- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07567859
A Study of HS-10587 in Patients With Advanced Solid Tumors
28 de abril de 2026 actualizado 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.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
362
Fase
- Fase 1
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Participants who voluntarily participate in this clinical study, understand the study procedures, and are able to sign a written ICF.
- 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.
- Evidence of MTAP deletion in the tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
- 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:
- History of other primary malignancies.
- Presence of pleural/abdominal effusion or pericardial effusion requiring clinical intervention.
- Presence of leptomeningeal metastasis, spinal cord compression, or brainstem metastasis; known untreated brain metastases, or symptomatic/unstable brain metastases.
- 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).
- Inadequate bone marrow reserve or hepatic and renal functions.
- Severe, uncontrolled, or active cardiovascular diseases.
- Severe or poorly controlled diabetes.
- Severe or poorly controlled hypertension.
- Severe infection within 4 weeks prior to the first dose.
- Long-term corticosteroid therapy, history of other acquired/congenital immunodeficiency disorders, or organ transplantation.
- Known active infectious diseases.
- Clinically significant gastrointestinal dysfunction.
- Moderate to severe pulmonary diseases that seriously affect respiratory function.
- Prior history of severe neurological or mental disorders.
- Female participants who are pregnant or breastfeeding, or plan to become pregnant during the study.
- 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.
- Participants with any conditions that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: HS-10587 Monotherapy
Dose escalation cohorts and dose expansion cohorts of varying doses of HS-10587
|
HS-10587 tablet
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of DLT
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
4 de junio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
30 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
20 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de abril de 2026
Publicado por primera vez (Actual)
5 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- HS-10587-101
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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