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Estudo de REGN5678 (Anti-PSMAxCD28) com Cemiplimabe (Anti-PD-1) em pacientes com câncer de próstata metastático resistente à castração

3 de novembro de 2026 atualizado por: Regeneron Pharmaceuticals

Um estudo de fase 1/2 de REGN5678 (Anti-PSMAxCD28) com Cemiplimabe (Anti-PD-1) em pacientes com câncer de próstata metastático resistente à castração

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug[s]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.

The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.

This study is looking at several other research questions, including:

  1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab
  2. How REGN5678 alone or in combination with cemiplimab works in the body
  3. How much REGN5678 and/or cemiplimab are present in the blood
  4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

345

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.

Contato de estudo

Locais de estudo

  • Coréia do Sul
      • Seoul, Coréia do Sul, 05505
        • Recrutamento
        • Asan Medical Center
      • Seoul, Coréia do Sul, 03722
        • Recrutamento
        • Yonsei University - Severance Hospital - Colorectal Cancer Clinic
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Coréia do Sul, 16247
        • Recrutamento
        • The Catholic University of Korea - St. Vincent's Hospital - Lung Cancer Center
  • Estados Unidos
    • Arizona
      • Gilbert, Arizona, Estados Unidos, 85234
        • Recrutamento
        • Banner MD Anderson Cancer Center
      • Phoenix, Arizona, Estados Unidos, 85054
        • Recrutamento
        • Mayo Clinic
      • Tucson, Arizona, Estados Unidos, 85724
        • Recrutamento
        • University of Arizona
    • California
      • Santa Monica, California, Estados Unidos, 90404
        • Recrutamento
        • John Wayne Cancer Institute (JWCI)
    • Colorado
      • Denver, Colorado, Estados Unidos, 80218
        • Recrutamento
        • Sarah Cannon Research Institute (SCRI)
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Recrutamento
        • Yale University Hospital
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224
        • Recrutamento
        • Mayo Clinic Jacksonville
      • Tampa, Florida, Estados Unidos, 33612
        • Recrutamento
        • Moffitt Cancer Center - McKinley Drive
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Recrutamento
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Recrutamento
        • Henry Ford Health
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Recrutamento
        • Mayo Clinic
    • New York
      • New York, New York, Estados Unidos, 10029
        • Recrutamento
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Estados Unidos, 10461
        • Recrutamento
        • Montefiore Medical Center
      • New York, New York, Estados Unidos, 10016
        • Recrutamento
        • NYU Langone Health Perlmutter Cancer Center
      • New York, New York, Estados Unidos, 10032
        • Recrutamento
        • Columbia University - The Trustees of Columbia University in the City of New York
      • Rochester, New York, Estados Unidos, 14642
        • Recrutamento
        • University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Recrutamento
        • James Cancer Hospital and Solove Research Institute
    • Oregon
      • Portland, Oregon, Estados Unidos, 97213
        • Retirado
        • Providence Portland Medical Center
      • Portland, Oregon, Estados Unidos, 97239
        • Recrutamento
        • Oregon Health & Science University (3485 S. Bond)
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Recrutamento
        • Thomas Jefferson University Hospital
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Recrutamento
        • Lifespan Cancer Institute
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Recrutamento
        • MD Anderson Cancer Center
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
        • Recrutamento
        • Emily Couric Clinical Cancer Center
    • West Virginia
      • Morgantown, West Virginia, Estados Unidos, 26506
        • Recrutamento
        • West Virginia University

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 e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Key Inclusion Criteria:

mCRPC cohorts (men):

  1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.

