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PRO1184 para Tumores Sólidos Avançados (RAINFOL-01)

2 de novembro de 2026 atualizado por: Genmab

Estudo de Fase 1/2 de PRO1184 em Pacientes com Tumores Sólidos Localmente Avançados e/ou Metastáticos

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.

Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

This is a Phase 1/2 study of Rina-S; also known as GEN1184, formerly known as PRO1184, a folate receptor alpha (FRα) targeted antibody-drug conjugate, to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Rina-S in participants with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma.

The study consists of multiple parts:

Part A: monotherapy cohorts

Part B: tumor-specific monotherapy dose-expansion cohorts

Part C: platinum-resistant ovarian cancer (PROC) monotherapy cohort

Part D: combination therapy cohorts

Part E: a monotherapy PROC cohort

Parts F and G: a monotherapy endometrial cancer (EC) cohort

Part H: a monotherapy PROC cohort

Part I: platinum-sensitive ovarian cancer (PSOC) cohort

Part J: a monotherapy PROC cohort

Part K: a monotherapy high-grade ovarian cancer cohort

Part L: a drug-drug interaction substudy

Participants will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.

Tipo de estudo

Intervencional

Inscrição (Estimado)

952

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

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recrutamento
        • Cancer hospital, Chinese Academy of Medical Sciences
    • China
      • Fujian, China, China
        • Recrutamento
        • Fujian Cancer Hospital
      • Guangdong, China, China
        • Recrutamento
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Henan, China, China
        • Recrutamento
        • Second Affiliated Hospital of Zhengzhou University
      • Hubei, China, China
        • Recrutamento
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Shanxi, China, China
        • Recrutamento
        • Second Hospital of Shanxi Medical University
      • Shanxi, China, China
        • Recrutamento
        • Shanxi Cancer Hospital
      • Shengyang, China, China
        • Recrutamento
        • Liaoning Cancer Hospital & Institute
      • Tianjin, China, China
        • Recrutamento
        • Tianjin Cancer Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recrutamento
        • Chongqing University Cancer Hospital
    • Hunan
      • Changsha, Hunan, China
        • Recrutamento
        • Hunan Cancer Hospital - Phase 1
      • Changsha, Hunan, China
        • Recrutamento
        • Hunan Cancer Hospital - Thoracic Medicine Dept II
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recrutamento
        • Jiangxi Maternal and Child Health Hospital
    • Jilin
      • Changchun, Jilin, China
        • Recrutamento
        • Jilin Cancer Hospital
    • Shanghai Municipality
      • Chengdu, Shanghai Municipality, China
        • Recrutamento
        • Obstetrics & Gynecology Hospital of Fudan University
      • Shanghai, Shanghai Municipality, China
        • Recrutamento
        • Fudan University Shanghai Cancer Center - Gynecologic Oncology
      • Shanghai, Shanghai Municipality, China
        • Recrutamento
        • Fudan University Shanghai Cancer Center- Phase 1
      • Shanghai, Shanghai Municipality, China
        • Recrutamento
        • Shanghai East Hospital
    • Sichuan
      • Shanghai, Sichuan, China
        • Recrutamento
        • Sichuan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recrutamento
        • Zhejiang Cancer Hospital
  • Coréia do Sul
      • Seoul, Coréia do Sul
        • Recrutamento
        • Korea Institute of Radiological and Medical Sciences
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85016
        • Recrutamento
        • USOR HonorHealth
      • Tucson, Arizona, Estados Unidos, 85711
        • Recrutamento
        • USOR Arizona Oncology Associates
    • California
      • Los Angeles, California, Estados Unidos, 90095
        • Recrutamento
        • University of California Los Angeles Medical Center
      • San Diego, California, Estados Unidos, 92093
        • Recrutamento
        • University of California, San Diego; Moores Cancer Center
      • Santa Barbara, California, Estados Unidos, 93105
        • Recrutamento
        • USOR Sansum Clinic
      • Santa Rosa, California, Estados Unidos, 95403
        • Recrutamento
        • Providence Medical Foundation
    • Florida
      • Fort Myers, Florida, Estados Unidos, 33908
        • Recrutamento
        • USOR Florida Cancer Specialists South
      • St. Petersburg, Florida, Estados Unidos, 33709
        • Recrutamento
        • USOR Florida Cancer Specialists North
