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A Phase 3 Trial in Advanced Epithelioid Mesothelioma (sTEADfast)

11 de setembro de 2026 atualizado por: Vivace Therapeutics, Inc

A Phase 3, Randomized, Open-label Trial Comparing VT3989 Versus Gemcitabine or Vinorelbine in Participants With Advanced Epithelioid Mesothelioma, Who Previously Received Platinum-Based Systemic Chemotherapy and Immunotherapy

This randomized, open-label, multicenter Phase 3 trial will compare VT3989 with Investigator's choice of gemcitabine or vinorelbine in adults with advanced epithelioid pleural mesothelioma whose disease progressed after prior platinum-based systemic chemotherapy and immunotherapy.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Approximately 350 participants will be randomized 1:1 to VT3989 (Arm A) or Investigator's choice chemotherapy with gemcitabine or vinorelbine (Arm B).

VT3989 will be administered orally at 100 mg once daily for 2 weeks on treatment followed by 2 weeks off treatment in each 4-week cycle. Comparator treatment will be gemcitabine or vinorelbine using the protocol-specified regimen or local prescribing/institutional practice.

The trial includes screening, treatment, safety follow-up, and survival follow-up periods. A QTc Sub-Study will evaluate cardiac repolarization using time-matched pharmacokinetic samples and ECGs in approximately 25 Arm A participants. Overall survival is the primary endpoint; BICR-assessed progression-free survival is the key secondary endpoint.

Tipo de estudo

Intervencional

Inscrição (Estimado)

350

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

Estude backup de contato

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

Inclusion Criteria:

  • Male or female, age 18 years or older at informed consent.
  • Pathologically confirmed advanced epithelioid pleural mesothelioma previously treated with platinum-based systemic chemotherapy and immunotherapy, given sequentially or concurrently.
  • Radiologically measurable disease by modified RECIST v1.1 or RECIST v1.1.
  • ECOG: 0-1.
  • Adequate organ functions, including the liver, kidneys, and hematopoietic system.

Exclusion Criteria:

  • Active brain metastases or primary CNS (central nervous system) tumors.
  • History of leptomeningeal metastases
  • Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • Known HIV positive or active Hepatitis B or Hepatitis C
  • Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents
  • Corrected QT (QTcF) interval > 470 msec (using Fridericia's correction formula).
  • Women who are pregnant or breastfeeding
  • Non-pleural mesothelioma at initial diagnosis or an aggressive histologic type such as sarcomatoid or biphasic mesothelioma.
  • Prior treatment with a TEAD inhibitor, including VT3989 or another agent targeting the same molecular pathway.
  • Prior receipt of both comparator treatments, gemcitabine and vinorelbine, alone or in combination, or known hypersensitivity to both. A participant who received only one comparator may enroll but must not be assigned to that same comparator.

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
Experimental: Arm A - VT3989
VT3989 monotherapy in 28-day cycles until BICR-verified progression, unacceptable toxicity, withdrawal, or another protocol-specified reason.
Medicamento: VT3989
• 100 mg orally once daily for 2 weeks on treatment followed by 2 weeks off treatment (2W/2W) in each 4-week cycle
Comparador Ativo: Arm B - Investigator's Choice Chemotherapy
The Investigator selects 21-day cycle of gemcitabine or vinorelbine. Administration and dose modification may follow the protocol, local prescribing information, or institutional practice.
Medicamento: gemcitabine
• 1,000 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice
Medicamento: Vinorelbine
• 25-30 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall Survival (OS)
Prazo: Approximately 32-35 months after first randomization
Time from randomization to death from any cause. Participants without an observed death will be censored at the last date known alive or the analysis cut-off date, whichever is earlier.
Approximately 32-35 months after first randomization

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival by BICR
Prazo: From randomization through radiologic progression, death, up to approximately 3 years or more
Time from randomization to the first BICR-assessed radiologic progressive disease or death, using protocol-defined censoring rules.
From randomization through radiologic progression, death, up to approximately 3 years or more
Treatment-Emergent Adverse Events and Serious Adverse Events
Prazo: From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.
Incidence and severity of Treatment-Emergent Adverse Events and Serious Adverse Events
From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.
Disease-related symptoms and health-related quality of life outcomes
Prazo: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Disease-related symptoms, treatment side effects, functioning, and health-related quality of life outcomes and time to deterioration.
Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Overall Response Rate by BICR
Prazo: Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Overall Response Rate by BICR Proportion with best overall response of complete response or partial response by RECIST v1.1 and/or modified RECIST v1.1, assessed by BICR.
Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Duration of Response
Prazo: From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more
Among participants with a complete or partial response, time from first documented response to progressive disease or death, with protocol-defined censoring.
From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more
Disease Control Rate by BICR
Prazo: Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Proportion with best overall response of complete response, partial response, or stable disease by RECIST v1.1 and/or modified RECIST v1.1, assessed by BICR.
Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Time to Response
Prazo: From randomization to first documented response; up to approximately 3 years or more
Time from randomization to the first documented complete or partial response by RECIST v1.1 and/or modified RECIST v1.1.
From randomization to first documented response; up to approximately 3 years or more
EORTC QLQ-LC13
Prazo: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Lung cancer- and treatment-related symptoms using the EORTC Quality of Life Questionnaire Lung Cancer Module 13.
Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
EQ-5D-5L
Prazo: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Health status and health-related quality of life using the EuroQol 5 Dimension-5 Levels instrument.
Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Time to Deterioration
Prazo: From baseline/randomization through protocol-defined deterioration; up to approximately 3 years or more
Time to protocol-defined deterioration in disease-related symptoms and health-related quality of life; detailed definition will be specified in the Statistical Analysis Plan.
From baseline/randomization through protocol-defined deterioration; up to approximately 3 years or more

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Pharmacokinetic Evaluation - Cmax
Prazo: Up to Cycle 9 (each cycle is 28 days)
Peak plasma concentration of VT3989
Up to Cycle 9 (each cycle is 28 days)
Pharmacokinetic Evaluation - AUC
Prazo: Up to Cycle 9 (each cycle is 28 days)
Area under the plasma concentration versus time curve (AUC)
Up to Cycle 9 (each cycle is 28 days)
Correlation between VT3989 exposure
Prazo: Up to Cycle 9 (each cycle is 28 days)
Correlation between VT3989 exposure
Up to Cycle 9 (each cycle is 28 days)

Colaboradores e Investigadores

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

Patrocinador

Vivace Therapeutics, Inc

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 (Estimado)

1 de dezembro de 2026

Conclusão Primária (Estimado)

1 de maio de 2028

Conclusão do estudo (Estimado)

1 de janeiro de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

1 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de setembro de 2026

Primeira postagem (Real)

17 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 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

  • VT3989-003

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

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