  2. PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.

  3. Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy [ADT]) including at least:

    1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
    2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol

ccRCC cohorts (men and women):

  1. Histologically or cytologically confirmed RCC with a clear-cell component.
  2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria
  3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) [PD-1]/Programmed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor

Key Exclusion Criteria:

  1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol
  2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol
  3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC
  4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.
  5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol
  6. Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
  7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol
  8. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living [ADLs]) or uncontrolled seizures in the year prior to first dose of study therapy
  9. Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

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: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: mCRPC - dose escalation cohort

REGN5678 with or without cemiplimab
Medicamento: REGN5678

Administered as per the protocol

Outros nomes:
  • Nezastomig
Medicamento: Cemiplimab

Administered as per the protocol

Outros nomes:
  • REGN2810
  • LIBTAYO
Experimental: mCRPC - dose expansion cohort

REGN5678 with or without cemiplimab
Medicamento: REGN5678

Administered as per the protocol

Outros nomes:
  • Nezastomig
Experimental: ccRCC - dose escalation cohort

REGN5678 with or without cemiplimab
Medicamento: REGN5678

Administered as per the protocol

Outros nomes:
  • Nezastomig
Medicamento: Cemiplimab

Administered as per the protocol

Outros nomes:
  • REGN2810
  • LIBTAYO
Experimental: ccRCC - dose expansion cohort

REGN5678 with or without cemiplimab
Medicamento: REGN5678

Administered as per the protocol

Outros nomes:
  • Nezastomig

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Prazo: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence and severity of Adverse Event of Special Interests (AESIs)
Prazo: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence and severity of Serious Adverse Events (SAEs)
Prazo: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Number of participants with Grade ≥3 laboratory abnormalities
Prazo: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence of Dose-Limiting Toxicities (DLTs)
Prazo: First dose through day 42 of last participant in each dose level

Dose Escalation Phase
First dose through day 42 of last participant in each dose level
Concentration of REGN5678 in serum over time
Prazo: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Concentration of REGN5678 in combination with cemiplimab in serum over time
Prazo: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Composite Response Rate (CRR) of 50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic response of complete (CR) or partial response (PR)
Prazo: Through study completion, up to 5 years

Dose Expansion Phase - mCRPC cohort
Through study completion, up to 5 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Prazo: Through study completion, up to 5 years

Dose Expansion Phase - ccRCC cohort
Through study completion, up to 5 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
CRR of 50% decline of PSA and/or confirmed radiographic of CR or PR
Prazo: Through study completion, up to 5 years

Dose Escalation Phase - mCRPC cohort
Through study completion, up to 5 years
ORR per RECIST 1.1 criteria
Prazo: Through study completion, up to 5 years

Dose Escalation Phase - ccRCC cohort
Through study completion, up to 5 years
Incidence and severity of TEAEs
Prazo: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Incidence and severity of AESIs
Prazo: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Incidence and severity of SAEs
Prazo: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Number of participants with grade ≥3 laboratory abnormalities
Prazo: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Concentration of REGN5678 in serum over time
Prazo: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Concentration of REGN5678 in combination with cemiplimab in serum over time
Prazo: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Percentage of participants with ≥50% decline of PSA
Prazo: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases - mCRPC cohorts
Through study completion, up to 5 years
Percentage of participants with ≥90% decline of PSA
Prazo: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases- mCRPC cohorts
Through study completion, up to 5 years
Presence or absence of antibodies against REGN5678
Prazo: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases
Through study completion, up to 5 years
Presence or absence of antibodies against cemiplimab
Prazo: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases
Through study completion, up to 5 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Regeneron Pharmaceuticals

Investigadores

  • Diretor de estudo: Clinical Trials Management, Regeneron Pharmaceuticals

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)

12 de agosto de 2019

Conclusão Primária (Estimado)

15 de novembro de 2027

Conclusão do estudo (Estimado)

15 de novembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

30 de maio de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de maio de 2019

Primeira postagem (Real)

3 de junho de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • R5678-ONC-1879

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

All individual patient data (IPD) that underlie publicly available results will be considered for sharing

Prazo de Compartilhamento de IPD

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

Critérios de acesso de compartilhamento IPD

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • ANALYTIC_CODE
  • 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 .

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