      • West Palm Beach, Florida, Estados Unidos, 33401
        • Recrutamento
        • USOR Florida Cancer Specialists East
    • Georgia
      • Augusta, Georgia, Estados Unidos, 30912
        • Recrutamento
        • Augusta University Georgia Cancer Center
    • Kansas
      • Westwood, Kansas, Estados Unidos, 66205
        • Recrutamento
        • University of Kansas Medical Center (KUMC)
    • Maryland
      • Rockville, Maryland, Estados Unidos, 20850
        • Recrutamento
        • USOR Maryland Oncology Hematology
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Recrutamento
        • Massachusetts General Hospital
      • Boston, Massachusetts, Estados Unidos, 02215
        • Recrutamento
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48085
        • Recrutamento
        • Karmanos Cancer Institute
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Recrutamento
        • START Midwest
    • Minnesota
      • Maplewood, Minnesota, Estados Unidos, 55109
        • Recrutamento
        • USOR Minnesota Oncology Hematology
    • New Jersey
      • Camden, New Jersey, Estados Unidos, 08103
        • Recrutamento
        • MD Anderson Cancer Center at Cooper- Two Cooper Plaza
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Recrutamento
        • Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Recrutamento
        • University of Oklahoma - Health Sciences Center
    • Oregon
      • Eugene, Oregon, Estados Unidos, 97401
        • Recrutamento
        • USOR Oncology Associates of Oregon, P.C.
      • Portland, Oregon, Estados Unidos, 97227
        • Recrutamento
        • Compass Oncology - Rose Quarter
    • Pennsylvania
      • Doylestown, Pennsylvania, Estados Unidos, 18901
        • Recrutamento
        • USOR Alliance Cancer Specialist
      • Pittsburgh, Pennsylvania, Estados Unidos, 15224
        • Recrutamento
        • Allegheny Health Network
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02905
        • Recrutamento
        • Women and Infants Hospital of Rhode Island
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • Recrutamento
        • Tennessee Oncology
      • Nashville, Tennessee, Estados Unidos, 37203
        • Recrutamento
        • Sarah Cannon Research Institute at Tennessee Oncology
    • Texas
      • Abilene, Texas, Estados Unidos, 79606
        • Recrutamento
        • USOR Texas Oncology
      • Austin, Texas, Estados Unidos, 78758
        • Recrutamento
        • Texas Oncology - Central / South Texas
      • Dallas, Texas, Estados Unidos, 75521
        • Recrutamento
        • Mary Crowley Cancer Research
      • Fort Worth, Texas, Estados Unidos, 76104
        • Recrutamento
        • USOR Texas Oncology
      • Tyler, Texas, Estados Unidos, 75702
        • Recrutamento
        • Texas Oncology - Northeast TX
      • Woodland, Texas, Estados Unidos, 77380
        • Recrutamento
        • USOR Texas Oncology Gulf Coast
    • Utah
      • West Valley City, Utah, Estados Unidos, 84119
        • Recrutamento
        • START Mountain Region
    • Virginia
      • Fairfax, Virginia, Estados Unidos, 22031
        • Recrutamento
        • USOR Virginia Cancer Specialists
      • Norfolk, Virginia, Estados Unidos, 23502
        • Recrutamento
        • USOR Virginia Oncology Associates
    • Washington
      • Everett, Washington, Estados Unidos, 98104
        • Recrutamento
        • Swedish Cancer Institute
  • Japão
    • Fukushima
      • Fukushima, Fukushima, Japão
        • Recrutamento
        • Fukushima Medical University Hospital
    • Gunma
      • Ōta, Gunma, Japão
        • Recrutamento
        • Gunma Prefectural Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japão
        • Recrutamento
        • Sapporo Medical University Hospital
    • Hyōgo
      • Akashi, Hyōgo, Japão
        • Recrutamento
        • Hyogo Cancer Center
    • Saitama
      • Hidaka, Saitama, Japão
        • Recrutamento
        • Saitama Medical University-International Medical Center
    • Shizuoka
      • Nagaizumi-chō, Shizuoka, Japão
        • Recrutamento
        • Shizuoka Cancer Center
    • Tokyo
      • Koto, Tokyo, Japão
        • Recrutamento
        • Cancer Institute Hospital of JFCR
      • Shinjuku-ku, Tokyo, Japão
        • Recrutamento
        • Keio University Hospital
    • Yamagata
      • Yamagata, Yamagata, Japão
        • Recrutamento
        • Yamagata University Hospital

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

Inclusion Criteria:

Part A and B:

  • Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).
  • Previously received therapies known to confer clinical benefit.
  • Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.

