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Säkerhet och effekt av behandlingar för metastaserande kastrationsresistent prostatacancer (mCRPC)

4 augusti 2026 uppdaterad av: Amgen

Ett huvudprotokoll som utvärderar säkerheten och effektiviteten av terapier för metastaserad kastrationsresistent prostatacancer (mCRPC)

Detta är ett huvudprotokoll utformat för att utvärdera säkerheten och effekten av undersökningsterapier hos deltagare med metastaserad kastrationsresistent prostatacancer (mCRPC).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Detta är ett huvudprotokoll utformat för att utvärdera säkerhet, tolerabilitet och maximal tolererad dos (MTD) eller rekommenderad fas 2-dos (RP2D) och effektivitet av Acapatamab, i kombination med enzalutamid, abirateron eller PD1-hämmaren AMG 404, AMG 404 monoterapi , såväl som Acapatamab monoterapi, hos deltagare med metastaserad kastrationsresistent prostatacancer (mCRPC).

Studietyp

Interventionell

Inskrivning (Faktisk)

55

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 99 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Alla delar

Inklusionskriterier:

  • ≥ 18 år (eller laglig vuxen ålder inom landet)
  • Försökspersonen har lämnat informerat samtycke innan studiespecifika aktiviteter/procedurer påbörjas
  • Försökspersoner med mCRPC med histologiskt eller cytologiskt bekräftat adenokarcinom i prostata
  • Försökspersonerna ska ha genomgått bilateral orkiektomi eller ska vara på kontinuerlig androgendeprivationsterapi med en gonadotropinfrisättande hormonagonist eller -antagonist (testosteron ≤ 50 ng/dL (eller 1,7 nmol/L))

Exklusions kriterier:

  • Metastaser i centrala nervsystemet (CNS) eller leptomeningeal sjukdom
  • Historik eller närvaro av kliniskt relevant CNS-patologi
  • Bekräftad historia eller aktuell autoimmun sjukdom eller andra sjukdomar som kräver permanent immunsuppressiv terapi
  • Hjärtinfarkt, okontrollerad hypertoni, instabil angina, hjärtarytmi som kräver medicinering och/eller symptomatisk kronisk hjärtsvikt (New York Heart Association > klass II) inom 12 månader
  • Tidigare behandling med en taxan för mCRPC
  • Större operation och/eller strålning inom 4 veckor

  • Historik eller bevis för allvarligt akut respiratoriskt syndrom coronavirus 2 (SARS-CoV-2) infektion om inte överenskommits med medicinsk monitor och uppfyller följande kriterier:

    • Negativt test för SARS-CoV-2 RNA genom polymeraskedjereaktion i realtid (RT-PCR) inom 72 timmar efter första dosen av Acapatamab (eller AMG 404 i del 3)
    • Inga akuta symtom på covid-19-sjukdom inom 10 dagar före första dosen av Acapatamab (eller AMG 404 i del 3) (räknat från dagen för positivt test för asymtomatiska försökspersoner)

Tidigare/Samtidig klinisk studieerfarenhet

  • Får för närvarande behandling i en annan prövningsapparat eller läkemedelsstudie, eller mindre än 4 veckor efter avslutad behandling med en annan prövningsapparat eller läkemedelsstudie(r). Andra undersökningsförfaranden när du deltar i denna studie är uteslutna med undantag för undersökningsskanningar.

Endast underprotokoll A:

Inklusionskriterier

• Försökspersoner som planerar att få enzalutamid för första gången för mCRPC

Exklusions kriterier

  • Användning av starka CYP2C8-hämmare eller starka CYP3A4-inducerare
  • Användning av läkemedel med smalt terapeutiskt index som är substrat för CYP3A4, CYP2C9 eller CYP2C19

Endast underprotokoll B:

Inklusionskriterier

  • Försökspersoner som planerar att få abirateron för första gången för mCRPC-exklusionskriterier
  • Baslinje måttligt och gravt nedsatt leverfunktion (Child-Pugh klass B och C)
  • Förekomst av okontrollerad hypertoni, hypokalemi eller vätskeretention
  • Historik eller förekomst av binjurebarkinsufficiens
  • Användning av samtidig medicinering som är känsliga substrat för CYP2D6 med ett smalt terapeutiskt index
  • Användning av starka CYP3A4-inducerare

Endast underprotokoll C:

