A Phase I Study of JSKN021 in Advanced Solid Tumors
24 de agosto de 2026 actualizado por: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors
This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
199
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: Jian Zhang, MD
- Número de teléfono: 08602134778299
- Correo electrónico: syner2000@163.com
Ubicaciones de estudio
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Fujian
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Fuzhou, Fujian, Porcelana, 350014
- Reclutamiento
- Fujian Cancer Hospital
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Guangxi
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Nanning, Guangxi, Porcelana
- Reclutamiento
- Tumor Hospital of Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150081
- Reclutamiento
- Harbin Medical University Cancer Hospital
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Hubei
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Wuhan, Hubei, Porcelana
- Reclutamiento
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Wuhan, Hubei, Porcelana, 430079
- Reclutamiento
- Hubei Cancer Hospital
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Jiangsu
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Nanjing, Jiangsu, Porcelana
- Reclutamiento
- Jiangsu Province Hospital
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Xuzhou, Jiangsu, Porcelana
- Reclutamiento
- Xuzhou Central Hospital
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Shandong
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Jining, Shandong, Porcelana
- Reclutamiento
- Affiliated Hospital of Jining Medical College
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana
- Reclutamiento
- Fudan University Shanghai Cancer Center
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300060
- Reclutamiento
- Tianjin Medical University Cancer Institute & Hospital
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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:
- Voluntarily participate and sign the informed consent form.
- Age ≥ 18 years old, male or female.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- Expected survival ≥ 3 months.
- Histologically or cytologically confirmed malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.
- At least one measurable lesion at baseline according to RECIST 1.1 criteria.
- Adequate organ function.
- Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
- Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
- Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
- Adequate washout period of previous therapy before the first dose.
Exclusion Criteria:
- Complicated with other malignant tumors within 3 years before the first dose.
- History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
- Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.
- Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
- Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
- Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- Uncontrolled infection.
- Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
- Toxicity of previous anti-tumor treatment has not fully or partially recovered.
- Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
- Pregnant and/or lactating women, or planning to become pregnant during the study period.
- Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.
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: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cohorte de escalada de dosis 2
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JSKN021 administered intravenously at selected dose levels according to protocol
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Experimental: Cohorte de escalada de dosis 3
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JSKN021 administered intravenously at selected dose levels according to protocol
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Experimental: Cohorte 4 de escalada de dosis
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JSKN021 administered intravenously at selected dose levels according to protocol
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Experimental: Cohorte 5 de escalada de dosis
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JSKN021 administered intravenously at selected dose levels according to protocol
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Experimental: Cohorte de escalada de dosis 6
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JSKN021 administered intravenously at selected dose levels according to protocol
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Experimental: Dose escalation cohort 1
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JSKN021 administered intravenously at selected dose levels according to protocol
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Experimental: Dose optimization cohort 1
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JSKN021 administered intravenously at selected dose levels according to protocol
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Experimental: Dose optimization cohort 2
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JSKN021 administered intravenously at selected dose levels according to protocol
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN021)
Periodo de tiempo: From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
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Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc.; abnormalities in physical examinations, laboratory tests, electrocardiograms, and other safety measures.
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From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
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Dose-limiting toxicity (DLT)
Periodo de tiempo: 21 days from the first dose
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Incidence of dose-limiting toxicity (DLT) in each dose group.
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21 days from the first dose
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Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021.
Periodo de tiempo: Up to 24 months
|
Based on safety and efficacy data.
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Up to 24 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective response rate (ORR)
Periodo de tiempo: Up to 24months
|
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1）
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Up to 24months
|
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Duration of response (DoR)
Periodo de tiempo: Up to 24months
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Duration of response (DoR) assessed according to RECIST v1.1.
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Up to 24months
|
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Disease control rate (DCR)
Periodo de tiempo: Up to 24months
|
Disease control rate (DCR) assessed according to RECIST v1.1.
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Up to 24months
|
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Progression-Free Survival (PFS)
Periodo de tiempo: Up to 24months
|
Progression-free survival (PFS) is defined as the time from the date of initial administration till the first documentation of disease progression or death due to any cause (whichever occurs first).
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Up to 24months
|
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Overall survival(OS)
Periodo de tiempo: Up to 24months
|
Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause.
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Up to 24months
|
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Immunogenicity
Periodo de tiempo: Up to 24months
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Incidence and titer changes of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs, if applicable)
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Up to 24months
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Maximum concentration (Cmax) of JSKN021
Periodo de tiempo: Up to 24months
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Maximum concentration (Cmax) of JSKN021
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Up to 24months
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Time to maximum concentration (Tmax) of JSKN021
Periodo de tiempo: Up to 24 months.
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Time to maximum concentration (Tmax) of JSKN021
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Up to 24 months.
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Trough concentration (Ctrough) of JSKN021
Periodo de tiempo: Up to 24 months
|
Trough concentration (Ctrough) of JSKN021
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Up to 24 months
|
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Area under the concentration-time curve of JSKN021
Periodo de tiempo: Up to 24 months
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Area under the concentration-time curve of JSKN021
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Up to 24 months
|
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Volume of distribution (V) of JSKN021
Periodo de tiempo: Up to 24 months
|
Volume of distribution (V) of JSKN021
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Up to 24 months
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Elimination half-life (t1/2) of JSKN021
Periodo de tiempo: Up to 24 months
|
Elimination half-life (t1/2) of JSKN021
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Up to 24 months
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Clearance (CL) of JSKN021
Periodo de tiempo: Up to 24 months
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Clearance (CL) of JSKN021
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Up to 24 months
|
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)
2 de junio de 2026
Finalización primaria (Estimado)
31 de octubre de 2028
Finalización del estudio (Estimado)
31 de mayo de 2029
Fechas de registro del estudio
Enviado por primera vez
20 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
No individual participant data will be shared.
The informed consent form does not include provisions for sharing de-identified participant-level data with researchers outside the study team.
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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