Part C, E, and H:

Participants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.

  • High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)
  • Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
  • Participants must have platinum-resistant ovarian cancer.
  • Participants must have received prior bevacizumab or approved biosimilar.
  • Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration [FDA]-approved test in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.
  • Measurable disease per the RECIST v1.1 at baseline.

Part D:

Cohort D1:

  • Participants must have platinum-sensitive ovarian cancer.
  • Participants must have received 1 to 3 prior lines of therapy.

Cohort D2:

  • Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.

  • Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.

  • Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.

    • Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (>183 days) or more from the last dose of platinum-based therapy.

Cohort D3:

• Endometrial cancer (any subtype excluding sarcoma).

Cohort D4:

• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).

Cohort D5

• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).

Part F and G:

  • Participants must have histologically or cytologically confirmed EC.
  • Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
  • Participants must have received 1 to 3 prior lines of therapy, and must have progressed radiographically on or after their most recent line of therapy:
  • Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-[L])1 inhibitor.
  • Participants who progress >12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.
  • Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part I:

  • Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low grade/borderline ovarian tumors).
  • Participants must have platinum sensitive ovarian cancer.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part J:

  • Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part K:

  • Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).
  • Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part L:

  • Participants must have a histologically or cytologically confirmed metastatic or unresectable solid malignancy. Participants must have previously received all therapies known to confer clinical benefit (unless ineligible to receive or refused to receive or therapy is unavailable in the region). If a standard-of-care therapy is available that has not been administered, the reason that the therapy is not appropriate must be documented.
  • Participants must either have ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element), or
  • NSCLC.
  • Age 18 to 65 years (inclusive).
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Measurable disease per the RECIST version 1.1 at baseline.

Exclusion Criteria:

  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.

Note: Other protocol-defined inclusion/exclusion may 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 sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Part A, B, C, E, F, G, H, I, J and K

Rina-S monotherapy in Part A and at the recommended dose in Parts B, C, E, F, G, H, I, J and K.
Medicamento: Rina-S

Intravenous infusion of Rina-S

Outros nomes:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Experimental: Part D1

Rina-S in combination with carboplatin
Medicamento: Rina-S

Intravenous infusion of Rina-S

Outros nomes:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Medicamento: Carboplatin

Carboplatin intravenous infusion
Experimental: Part D2 and I

Rina-S in combination with bevacizumab
Medicamento: Rina-S

Intravenous infusion of Rina-S

Outros nomes:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Medicamento: Bevacizumab

Bevacizumab intravenous infusion
Experimental: Part D3, D4 and D5

Rina-S in combination with pembrolizumab
Medicamento: Rina-S

Intravenous infusion of Rina-S

Outros nomes:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Medicamento: Pembrolizumab

Pembrolizumab intravenous infusion
Experimental: Part L

Rina-S in combination with CYP3A4 inhibitors erythromycin or itraconazole.
Medicamento: Rina-S

Intravenous infusion of Rina-S

Outros nomes:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Medicamento: Erythromycin

Erythromycin oral administration

Medicamento: Itraconazole

Itraconazole oral administration

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
As partes A, B e D - incidência de eventos adversos emergentes de tratamento (TEAES) [Segurança e tolerabilidade]
Prazo: Até o final do tratamento, até aproximadamente 1 ano.
Até o final do tratamento, até aproximadamente 1 ano.
Parte K (somente participantes dos EUA) - Número de participantes com mudanças clinicamente significativas nos achados do eletrocardiograma (ECG) por Holter
Prazo: Ciclos 1 a 3 (cada ciclo é de 21 dias)
Ciclos 1 a 3 (cada ciclo é de 21 dias)
Parts A, and D - Number of Participants with Dose Limiting Toxicity (DLT)
Prazo: At the end of Cycle 1 (each cycle is 21 days)
At the end of Cycle 1 (each cycle is 21 days)
Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Prazo: Through end of treatment, up to approximately 1 year.

Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.
Through end of treatment, up to approximately 1 year.
Part L - Peak Plasma Concentration (Cmax) of Rina-S
Prazo: Cycles 1 and 2 (each cycle is 21 days)

Measurement of maximum plasma concentration after the administration of Rina-S.[
Cycles 1 and 2 (each cycle is 21 days)
Part L - Area Under the Plasma Concentration Versus Time Curve (AUC) of Rina-S
Prazo: Cycles 1 and 2 (each cycle is 21 days)

Measurement of AUC after the administration of Rina-S.
Cycles 1 and 2 (each cycle is 21 days)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Parts A, B, D, and E -Time to Reach Cmax (Tmax) for Rina-S
Prazo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts A, B, D, and E - Trough Concentrations (Ctrough) for Rina-S
Prazo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts A, B, D, and E- Apparent Terminal Half-life (t1/2) for Rina-S
Prazo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts C, D, E, H and J - CA-125 Response Determined Using the Gynecologic Cancer Intergroup (GCIG) Criteria
Prazo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Part E - Number of Participants With Antidrug Antibodies (ADA)
Prazo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts A, B, and D - Best Overall Response (BOR)
Prazo: Up to approximately 1 year.

Participants who achieve CR or PR. Best response as assessed by the investigator per RECIST v1.1 criteria for all tumor types other than pleural mesothelioma which will use modified RECIST (mRECIST) v1.1.
Up to approximately 1 year.
Parts A, B, D, and E - ORR
Prazo: Up to approximately 1 year.

Participants who achieve PR or CR per RECIST v1.1 criteria.
Up to approximately 1 year.
Parts A, B, and D - Disease Control Rate (DCR)
Prazo: Up to approximately 1 year.

Participants who achieve stable disease, PR or CR per RECIST v1.1 criteria.
Up to approximately 1 year.
Parts A, B, C, D, E, F, G, H, I, and J - Progression-Free Survival (PFS)
Prazo: Through end of treatment, up to approximately 1 year.

Time from start of treatment to first documented disease progression or death
Through end of treatment, up to approximately 1 year.
Parts C, E, F, G, H, I and J - Overall survival (OS)
Prazo: Up to approximately 2 years.

Time from the start of study treatment to the date of death from any cause
Up to approximately 2 years.
Parts A, B, C, D, E, F, G, H, I and J - Duration of Objective Response (DOR)
Prazo: From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months.

Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death
From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months.
Parts A, B, D, and E - Cmax for Rina-S
Prazo: Through end of treatment, up to approximately 1 year.

Measurement of maximum plasma concentration after the administration of Rina-S.
Through end of treatment, up to approximately 1 year.
Parts A, B, D, and E - AUC for Rina-S
Prazo: Through end of treatment, up to approximately 1 year.

Measurement of AUC after the administration of Rina-S.
Through end of treatment, up to approximately 1 year.
Parts C, E, F, G, H, I, J, K and L - Number of Participants with Type, Incidence, Severity, Seriousness as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and Relatedness of Adverse Events (AEs)
Prazo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Part L - Number of Participants with DLT
Prazo: At the end of Cycle 1 (each cycle is 21 days)
At the end of Cycle 1 (each cycle is 21 days)

Colaboradores e Investigadores

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

Patrocinador

Genmab

Investigadores

  • Diretor de estudo: Study Official, Genmab

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)

7 de dezembro de 2022

Conclusão Primária (Estimado)

1 de dezembro de 2028

Conclusão do estudo (Estimado)

1 de março de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

4 de outubro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de outubro de 2022

Primeira postagem (Real)

13 de outubro de 2022

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

2 de novembro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • GCT1184-01
  • PRO1184-001 (Outro identificador: Other Sponsor Identifier)
  • CTR20230813 (Identificador de registro: Chinadrugtrials.org.cn)
  • jRCT2051250094 (Identificador de registro: Japan Registry for Clinical Trials (jRCT))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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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