Um estudo de JNJ-69086420, um anticorpo marcado com actínio-225 direcionado à calicreína-2 humana (hK2) para câncer de próstata avançado
Um estudo de fase 1 de JNJ-69086420, um anticorpo marcado com actínio-225 direcionado à calicreína-2 humana (hK2) para câncer de próstata avançado
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-69086420 in Part 1 (Dose Escalation), to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion), to determine safety of JNJ-69086420 at the RP2D(s) as a combination therapy in Part 3 (combination therapy) and to determine safety of JNJ-69086420 at the RP2D(s) in participants with metastatic hormone-sensitive prostate cancer (mHSPC) in Part 4.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Arizona
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Phoenix, Arizona, Estados Unidos, 85054
- Mayo Clinic Arizona
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic in Florida
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70006
- East Jefferson General Hospital
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University Hospital & Clinics
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Rochester
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68130
- XCancer Omaha / Urology Cancer Center
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New York
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Cancer Center
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Case Western Reserve University
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- University of Utah Huntsman Cancer Institute
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- For Part 1, Part 2, Part 3: Metastatic castration resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma (adenocarcinoma with small-cell or neuroendocrine features is allowed) with prior exposure to at least one androgen receptor (AR) targeted therapy (for example [e.g.], abiraterone acetate, enzalutamide, apalutamide, darolutamide). In addition: Part 1: prior taxane or other chemotherapy is acceptable but not required. Part 2a: prior taxane or other chemotherapy required, Part 2b: no prior taxane or other chemotherapy, Part 2c: mCRPC that has progressed after prior treatment with lutetium Lu-177 vipivotide tetraxetan, with or without prior chemotherapy, Part 3: prior taxane or other chemotherapy is acceptable but not required & For Part 4a: metastatic HSPC, For Part 4b: disease that can be treated with less than or equal to (<=) 5 radiation fields and no visceral metastases
- Parts 1, 2 & 3: Prior orchiectomy or medical castration, or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose of study drug and must continue this therapy throughout the treatment phase. This criterion does not apply to Part 4
- Palliative radiotherapy (e.g. soft tissue lesions) must be completed greater than (>) 2 weeks prior to start of study drug except for palliative radiotherapy for pain (e.g., bone pain), which may be used any time prior to first dose
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ functions as reflected in laboratory parameters
Exclusion Criteria:
- Prior treatment with radium Xofigo (Ra 223 dichloride), strontium, samarium, or other radioconjugate therapy, other systemic anti-neoplastic therapy <=30 days prior to the first dose of study drug except for luteinizing hormone-releasing hormone agonists/antagonists or GnRH agonists/antagonists. Novel androgen axis drugs <=14 days prior to the first dose of study drug. In addition: Part 2b: Must not have received prior treatment with chemotherapy (eg, docetaxel) or poly ADP ribose polymerase (PARP) inhibitors, Part 2c: Prior treatment with lutetium Lu-177 vipivotide tetraxetan is required, but must have been completed >42 days prior to first dose of study drug, Part 3: Must not have received prior treatment with JNJ-78278343, Part 4: Must not have received ADT or AR-targeted therapy less than or equal to (<=) 56 days prior to first dose of study drug
- Known history of myelodysplastic syndrome, leukemia, or hematological malignancy with features suggestive of myelodysplastic syndrome/acute myeloid leukemia at any timepoint
- Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, radiation tissue fibrosis, or peripheral neuropathy)
- Known allergies, hypersensitivity, or intolerance to JNJ-69086420 or its excipients and protein therapeutics. For Part 3, known allergies, hypersensitivity, or intolerance to JNJ-78278343 or its excipients or protein therapeutics
- Active or chronic hepatitis B or hepatitis C infection
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Part 1: Dose Escalation
Participants will receive JNJ-69086420 with one or multiple doses. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. |
Participants will receive JNJ-69086420.
Outros nomes:
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Experimental: Part 2: Dose Expansion
Participants in one or more cohorts will receive JNJ-69086420 at the RP2D(s) determined in Part 1. |
Participants will receive JNJ-69086420.
Outros nomes:
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Experimental: Part 3: Combination Therapy
Participants will receive JNJ-69086420 at the determined RP2D(s) and fixed dose of JNJ-78278343. |
Participants will receive JNJ-69086420.
Outros nomes:
Participants will receive JNJ-78278343. |
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Experimental: Part 4: HSPC Expansion
Participants with HSPC will receive JNJ-69086420 at the RP2D(s) in Part 4(a), and JNJ-69086420 following stereotactic body radiation therapy in Part 4(b). |
Participants will receive JNJ-69086420.
Outros nomes:
Participants will receive stereotactic body radiaition therapy. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Prazo: Up to 2 years and 4 months
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 2 years and 4 months
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Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Prazo: Up to 2 years and 4 months
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Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. |
Up to 2 years and 4 months
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Number of Participants with AEs by Severity
Prazo: Up to 2 years and 4 months
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Up to 2 years and 4 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants with Prostate Specific Antigen (PSA) Response
Prazo: Up to 2 years and 4 months
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PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline and that is subsequently confirmed. |
Up to 2 years and 4 months
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Overall Response Rate (ORR)
Prazo: Up to 2 years and 4 months
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ORR is defined as the percentage of participants who have a Partial Response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3). |
Up to 2 years and 4 months
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Maximum Observed Serum Concentration/Radioactivity (Cmax) of JNJ-69086420
Prazo: Up to 2 years and 4 months
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Cmax is defined as the maximum observed serum concentration/radioactivity of JNJ-69086420. |
Up to 2 years and 4 months
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Time to Reach Maximum Observed Serum Concentration/Radioactivity (Tmax) of JNJ-69086420
Prazo: Up to 2 years and 4 months
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Tmax is defined as time to reach maximum observed serum concentration/radioactivity of JNJ-69086420. |
Up to 2 years and 4 months
|
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Area Under the Serum Concentration-time Curve From Time Zero to t Time (AUC[0-t]) of JNJ-69086420
Prazo: Up to 2 years and 4 months
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AUC(0-t) is defined as the area under the serum concentration-time curve from time zero to t of JNJ-69086420. |
Up to 2 years and 4 months
|
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Number of Participants With Anti-JNJ-69086420 Antibodies
Prazo: Up to 2 years and 4 months
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Number of participants with anti-JNJ-69086420 antibodies will be assessed to evaluate the potential immunogenicity. |
Up to 2 years and 4 months
|
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Part 3: Serum Concentration of JNJ-78278343
Prazo: Up to 2 years and 4 months
|
Venous blood samples will be collected for assessment of serum concentrations of JNJ-78278343. |
Up to 2 years and 4 months
|
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Part 3:Number of Participants With Anti-JNJ-78278343 Antibodies
Prazo: Up to 2 years and 4 months
|
Number of participants with anti-JNJ-78278343 antibodies will be assessed to evaluate the potential immunogenicity. |
Up to 2 years and 4 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Neoplasias Genitais Masculinas
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Genitais, Masculino
- Doenças prostáticas
- Doenças Urogenitais Masculinas
- Neoplasias por Tipo Histológico
- Neoplasias Glandulares e Epiteliais
- Carcinoma
- Neoplasias prostáticas
- Adenocarcinoma
- Técnicas de investigação
- Terapêutica
- Procedimentos cirúrgicos, operatórios
- Radioterapia
- Técnicas estereotáxicas
- Procedimentos neurocirúrgicos
- Radiocirurgia
Outros números de identificação do estudo
- CR108817
- 69086420PCR1001 (Outro identificador: Janssen Research & Development, LLC)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informações sobre medicamentos e dispositivos, documentos de estudo
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