Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Um estudo para avaliar IPN01194 quando administrado sozinho em adultos com tumores sólidos avançados

29 de setembro de 2026 atualizado por: Ipsen

Um estudo aberto, de fase I/IIa, primeiro em humanos, de escalonamento de dose e expansão de coorte para avaliar a segurança, tolerabilidade, atividade farmacocinética, farmacodinâmica e antitumoral do inibidor ERK1/2 IPN01194 como agente único em participantes adultos com tumores sólidos avançados

The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.

The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.

In this study, all participants will receive the study drug, which will be taken by mouth (orally).

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

The study consists of two parts, called Phase I and Phase IIa.

Phase I is designed to assess the safety of increasing doses of IPN01194 in participants with specific types of advanced solid tumours.

The aim of this "dose escalation" phase is to find the dose range showing activity on the tumor that can be tolerated by the participants, and to determine the two doses for further testing in Phase IIa. Phase I will assess how the body processes and responds to the study drug when administered with and without food.

In Phase IIa, participants with selected single tumour type will be invited to take part. During this phase, the two dose levels of the study drug identified from Phase I will be tested. Participants will take the study drug one of the two dose levels. Each participant will be assigned to a dose level at random (by chance).

Each phase will consist of three periods:

  1. A period to assess eligibility (screening period) that will take up to 28 days.
  2. A treatment period of at least 28 days that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at least 30 days after the last administration of study drug.
  3. A follow-up period (Phase IIa participants only), where every 3 months, participants will be contacted by phone, until death or the study cut-off date, whichever comes first.

Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded.

If in the opinion of the investigator a participant is continuing to experience clinical benefit after the cut-off date, the participant may remain in the study and continue to receive the study drug until either disease progression, unacceptable toxicity or other withdrawal criteria are met.

Tipo de estudo

Intervencional

Inscrição (Real)

36

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.

Locais de estudo

  • Espanha
      • Barcelona, Espanha
        • Barcelona - Val D'Hebron
      • Madrid, Espanha
        • Fundacion Jimenez Diaz - Madrid
      • Madrid, Espanha
        • M.D. Anderson Cancer Center Madrid
  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90025
        • The Angeles Clinic and Research Institute - California
      • San Diego, California, Estados Unidos, 92037
        • UC San Diego Health System - La Jolla
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Yale Cancer Center - New Heaven
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • Sarah Cannon Research Institute (SCRI) - Nashville
    • Virginia
      • Fairfax, Virginia, Estados Unidos, 22031
        • Virginia Cancer Specialist
  • França
      • Lyon, França
        • Centre Léon Bérard - Lyon
      • Paris, França
        • Paris Saint-Louis
      • Saint-Herblain, França
        • Institut de Cancerologie de l'Ouest (St-Herblain)
      • Villejuif, França
        • IGR-Villejuif

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 :

  • Participants must be ≥18 years of age
  • Participants with histologically confirmed metastatic solid tumour (melanoma, metastatic colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) or head and neck squamous cell carcinoma (HNSCC)) for whom no suitable alternative standard therapy exists.
  • Participants must bear tumours harbouring selected classes of genetic mutations, (MAPKm).
  • Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1.
  • Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening
  • Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.

Exclusion Criteria

  • Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications.
  • Any evidence of severe active infection or inflammatory condition.
  • Non-adequate cardiac function
  • Have one or more of study defined ophthalmological findings/conditions
  • Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant's ability to cooperate with the requirements of the study.
  • Underlying medical conditions that, in the investigator's or sponsor's opinion, will obscure the interpretation of toxicity determination or AEs.
  • Known second malignancy within the last 2 years prior to first dose of study intervention..
  • Major surgery within 28 days prior to first dose of study intervention.
  • Ongoing AEs caused by any prior anti-cancer therapy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0).
  • Active brain metastases or leptomeningeal metastases
  • Current enrolment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days.
  • Live vaccine(s) within 28 days prior to first dose of study intervention
  • Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
  • Treatment with medications that prolong the QT/QTc interval.
  • Treatment with strong and moderate CYP3A4 inducers
  • Treatment with strong or moderate inhibitors of CYP3A4
  • Only for Phase I participants assigned to dose escalation and low-dose backfill participants: treatment with proton pump inhibitors within 14 days prior to first dose of study intervention.
  • Non-adequate bone marrow function
  • Non-adequate renal function
  • Non-adequate hepatic function
  • Non adequate coagulation function.
  • Known uncontrolled human immunodeficiency virus (HIV) infection or hepatitis B or C
  • Sensitivity to IPN01194 or any of its components.

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 sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Phase I (Dose Escalation with Backfilling)

Nine dose levels are planned to be tested.
Medicamento: IPN01194

IPN01194 will be taken orally over a period of 28 days (a "Cycle") at the assigned dose level. The dose limiting toxicity (DLT) observation period consists of the first 28 days of treatment with IPN01194 (Cycle 1).

Participants will receive IPN01194 treatment beyond Cycle 1 until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision.

