Segurança e eficácia de terapias para câncer de próstata metastático resistente à castração (mCRPC)
4 de agosto de 2026 atualizado por: Amgen
Um protocolo mestre avaliando a segurança e a eficácia de terapias para câncer de próstata metastático resistente à castração (mCRPC)
Este é um protocolo mestre projetado para avaliar a segurança e a eficácia das terapias em investigação em participantes com câncer de próstata metastático resistente à castração (mCRPC).
Visão geral do estudo
Status
Rescindido
Intervenção / Tratamento
Descrição detalhada
Este é um protocolo mestre projetado para avaliar a segurança, tolerabilidade e dose máxima tolerada (MTD) ou dose recomendada de fase 2 (RP2D) e eficácia de Acapatamab, em combinação com enzalutamida, abiraterona ou o inibidor de PD1 AMG 404, monoterapia AMG 404 , bem como monoterapia com Acapatamab, em participantes com câncer de próstata metastático resistente à castração (mCRPC).
Tipo de estudo
Intervencional
Inscrição (Real)
55
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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New South Wales
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Darlinghurst, New South Wales, Austrália, 2010
- St Vincents Hospital Sydney
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København Ø, Dinamarca, 2100
- Rigshospitalet
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Navarre
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Pamplona, Navarre, Espanha, 31008
- Clinica Universidad de Navarra
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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California
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Orange, California, Estados Unidos, 92868
- University of California at Irvine Medical Center
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San Francisco, California, Estados Unidos, 94158
- University of California San Francisco Mission Bay Campus
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Norton Cancer Institute
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Texas
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Dallas, Texas, Estados Unidos, 75390
- University of Texas Southwestern Medical Center
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Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson Cancer Center
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Sutton, Reino Unido, SM2 5PT
- Royal Marsden Hospital
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Lund, Suécia, 221 85
- Skånes universitetssjukhus
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Stockholm, Suécia, 171 76
- Karolinska Universitetssjukhuset Solna
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Uppsala, Suécia, 75185
- Akademiska sjukhuset
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 99 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Descrição
Todas as partes
Critério de inclusão:
- ≥ 18 anos de idade (ou idade legal de adulto no país)
- O sujeito forneceu consentimento informado antes do início de quaisquer atividades/procedimentos específicos do estudo
- Indivíduos com mCRPC com adenocarcinoma da próstata confirmado histológica ou citologicamente
- Os indivíduos devem ter sido submetidos a orquiectomia bilateral ou devem estar em terapia contínua de privação de androgênio com um agonista ou antagonista do hormônio liberador de gonadotrofina (testosterona ≤ 50 ng/dL (ou 1,7 nmol/L))
Critério de exclusão:
- Metástases do sistema nervoso central (SNC) ou doença leptomeníngea
- História ou presença de patologia do SNC clinicamente relevante
- História confirmada ou doença autoimune atual ou outras doenças que requerem terapia imunossupressora permanente
- Infarto do miocárdio, hipertensão não controlada, angina instável, arritmia cardíaca com necessidade de medicação e/ou insuficiência cardíaca congestiva sintomática (New York Heart Association > classe II) em 12 meses
- Tratamento prévio com um taxano para mCRPC
- Cirurgia de grande porte e/ou radioterapia em 4 semanas
Histórico ou evidência de infecção por coronavírus 2 da síndrome respiratória aguda grave (SARS-CoV-2), a menos que acordado com o monitor médico e que atenda aos seguintes critérios:
- Teste negativo para RNA de SARS-CoV-2 por reação em cadeia da polimerase em tempo real (RT-PCR) dentro de 72 horas após a primeira dose de Acapatamab (ou AMG 404 na Parte 3)
- Nenhum sintoma agudo da doença de COVID-19 dentro de 10 dias antes da primeira dose de Acapatamab (ou AMG 404 na Parte 3) (contado a partir do dia do teste positivo para indivíduos assintomáticos)
Experiência anterior/simultânea em estudos clínicos
- Atualmente recebendo tratamento em outro dispositivo de investigação ou estudo de medicamento, ou menos de 4 semanas desde o término do tratamento em outro dispositivo de investigação ou estudo(s) de medicamento. Outros procedimentos investigativos durante a participação neste estudo são excluídos, com exceção de varreduras investigativas.
