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A Study of HS-10587 in Patients With Advanced Solid Tumors

28 de abril de 2026 atualizado por: Jiangsu Hansoh Pharmaceutical Co., Ltd.

An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Preliminary Efficacy of HS-10587 in Patients With Methylthioadenosine Phosphorylase (MTAP)-Deleted Advanced Solid Tumors

This is a Phase I, multicenter, open-label clinical trial with dose escalation/dose expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HS-10587 in patients with MTAP-deleted advanced solid tumors.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

362

Estágio

  • Fase 1

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:

  1. Participants who voluntarily participate in this clinical study, understand the study procedures, and are able to sign a written ICF.
  2. Participants with locally advanced or recurrent metastatic malignant solid tumors confirmed by histopathology or cytopathology who have failed or are intolerant to at least one line of prior standard treatment, or for whom no standard treatment exists.
  3. Evidence of MTAP deletion in the tumor tissue.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Life expectancy ≥12 weeks.
  6. At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
  7. Female participants of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed; male participants are willing to use barrier contraception.

Exclusion Criteria:

  1. History of other primary malignancies.
  2. Presence of pleural/abdominal effusion or pericardial effusion requiring clinical intervention.
  3. Presence of leptomeningeal metastasis, spinal cord compression, or brainstem metastasis; known untreated brain metastases, or symptomatic/unstable brain metastases.
  4. Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior anti-tumor therapies (except alopecia, pigmentation, and residual neurotoxicity).
  5. Inadequate bone marrow reserve or hepatic and renal functions.
  6. Severe, uncontrolled, or active cardiovascular diseases.
  7. Severe or poorly controlled diabetes.
  8. Severe or poorly controlled hypertension.
  9. Severe infection within 4 weeks prior to the first dose.
  10. Long-term corticosteroid therapy, history of other acquired/congenital immunodeficiency disorders, or organ transplantation.
  11. Known active infectious diseases.
  12. Clinically significant gastrointestinal dysfunction.
  13. Moderate to severe pulmonary diseases that seriously affect respiratory function.
  14. Prior history of severe neurological or mental disorders.
  15. Female participants who are pregnant or breastfeeding, or plan to become pregnant during the study.
  16. History of severe allergies, or history of hypersensitivity reactions to any active or inactive ingredients of HS-10587 or to drugs with similar chemical structures to HS-10587 or drugs of the same class as HS-10587.
  17. Participants with any conditions that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.

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: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: HS-10587 Monotherapy
Dose escalation cohorts and dose expansion cohorts of varying doses of HS-10587
HS-10587 tablet

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence of DLT
Prazo: Up to 21 days after the first administration. (first cycle)
dose-limiting toxicities
Up to 21 days after the first administration. (first cycle)
MTD or MAD
Prazo: Up to 21 days after the first administration. (first cycle)
maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Up to 21 days after the first administration. (first cycle)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Prazo: From time of informed consent to 28 days post last dose of HS-10587.
Number of participants with AEs and SAEs
From time of informed consent to 28 days post last dose of HS-10587.
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
Prazo: Predose and postdose up to end of treatment, approximately 2 years
Maximum concentration (Cmax).
Predose and postdose up to end of treatment, approximately 2 years
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
Prazo: Predose and postdose up to end of treatment, approximately 2 years.
Time of maximum concentration (Tmax).
Predose and postdose up to end of treatment, approximately 2 years.
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
Prazo: Predose and postdose up to end of treatment, approximately 2 years.
area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration (AUC0-t)
Predose and postdose up to end of treatment, approximately 2 years.
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
Prazo: Predose and postdose up to end of treatment, approximately 2 years
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
Predose and postdose up to end of treatment, approximately 2 years
Efficacy of HS-10587 in patients with advanced solid tumors
Prazo: Predose and post dose up to end of treatment, approximately 2 years
Objective response rate (ORR) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years
Efficacy of HS-10587 in patients with advanced solid tumors.
Prazo: Predose and post dose up to end of treatment, approximately 2 years.
Duration of response (DOR) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years.
Efficacy of HS-10587 in patients with advanced solid tumors.
Prazo: Predose and post dose up to end of treatment, approximately 2 years
Disease control rate (DCR) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years
Efficacy of HS-10587 in patients with advanced solid tumors.
Prazo: Predose and post dose up to end of treatment, approximately 2 years.
Time to response (TTR) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years.
Efficacy of HS-10587 in patients with advanced solid tumors.
Prazo: Predose and post dose up to end of treatment, approximately 2 years.
Progression-free survival (PFS) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years.
Efficacy of HS-10587 in patients with advanced solid tumors.
Prazo: Predose and post dose up to end of treatment, approximately 2 years
Overall survival (OS) evaluated as per RECIST v1.1
Predose and post dose up to end of treatment, approximately 2 years

Colaboradores e Investigadores

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

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)

4 de junho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2027

Conclusão do estudo (Estimado)

30 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

20 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de abril de 2026

Primeira postagem (Real)

5 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HS-10587-101

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

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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