C (Parts 1 and 2) and D: Maximum Serum Concentration (Cmax) of Acapatamab
Tidsramme: Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Serum concentrations of acapatamab were determined using a validated assay.
Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Subprotocol A, B and C (Parts 1 and 2) and D: Area Under the Curve Over the Dosing Interval (AUCtau)
Tidsramme: Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Serum concentrations of acapatamab were determined using a validated assay.
Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Subprotocol A, B and C (Parts 1 and 2) and D: Time to Reach Cmax (Tmax) of Acapatamab
Tidsramme: Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Serum concentrations of acapatamab were determined using a validated assay.
Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Subprotocol A, B and C (Parts 1 and 2) and D: Terminal Half-life (t1/2z) of Acapatamab
Tidsramme: Cycle 2: Days 1 to 14 (each cycle was 28 days)
Serum concentrations of acapatamab were determined using a validated assay.
Cycle 2: Days 1 to 14 (each cycle was 28 days)
Subprotocol C, Part 3: Number of Participants Who Experienced TEAEs and Treatment-related AEs
Tidsramme: From first dose of AMG 404 to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 6.14 (0.14, 105.14) weeks

A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started after the first dose of acapatamab.

A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab.

Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs.
From first dose of AMG 404 to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 6.14 (0.14, 105.14) weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Amgen

Efterforskere

  • Studieleder: MD, Amgen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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)

15. januar 2021

Primær færdiggørelse (Faktiske)

23. oktober 2023

Studieafslutning (Faktiske)

23. oktober 2023

Datoer for studieregistrering

Først indsendt

13. november 2020

Først indsendt, der opfyldte QC-kriterier

13. november 2020

Først opslået (Faktiske)

17. november 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20190505
  • 2020-001305-23 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Afidentificerede individuelle patientdata for variabler, der er nødvendige for at løse det specifikke forskningsspørgsmål i en godkendt anmodning om datadeling.

IPD-delingstidsramme

Anmodninger om datadeling i forbindelse med denne undersøgelse vil blive overvejet begyndende 18 måneder efter, at undersøgelsen er afsluttet, og enten 1) produktet og indikationen er blevet udstedt markedsføringstilladelse i både USA og Europa eller 2) den kliniske udvikling af produktet og/eller indikationen ophører og dataene vil ikke blive indsendt til de regulerende myndigheder. Der er ingen slutdato for berettigelse til at indsende en anmodning om datadeling for denne undersøgelse.

IPD-delingsadgangskriterier

Kvalificerede forskere kan indsende en anmodning, der indeholder forskningsmålene, Amgen-produktet/-erne og Amgen-undersøgelsen/-undersøgelserne i omfang, endepunkter/resultater af interesse, statistisk analyseplan, datakrav, publikationsplan og forskerens/forskernes kvalifikationer. Generelt imødekommer Amgen ikke eksterne anmodninger om individuelle patientdata med det formål at revurdere sikkerheds- og effektivitetsspørgsmål, der allerede er behandlet i produktmærkningen. Anmodninger gennemgås af et udvalg af interne rådgivere. Hvis den ikke godkendes, vil et uafhængigt datadelingspanel mægle og træffe den endelige beslutning. Efter godkendelse vil oplysninger, der er nødvendige for at løse forskningsspørgsmålet, blive leveret i henhold til vilkårene i en datadelingsaftale. Dette kan omfatte anonymiserede individuelle patientdata og/eller tilgængelige understøttende dokumenter, der indeholder fragmenter af analysekode, hvor det er angivet i analysespecifikationerne. Yderligere detaljer er tilgængelige på URL'en nedenfor.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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