Inklusionskriterier

  • Patienter som är refraktära mot en ny antiandrogenterapi. Försökspersoner måste vara olämpliga för eller vägra taxanterapi.
  • Bevis på progressiv sjukdom, definierad som 1 eller flera PCWG3-kriterier: PSA-nivå >/=1 ng/ml som har ökat vid minst 2 på varandra följande tillfällen med minst 1 veckas mellanrum, nodal eller visceral progression enligt definition i RECIST 1.1 med PCGW3-modifieringar, och/eller uppkomsten av 2 eller fler nya lesioner i benskanning Exklusionskriterier
  • Historik eller tecken på interstitiell lungsjukdom eller aktiv, icke-infektiös pneumonit
  • Försökspersoner på en tidigare PD-1- eller PD-L1-hämmare som upplevde en immunrelaterad biverkning av grad 3 eller högre före den första dosen

Endast underprotokoll D:

Inklusionskriterier

  • Försökspersoner kan ha haft nya hormonella terapier (NHT; t.ex. abirateron, enzalutamid, apalutamid eller darolutamid) för prostatacancer, men inte mer än 1 NHT för metastaserad prostatacancer
  • Ej berättigad till eller vägrar taxanterapi

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Acapatamab och Enzalutamid: Dosutforskning
Dosutforskningsdelen av studien kommer att uppskatta MTD/rekommenderad fas 2-dos (RP2D) av Acapatamab i kombination med enzalutamid.
Läkemedel: Acapatamab
Acapatamab kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PSMA riktad terapi
Läkemedel: Enzalutamid
Enzalutamid kommer att administreras oralt.
Andra namn:
  • Androgenreceptorhämmare
Experimentell: Acapatamab och Enzalutamid: Dosexpansion
Efter dosutforskning kommer dosexpansion att genomföras för att bekräfta säkerheten och tolerabiliteten för den valda dosen och för att ytterligare utvärdera effekten av Acapatamab i kombination med enzalutamid.
Läkemedel: Acapatamab
Acapatamab kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PSMA riktad terapi
Läkemedel: Enzalutamid
Enzalutamid kommer att administreras oralt.
Andra namn:
  • Androgenreceptorhämmare
Experimentell: Acapatamab och Abiraterone: Dosutforskning
Dosutforskningsdelen av studien kommer att uppskatta MTD/rekommenderad fas 2-dos (RP2D) av Acapatamab i kombination med abirateron.
Läkemedel: Acapatamab
Acapatamab kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PSMA riktad terapi
Läkemedel: Abiraterone
Abirateron kommer att administreras oralt.
Andra namn:
  • Cytokrom P450 (CYP)17-hämmare
Experimentell: Acapatamab och Abiraterone: Dosexpansion
Efter dosutforskning kommer dosexpansion att genomföras för att bekräfta säkerheten och tolerabiliteten för den valda dosen och för att ytterligare utvärdera effekten av Acapatamab i kombination med abirateron.
Läkemedel: Acapatamab
Acapatamab kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PSMA riktad terapi
Läkemedel: Abiraterone
Abirateron kommer att administreras oralt.
Andra namn:
  • Cytokrom P450 (CYP)17-hämmare
Experimentell: Acapatamab och AMG 404: Dosutforskning
Dosutforskningsdelen av studien kommer att uppskatta MTD/RP2D för Acapatamab i kombination med AMG 404.
Läkemedel: Acapatamab
Acapatamab kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PSMA riktad terapi
Läkemedel: AMG 404
AMG 404 kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PD-1-hämmare
Experimentell: Acapatamab och AMG 404: Dosexpansion
Efter dosutforskning kommer dosexpansion att genomföras för att bekräfta säkerheten och tolerabiliteten för den valda dosen och för att ytterligare utvärdera effekten av Acapatamab i kombination med AMG 404.
Läkemedel: Acapatamab
Acapatamab kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PSMA riktad terapi
Läkemedel: AMG 404
AMG 404 kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PD-1-hämmare
Aktiv komparator: AMG 404 Monoterapi
AMG 404 monoterapi genomförs för att utvärdera den preliminära antitumöraktiviteten av PD-1-hämning i mCRPC-populationen.
Läkemedel: AMG 404
AMG 404 kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PD-1-hämmare
Experimentell: Acapatamab och Enzalutamid: Dosexpansion Asia Cohort
Efter dosexplorering kommer dosexpansion att genomföras i Asien-kohorten vid kombinationen MTD/RP2D fastställd i dosexplorering för att bekräfta säkerheten, tolerabiliteten och farmakokinet för Acapatamab i kombination med enzalutamid för försökspersoner i Asien.
Läkemedel: Acapatamab
Acapatamab kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PSMA riktad terapi
Läkemedel: Enzalutamid
Enzalutamid kommer att administreras oralt.
Andra namn:
  • Androgenreceptorhämmare
Experimentell: Acapatamab och Abiraterone: Dosexpansion Asia Cohort
Efter dosexplorering kommer dosexpansion att genomföras i Asien-kohorten vid kombinationen MTD/RP2D fastställd i dosexplorering för att bekräfta säkerheten, tolererbarheten och farmakologiska effekterna av Acapatamab i kombination med abirateron för försökspersoner i Asien.
Läkemedel: Acapatamab
Acapatamab kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PSMA riktad terapi
Läkemedel: Abiraterone
Abirateron kommer att administreras oralt.
Andra namn:
  • Cytokrom P450 (CYP)17-hämmare
Experimentell: Acapatamab och AMG 404: Dosexpansion Asia Cohort
Efter dosexplorering kommer dosexpansion att genomföras i Asien-kohorten vid kombinationen MTD/RP2D fastställd i dosexplorering för att bekräfta säkerheten, tolerabiliteten och farmakokinet för Acapatamab i kombination med AMG 404 för försökspersoner i Asien.
Läkemedel: Acapatamab
Acapatamab kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PSMA riktad terapi
Läkemedel: AMG 404
AMG 404 kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PD-1-hämmare
Experimentell: Acapatamab monoterapi
Acapatamab monoterapi utförs för att utvärdera säkerhet, tolerabilitet, farmakokinetik (PK), farmakodynamik och effekt av Acapatamab hos patienter med mCRPC.
Läkemedel: Acapatamab
Acapatamab kommer att administreras som en intravenös (IV) infusion.
Andra namn:
  • PSMA riktad terapi