Subprotocolo A apenas:
Critério de inclusão
• Indivíduos que planejam receber enzalutamida pela primeira vez para mCRPC
Critério de exclusão
- Uso de fortes inibidores de CYP2C8 ou fortes indutores de CYP3A4
- Uso de medicamentos de índice terapêutico estreito que são substratos do CYP3A4, CYP2C9 ou CYP2C19
Apenas subprotocolo B:
Critério de inclusão
- Indivíduos que planejam receber abiraterone pela primeira vez para critérios de exclusão mCRPC
- Insuficiência hepática moderada e grave basal (Child-Pugh Classes B e C)
- Presença de hipertensão não controlada, hipocalemia ou retenção hídrica
- História ou presença de insuficiência adrenocortical
- Uso concomitante de medicamentos que são substratos sensíveis para CYP2D6 com um índice terapêutico estreito
- Uso de indutores fortes do CYP3A4
Subprotocolo C apenas:
Critério de inclusão
- Indivíduos que são refratários a uma nova terapia antiandrogênica. Os indivíduos devem ser inelegíveis ou recusar a terapia com taxano.
- Evidência de doença progressiva, definida como 1 ou mais critérios do PCWG3: nível de PSA >/= 1 ng/mL que aumentou em pelo menos 2 ocasiões sucessivas com intervalo de pelo menos 1 semana, progressão nodal ou visceral conforme definido pelo RECIST 1.1 com modificações do PCGW3, e/ou aparecimento de 2 ou mais novas lesões na cintilografia óssea Critérios de exclusão
- História ou evidência de doença pulmonar intersticial ou pneumonite não infecciosa ativa
- Indivíduos em um inibidor anterior de PD-1 ou PD-L1 que experimentaram um evento adverso relacionado ao sistema imunológico de grau 3 ou superior antes do primeiro dia da dose
Subprotocolo D apenas:
Critério de inclusão
- Os indivíduos podem ter recebido novas terapias hormonais (NHT; por exemplo, abiraterona, enzalutamida, apalutamida ou darolutamida) para câncer de próstata, mas não mais do que 1 NHT para câncer de próstata metastático
- Inelegíveis ou recusam a terapia com taxano
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Acapatamab e Enzalutamida: Exploração de Dose
A parte de exploração da dose do estudo estimará a MTD/dose recomendada de fase 2 (RP2D) de Acapatamab em combinação com enzalutamida.
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Acapatamab será administrado como uma infusão intravenosa (IV).
Outros nomes:
A enzalutamida será administrada por via oral.
Outros nomes:
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Experimental: Acapatamab e Enzalutamida: Expansão da Dose
Após a exploração da dose, a expansão da dose será conduzida para confirmar a segurança e tolerabilidade da dose selecionada e para avaliar ainda mais a eficácia de Acapatamab em combinação com enzalutamida.
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Acapatamab será administrado como uma infusão intravenosa (IV).
Outros nomes:
A enzalutamida será administrada por via oral.
Outros nomes:
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Experimental: Acapatamab e Abiraterone: Dose Exploration
A parte de exploração da dose do estudo estimará a MTD/dose recomendada de fase 2 (RP2D) de Acapatamab em combinação com abiraterona.
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Acapatamab será administrado como uma infusão intravenosa (IV).
Outros nomes:
A abiraterona será administrada por via oral.
Outros nomes:
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Experimental: Acapatamab e Abiraterone: expansão da dose
Após a exploração da dose, a expansão da dose será conduzida para confirmar a segurança e tolerabilidade da dose selecionada e para avaliar ainda mais a eficácia de Acapatamab em combinação com abiraterona.
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Acapatamab será administrado como uma infusão intravenosa (IV).
Outros nomes:
A abiraterona será administrada por via oral.
Outros nomes:
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Experimental: Acapatamab e AMG 404: Exploração de Dose
A parte de exploração de dose do estudo estimará o MTD/RP2D de Acapatamab em combinação com AMG 404.
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Acapatamab será administrado como uma infusão intravenosa (IV).
Outros nomes:
AMG 404 será administrado como uma infusão intravenosa (IV).
Outros nomes:
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Experimental: Acapatamab e AMG 404: expansão da dose
Após a exploração da dose, a expansão da dose será conduzida para confirmar a segurança e tolerabilidade da dose selecionada e para avaliar ainda mais a eficácia do Acapatamab em combinação com AMG 404.
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Acapatamab será administrado como uma infusão intravenosa (IV).
