A Phase I Trial of GW01-200 Tablets in Subjects With Advanced Tumors (GW01-200-01)
12 de agosto de 2026 actualizado por: Groovy Medicine (Hangzhou) Ltd.
A First-in-Human Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GW01-200 Tablets in Subjects With Advanced Tumors
A phase 1, open-label, first-in-human study mainly aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GW01-200 tablets in participants with advanced tumors, including solid tumors and hematological malignancies.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yongchao Li
- Número de teléfono: 86-13336882732
- Correo electrónico: liyongchao@groovymedicine.com
Ubicaciones de estudio
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Porcelana, 100142
- Reclutamiento
- Peking University Cancer Hospital
-
Contacto:
- Zhi-Hao Lu, M.D.
- Número de teléfono: 86-13810549767
- Correo electrónico: 13810549767@126.com
-
Investigador principal:
- Zhi-Hao Lu, M.D.
-
-
Heibei
-
Langfang, Heibei, Porcelana, 065000
- Reclutamiento
- Hebei Cancer Hospital of Chinese Academy of Medical Sciences
-
Contacto:
- Yong-Kun Sun, M.D.
- Número de teléfono: 86-131 4127 6041
- Correo electrónico: hsunyk@cicams.ac.cn
-
-
Zhejiang
-
Hangzhou, Zhejiang, Porcelana, 310022
- Reclutamiento
- Zhejiang Cancer Hospital
-
Contacto:
- Zheng-Bo Song, M.D.
- Número de teléfono: 86-13857153345
- Correo electrónico: songzb@zjcc.org.cn
-
Investigador principal:
- Zheng-Bo Song, M.D.
-
-
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:
- Documented locally advanced or metastatic solid tumors or advanced hematological malignancies, with disease progression after standard treatment, or intolerant to standard treatment, or no standard treatment is available.
- Have at least one measurable target lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Minimum life expectancy ≥ 3 months.
- Adequate organ and marrow function.
Exclusion Criteria:
- Participants with a known hypersensitivity to the investigational product(s) or any of the excipients of the product(s).
- History of other primary malignancies, except for those who have been curatively treated and have no known active disease within 5 years prior to the first dose with a very low potential for recurrence, or adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid cancer with no evidence of disease.
- Presence of primary central nervous system (CNS) tumors or symptomatic brain metastases; prior or current leptomeningeal disease or spinal cord compression.
- Radiographic evidence of tumor invasion into major blood vessels (tumor completely approaching, surrounding, or invading the lumen of major blood vessels such as the pulmonary artery or superior vena cava) or evidence of tumor thrombus.
- Received systemic anti-tumor therapy within 28 days prior to the first dose, including chemotherapy, targeted therapy, anti-angiogenic drugs, biological therapy, immunotherapy, radiotherapy, etc., or received traditional Chinese medicine or herbal medicines with clear anti-tumor effects within 1 week prior to the first dose.
- Treatment with medications that may affect the metabolism of the investigational drug within 14 days prior to the first dose, such as strong CYP3A inhibitors, strong CYP3A inducers, or P-gp inhibitors.
- Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of the investigational drug.
- Known to have active infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis.
- Known history of infection with human immunodeficiency virus (HIV).
- Active gastrointestinal disease or other condition that will interfere significantly with the swallowing, absorption, distribution, metabolism, or excretion of oral therapy.
- For female subjects: currently pregnant or lactating.
- Presence of clinically significant severe ophthalmic examination abnormalities at screening, such as retinitis pigmentosa, maculopathy, active ocular infection, etc., or known history of retinal or optic nerve disorders, such as retinitis pigmentosa, maculopathy, glaucoma, optic neuritis, etc.
- Participants with a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or a history of melena or hematemesis within 2 months before dosing, or those who may experience visceral hemorrhage as determined by the investigator.
- Clinically symptomatic moderate to severe ascites or pleural effusion, or presence of uncontrolled or moderate to severe pericardial effusion.
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: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Ia-Part A
Participants with advanced solid tumors will receive GW01-200 tablets orally at ascending dose levels.
|
GW01-200 tablets will be administered orally.
|
|
Experimental: Ia-Part B
Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets orally at ascending dose levels.
|
GW01-200 tablets will be administered orally.
|
|
Experimental: Ib-Part C
Participants with advanced solid tumors will receive GW01-200 tablets at the specified dose.
|
GW01-200 tablets will be administered orally.
|
|
Experimental: Ib-Part D
Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets at the specified dose.
|
GW01-200 tablets will be administered orally.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of participants with adverse events (AEs) and serious AEs (SAEs)
Periodo de tiempo: Up to approximately 2 years
|
To assess the safety and tolerability of GW01-200 tablets.
|
Up to approximately 2 years
|
|
Parts A and B: The recommended dose(s) for expansion (RDEs) of GW01-200 tablets
Periodo de tiempo: At the end of Cycle 1 (each cycle is 28 days)
|
Number of participants with dose-limiting toxicities (DLTs)
|
At the end of Cycle 1 (each cycle is 28 days)
|
|
Parts C and D: The preliminary efficacy of GW01-200 tablets at the RDEs dose.
Periodo de tiempo: Up to approximately 2 years
|
Objective response rate (ORR) assessed by investigator.
|
Up to approximately 2 years
|
|
Parts C and D: The recommended Phase II Dose (RP2D) of GW01-200 tablets
Periodo de tiempo: Up to approximately 2 years
|
The RP2D of GW01-200 tablets will be determined based on the data obtained from Parts C and D.
|
Up to approximately 2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum concentration (Cmax)
Periodo de tiempo: Up to approximately 2 years
|
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
|
Up to approximately 2 years
|
|
Area under the concentration-time curve (AUC)
Periodo de tiempo: Up to approximately 2 years
|
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
|
Up to approximately 2 years
|
|
Time to maximum concentration (Tmax)
Periodo de tiempo: Up to approximately 2 years
|
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
|
Up to approximately 2 years
|
|
Elimination half-life (t1/2)
Periodo de tiempo: Up to approximately 2 years
|
To characterise the pharmacokinetics (PK) of GW01-200 when given orally
|
Up to approximately 2 years
|
|
Parts A and B: The preliminary efficacy of GW01-200 tablets in participants with advanced tumors
Periodo de tiempo: Up to approximately 2 years
|
ORR assessed by investigator.
|
Up to approximately 2 years
|
|
Duration of response (DoR)
Periodo de tiempo: Up to approximately 2 years
|
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
|
Up to approximately 2 years
|
|
Disease control rate (DCR)
Periodo de tiempo: Up to approximately 2 years
|
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
|
Up to approximately 2 years
|
|
Progression-free survival (PFS)
Periodo de tiempo: Up to approximately 2 years
|
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
|
Up to 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 (Actual)
17 de julio de 2026
Finalización primaria (Estimado)
1 de enero de 2029
Finalización del estudio (Estimado)
1 de junio de 2029
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
5 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- GW01-200-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .