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An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China (RAINFOL-02)

7 de setembro de 2026 atualizado por: Genmab

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer

The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.

Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.

All participants will receive active drug; no one will be given placebo.

This study is an extension study of the protocol GCT1184-02 (NCT06619236).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

82

Estágio

  • Fase 3

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
      • Changchun, China
        • Recrutamento
        • The First Hospital of Jilin University
      • Changsha, China
        • Recrutamento
        • Hunan Cancer Hospital
      • Chengdu, China
        • Recrutamento
        • West China Second University Hospital, Sichuan University
      • Chongqing, China
        • Recrutamento
        • Chongqing University Cancer Hospital - Chongqing Cancer Hospital
      • Guangzhou, China
        • Recrutamento
        • Sun Yat-sen University Cancer Center
      • Guangzhou, China
        • Recrutamento
        • Sun Yat-sen Memorial Hospital
      • Hangzhou, China
        • Recrutamento
        • Zhejiang Cancer Hospital
      • Harbin, China
        • Recrutamento
        • Harbin Medical University Cancer Hospital
      • Jinan, China
        • Recrutamento
        • Shandong First Medical University Affiliated Tumor Hospital
      • Nanjing, China
        • Recrutamento
        • Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
      • Shanghai, China
        • Recrutamento
        • Obstetrics & Gynecology Hospital of Fudan University
      • Shanghai, China
        • Recrutamento
        • Fudan University Shanghai Cancer Hospital
      • Shenyang, China
        • Recrutamento
        • Liaoning Cancer Hospital
      • Taiyuan, China
        • Recrutamento
        • Shanxi Cancer Hospital
      • Tianjin, China
        • Recrutamento
        • Tianjin Medical University Cancer Institute & Hospital
      • Xi'an, China
        • Recrutamento
        • The First Affiliated Hospital Of Xi'an Jiaotong University
      • Zhengzhou, China
        • Recrutamento
        • Henan Cancer 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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Key Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  • Participants may be enrolled regardless of FRα expression level.
  • Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.

  • Participants must have received prior treatment with the following therapies:

    • Platinum chemotherapy
    • Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance
    • Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations 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 unless the participant is not eligible for treatment with PARP inhibitor

  • Mirvetuximab soravtansine, if:

    • Mirvetuximab soravtansine is available in the enrollment region, and
    • The participant is eligible, and
    • The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.

  • Participants must have platinum-resistant disease:

    • Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between > 91 days and ≤ 183 days after the date of the last dose of platinum.
    • Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.

Key Exclusion Criteria:

  • Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
  • Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.
  • History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.
  • Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
  • Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
  • Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks.

NOTE: Other protocol-defined Inclusion/Exclusion criteria 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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Escolha do Investigador
Medicamento: Paclitaxel
Infusão IV
Medicamento: Gemcitabina
Infusão IV
Medicamento: Doxorrubicina lipossomal peguilada (PLD)
Infusão IV
Medicamento: Topotecano
Infusão intravenosa
Experimental: Rina-S
Medicamento: Rina-S
Infusão intravenosa (IV)
Outros nomes:
  • PRO1184
  • Rinatabart Sesutecan
  • GEN1184

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival (PFS)
Prazo: Up to approximately 16 months
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
Up to approximately 16 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival (OS)
Prazo: Up to approximately 25 months
OS is defined as the time from date of randomization to date of death due to any cause.
Up to approximately 25 months
Objective Response Rate (ORR)
Prazo: Up to approximately 25 months
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator.
Up to approximately 25 months
PFS as Determined by BICR
Prazo: Up to approximately 16 months
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on RECIST version 1.1 as determined by BICR.
Up to approximately 16 months
ORR as Determined by BICR
Prazo: Up to approximately 25 months
ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR.
Up to approximately 25 months
Duration of Response (DOR)
Prazo: Up to approximately 25 months
DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and by blinded independent central review (BICR).
Up to approximately 25 months
Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
Prazo: Up to approximately 25 months
A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline.
Up to approximately 25 months
Time to Second Disease Progression or Death From any Cause (PFS2)
Prazo: Up to approximately 25 months
PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death.
Up to approximately 25 months
Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol)
Prazo: Baseline, up to approximately 25 months
Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire. The score ranges from 0 to 100. A high scale score represents a higher response level.
Baseline, up to approximately 25 months
Time to Deterioration (TTD) in the GHS/Qol Score
Prazo: Up to approximately 25 months
TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score. A longer TTD indicates a better outcome.
Up to approximately 25 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Prazo: Up to approximately 25 months
Up to approximately 25 months

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)

26 de junho de 2026

Conclusão Primária (Estimado)

1 de setembro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

18 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • GCT1184-02 Extension Study
  • CTR20253987 (Identificador de registro: ChinaDrugTrials.org.cn)

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

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado 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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