Outros nomes:
AMG 404 será administrado como uma infusão intravenosa (IV).
Outros nomes:
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Comparador Ativo: AMG 404 Monoterapia
A monoterapia com AMG 404 está sendo conduzida para avaliar a atividade antitumoral preliminar da inibição de PD-1 na população mCRPC.
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AMG 404 será administrado como uma infusão intravenosa (IV).
Outros nomes:
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Experimental: Acapatamab e Enzalutamida: Coorte Ásia de Expansão de Dose
Após a exploração da dose, a expansão da dose será conduzida na coorte da Ásia na combinação MTD/RP2D determinada na exploração da dose para confirmar a segurança, tolerabilidade e PK de Acapatamab em combinação com enzalutamida para indivíduos na Ásia.
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Acapatamab será administrado como uma infusão intravenosa (IV).
Outros nomes:
A enzalutamida será administrada por via oral.
Outros nomes:
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Experimental: Acapatamab e Abiraterone: Expansão de Dose Coorte da Ásia
Após a exploração da dose, a expansão da dose será conduzida na coorte da Ásia na combinação MTD/RP2D determinada na exploração da dose para confirmar a segurança, tolerabilidade e PK de Acapatamab em combinação com abiraterona para indivíduos na Ásia.
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Acapatamab será administrado como uma infusão intravenosa (IV).
Outros nomes:
A abiraterona será administrada por via oral.
Outros nomes:
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Experimental: Acapatamab e AMG 404: Coorte da Ásia de Expansão de Dose
Após a exploração da dose, a expansão da dose será conduzida na coorte da Ásia na combinação MTD/RP2D determinada na exploração da dose para confirmar a segurança, tolerabilidade e PK de Acapatamab em combinação com AMG 404 para indivíduos na Ásia.
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Acapatamab será administrado como uma infusão intravenosa (IV).
Outros nomes:
AMG 404 será administrado como uma infusão intravenosa (IV).
Outros nomes:
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Experimental: Monoterapia com Acapatamabe
A monoterapia com acapatamab está sendo conduzida para avaliar a segurança, tolerabilidade, farmacocinética (PK), farmacodinâmica e eficácia de Acapatamab em indivíduos com mCRPC.
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Acapatamab será administrado como uma infusão intravenosa (IV).
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Prazo: Cycle 1: Day 1 to Day 28 (28-day cycle)
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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:
The complete list of DLTs are described in the protocol |
Cycle 1: Day 1 to Day 28 (28-day cycle)
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Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs
Prazo: 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
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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
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Subprotocol D: Number of Participants Who Experienced TEAEs and Treatment-related AEs
Prazo: 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
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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
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Subprotocol C, Part 3: Objective Response Rate (ORR)
Prazo: 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
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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.
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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
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Subprotocol C, Part 3: Percentage of Participants Who Experienced a Circulating Tumor Cell 0 (CTC0) Response
Prazo: 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)
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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.
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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)
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Subprotocol C, Part 3: Percentage of Participants Who Experienced a CTC Conversion Response
Prazo: 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)
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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.
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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)
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Subprotocol C, Part 3: Percentage of Participants Who Experienced a Prostate Specific Antigen (PSA) Response
Prazo: 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)
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A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:
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)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Subprotocols A. B, C (Parts 1 and 2) and D: ORR
Prazo: 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)
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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.
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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)
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Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC0 Response
Prazo: 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)
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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.
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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)
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Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC Conversion Response
Prazo: 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)
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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.
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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)
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Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a PSA Response
Prazo: 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)
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A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:
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)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC0 Response
Prazo: 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)
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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.
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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)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC Conversion Response
Prazo: 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)
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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.
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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)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of PSA Response
Prazo: 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)
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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.
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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)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of Response Per RECIST 1.1
Prazo: 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)
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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.
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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)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Overall Survival (OS)
Prazo: 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)
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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.
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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)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Radiographic Progression Free Survival (rPFS)
Prazo: 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)
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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.
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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)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: PSA PFS
Prazo: 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)
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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.