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Subprotocols A. B, C (Parts 1 and 2) and D: ORR
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

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Sponsor

Amgen

Utredare

  • Studierektor: MD, Amgen

Publikationer och användbara länkar

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Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 januari 2021

Primärt slutförande (Faktisk)

23 oktober 2023

Avslutad studie (Faktisk)

23 oktober 2023

Studieregistreringsdatum

Först inskickad

13 november 2020

Först inskickad som uppfyllde QC-kriterierna

13 november 2020

Första postat (Faktisk)

17 november 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 augusti 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

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JA

IPD-planbeskrivning

Avidentifierade individuella patientdata för variabler som är nödvändiga för att hantera den specifika forskningsfrågan i en godkänd begäran om datadelning.

Tidsram för IPD-delning

Begäranden om datadelning relaterade till denna studie kommer att övervägas med början 18 månader efter att studien har avslutats och antingen 1) produkten och indikationen har beviljats ​​marknadsföringstillstånd i både USA och Europa eller 2) klinisk utveckling för produkten och/eller indikationen avbryts och uppgifterna kommer inte att lämnas till tillsynsmyndigheter. Det finns inget slutdatum för behörighet att skicka in en begäran om datadelning för denna studie.

Kriterier för IPD Sharing Access

Kvalificerade forskare kan lämna in en begäran som innehåller forskningsmålen, Amgen-produkten/-erna och Amgen-studien/studierna i omfattning, slutpunkter/resultat av intresse, statistisk analysplan, datakrav, publiceringsplan och forskarens/forskarnas kvalifikationer. I allmänhet beviljar Amgen inte externa förfrågningar om individuell patientdata i syfte att omvärdera säkerhets- och effektfrågor som redan behandlats i produktmärkningen. Förfrågningar granskas av en kommitté av interna rådgivare. Om det inte godkänns kommer en oberoende granskningspanel för datadelning att skilje och fatta det slutliga beslutet. Vid godkännande kommer information som är nödvändig för att hantera forskningsfrågan att tillhandahållas enligt villkoren i ett datadelningsavtal. Detta kan inkludera anonymiserade individuella patientdata och/eller tillgängliga stöddokument, som innehåller fragment av analyskod där det finns i analysspecifikationerna. Mer information finns på webbadressen nedan.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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