Medicamento: IPN01194

All participants will receive IPN01194 orally for 28-day cycles at one of the two dose levels determined at the end of Phase I.

Participants will receive IPN01194 treatment until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision
Experimental: Phase IIa (Cohort Expansion)

Study intervention will be administered at one of two doses of interest determined at the end of Phase I.
Medicamento: IPN01194

IPN01194 will be taken orally over a period of 28 days (a "Cycle") at the assigned dose level. The dose limiting toxicity (DLT) observation period consists of the first 28 days of treatment with IPN01194 (Cycle 1).

Participants will receive IPN01194 treatment beyond Cycle 1 until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision.

Medicamento: IPN01194

All participants will receive IPN01194 orally for 28-day cycles at one of the two dose levels determined at the end of Phase I.

Participants will receive IPN01194 treatment until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Fase 1: Porcentagem de participantes com toxicidade limitante de dose (DLT)
Prazo: Dentro de 28 dias após a primeira dose
Dentro de 28 dias após a primeira dose
Fase 1: Percentagem de participantes com interrupções de dose e descontinuações permanentes do tratamento
Prazo: 30 dias após a última administração da intervenção do estudo
30 dias após a última administração da intervenção do estudo
Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs)
Prazo: At 30 days following the last administration of study intervention

An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
At 30 days following the last administration of study intervention
Phase 2a: Objective response rate (ORR)
Prazo: At end of treatment (up to approximately 32 months)

Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator.
At end of treatment (up to approximately 32 months)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Fase 1: Tempo até a concentração máxima observada do medicamento (Tmax) após doses únicas e múltiplas de IPN01194
Prazo: No dia 1 e no dia 15.
No dia 1 e no dia 15.
Fase 1: Concentração máxima observada do medicamento (Cmax) após doses únicas e múltiplas de IPN01194
Prazo: No dia 1 e no dia 15.
No dia 1 e no dia 15.
Fase 1: Razão média geométrica de Cmax de IPN01194 administrado no estado alimentado em relação ao estado de jejum
Prazo: Entre o Dia -8 e o Dia -3 (período de jejum) e entre o Dia -10 e o Dia -7 (período de estado alimentado)
Entre o Dia -8 e o Dia -3 (período de jejum) e entre o Dia -10 e o Dia -7 (período de estado alimentado)
Fase 2a: taxa de PFS em 4 meses
Prazo: Da randomização até 4 meses
Da randomização até 4 meses
Fase 2a: Porcentagem de participantes com TEAEs e TE SAEs
Prazo: No final do tratamento (até aproximadamente 32 meses)
No final do tratamento (até aproximadamente 32 meses)
Fase 2a: Percentagem de participantes com interrupções de dose e descontinuações permanentes do tratamento
Prazo: No final do tratamento (até aproximadamente 32 meses)
No final do tratamento (até aproximadamente 32 meses)
Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194
Prazo: At Day 1 and Day 15.

AUCtau is defined as the concentration of drug over one dosing interval.
At Day 1 and Day 15.
Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state
Prazo: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)

AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state
Prazo: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)

AUCinf is defined as the concentration of drug extrapolated to infinite time.
Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Phase 1: Prolongation of corrected QT interval (QTc)
Prazo: Within 28 days of first dose

Prolongation of QTc defined as the upper limit of 90% confidence interval for change from baseline QTc evaluated over Cycle 1 at the highest clinically relevant exposure.
Within 28 days of first dose
Phase 1: Objective response rate (ORR)
Prazo: At end of treatment (up to approximately 32 months)

The ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR).
At end of treatment (up to approximately 32 months)
Phase 2a: Duration of response (DoR)
Prazo: From randomisation to end of treatment (up to approximately 32 months)

Defined as the percentage of participants with BOR of CR or PR, as determined by investigator per RECIST version 1.1
From randomisation to end of treatment (up to approximately 32 months)
Phase 2a: Progression-free survival (PFS)
Prazo: From randomisation to end of treatment (up to approximately 32 months)

PFS is defined as the time from the date of randomisation to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1.
From randomisation to end of treatment (up to approximately 32 months)
Phase 2a: Disease control rate (DCR)
Prazo: At end of treatment (up to approximately 32 months)

DCR is defined as the percentage of participants with BOR of CR, PR or stable disease (SD), as determined by investigator per RECIST version 1.1.
At end of treatment (up to approximately 32 months)

Colaboradores e Investigadores

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

Patrocinador

Ipsen

Investigadores

  • Diretor de estudo: Ipsen Medical Director, Ipsen

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)

3 de abril de 2024

Conclusão Primária (Estimado)

20 de março de 2028

Conclusão do estudo (Estimado)

20 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

27 de fevereiro de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de março de 2024

Primeira postagem (Real)

12 de março de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CLIN-01194-450
  • 2023-506228-10-00 (Outro identificador: Ipsen)
  • 2023 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Prazo de Compartilhamento de IPD

Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.

Critérios de acesso de compartilhamento IPD

Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

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 .

Se inscrever