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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)
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Subprotocols A, B, C (Parts 1, 2 and 3) and D: Clinical PFS
Prazo: 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)
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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)
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|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Radiographic Progression
Prazo: 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:
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)
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|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to PSA Progression
Prazo: 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)
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|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Subsequent Therapy
Prazo: 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
Prazo: 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)
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|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Symptomatic Skeletal Events
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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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)
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Subprotocol A, B and C (Parts 1 and 2) and D: Area Under the Curve Over the Dosing Interval (AUCtau)
Prazo: Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
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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)
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Subprotocol A, B and C (Parts 1 and 2) and D: Time to Reach Cmax (Tmax) of Acapatamab
Prazo: 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)
|
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Subprotocol A, B and C (Parts 1 and 2) and D: Terminal Half-life (t1/2z) of Acapatamab
Prazo: Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Serum concentrations of acapatamab were determined using a validated assay.
|
Cycle 2: Days 1 to 14 (each cycle was 28 days)
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Subprotocol C, Part 3: Number of Participants Who Experienced TEAEs and Treatment-related AEs
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: MD, Amgen
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de janeiro de 2021
Conclusão Primária (Real)
23 de outubro de 2023
Conclusão do estudo (Real)
23 de outubro de 2023
Datas de inscrição no estudo
Enviado pela primeira vez
13 de novembro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de novembro de 2020
Primeira postagem (Real)
17 de novembro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de agosto de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- mCRPC
- Acapatamab
- MORDIDA DE MEIA-VIDA ESTENDIDA (HLE)
- Câncer de Próstata Metastático Resistente à Castração
- 68
- Membrana específica da próstata de gálio (68Ga)
- antígeno (PSMA)-11 emissão de pósitrons
- tomografia (PET)/tomografia computadorizada (TC)
- e
- 18
- F-fluorodesoxiglicose (FDG) PET/CT
- avaliação de resposta baseada
- Ativador de células T biespecíficos
- MORDER
Termos MeSH relevantes adicionais
- Ferimentos e Lesões
- Distúrbios induzidos quimicamente
- Envenenamento
- Mordidas e Picadas
- Agentes Antineoplásicos Imunológicos
- Agentes Antineoplásicos
- Efeitos fisiológicos das drogas
- Mecanismos Moleculares de Ação Farmacológica
- Hormônios, substitutos hormonais e antagonistas hormonais
- Antagonistas hormonais
- Antagonistas andrógenos
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Ações farmacológicas
- Ações e usos químicos
- Usos terapêuticos
- Enzimas
- Enzimas e coenzimas
- Oxidoredutases
- Citocromos
- Oxigenases de Função Mista
- Oxigenases
- Hemeproteínas
- Inibidores de Ponto de Verificação Imunológica
- Antagonistas do receptor de androgênio
- ABIRATERONE
- enzalutamida
- Sistema de enzima P-450 do citocromo
Outros números de identificação do estudo
- 20190505
- 2020-001305-23 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Dados de pacientes individuais não identificados para variáveis necessárias para abordar a questão de pesquisa específica em uma solicitação de compartilhamento de dados aprovada.
Prazo de Compartilhamento de IPD
As solicitações de compartilhamento de dados relacionadas a este estudo serão consideradas a partir de 18 meses após o término do estudo e 1) o produto e a indicação receberam autorização de comercialização nos EUA e na Europa ou 2) o desenvolvimento clínico do produto e/ou indicação foi descontinuado e os dados não serão submetidos a autoridades reguladoras.
Não há data final para elegibilidade para enviar uma solicitação de compartilhamento de dados para este estudo.
Critérios de acesso de compartilhamento IPD
Os pesquisadores qualificados podem enviar uma solicitação contendo os objetivos da pesquisa, o(s) produto(s) da Amgen e estudo/estudos da Amgen em escopo, parâmetros/resultados de interesse, plano de análise estatística, requisitos de dados, plano de publicação e qualificações do(s) pesquisador(es).
Em geral, a Amgen não atende a solicitações externas de dados individuais de pacientes com a finalidade de reavaliar questões de segurança e eficácia já abordadas na rotulagem do produto.
As solicitações são analisadas por um comitê de consultores internos.
Se não for aprovado, um Painel de Revisão Independente de Compartilhamento de Dados arbitrará e tomará a decisão final.
Após a aprovação, as informações necessárias para abordar a questão da pesquisa serão fornecidas sob os termos de um acordo de compartilhamento de dados.
Isso pode incluir dados anônimos de pacientes individuais e/ou documentos de suporte disponíveis, contendo fragmentos de código de análise quando fornecidos nas especificações de análise.
Mais detalhes estão disponíveis no URL abaixo.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .