Phase 1 Study of MST-168 in Participants With Advanced Solid Malignant Tumors
A Phase 1, Multiregional, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MST-168, in Participants With Advanced Solid Malignant Tumors
A Phase 1, multiregional, open-label study of MST-168 in participants with target-driven advanced solid tumors.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy of MST-168 in participants with target-driven advanced solid tumors. MST-168 is an investigational ADC.
Descripción general del estudio
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Changlong Liu
- Número de teléfono: +86-15810213012
- Correo electrónico: changlong.liu@mabsoftbio.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Participants are eligible to be included in the study only if all of the following criteria apply:
I1. Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
I2. Is at least 18 years of age at the time of signing the ICF.
I3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
I4. Life expectancy ≥ 12 weeks.
I5. Has adequate organ function.
I6. Pregnancy and Contraception: Female participants agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment. Male participants with partners of childbearing potential and female participants of childbearing potential are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from beginning of the study screening until 6 months after receiving the last treatment of MST-168.
I7. Has a pathologically documented advanced/unresectable or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Exclusion Criteria:
- Participants are excluded from the study if any of the following criteria apply:
E1. Has untreated brain or CNS metastases or brain/CNS metastases that have progressed [e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases]. Participants with previously unstable brain or CNS metastases.
E2. Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
E3. Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
E4. Has known sensitivity to study intervention components or excipients.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: MST-168 initial dose level treatment Cohort
MST-168 initial dose level
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
Experimental: MST-168 dose level 2 treatment Cohort
MST-168 dose level 2
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
Experimental: MST-168 dose level 3 treatment Cohort
MST-168 dose level 3
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
Experimental: MST-168 dose level 4 treatment Cohort
MST-168 dose level 4
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
Experimental: MST-168 dose level 5 treatment Cohort
MST-168 dose level 5
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
Experimental: MST-168 dose level 6 treatment Cohort
MST-168 dose level 6, if needed
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Incidence of dose-limiting toxicities (DLT)
Periodo de tiempo: Day 1 - Day 28
|
Day 1 - Day 28
|
|
Incidence and severity of AEs, clinically significant changes from Baseline (pre-dose on D1) through to the EOT in vital signs, laboratory tests, physical examinations, 12-lead ECG, and ECHO/MUGA.
Periodo de tiempo: Through study completion, up to 25 months
|
Through study completion, up to 25 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Tmax
Periodo de tiempo: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Cmax
Periodo de tiempo: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t
Periodo de tiempo: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞
Periodo de tiempo: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: t1/2
Periodo de tiempo: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: CL
Periodo de tiempo: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Vss
Periodo de tiempo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: AUCss
Periodo de tiempo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Css,max
Periodo de tiempo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Css,min
Periodo de tiempo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Frequencies of ADAs and neutralizing antibodies specific to MST-168.
Periodo de tiempo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Biomarkers: cytokines/chemokines and immune cell phenotypes
Periodo de tiempo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Objective response rate (ORR) based on RECIST v1.1.
Periodo de tiempo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Duration of response (DoR) based on RECIST v1.1.
Periodo de tiempo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Progression-free survival (PFS) based on RECIST v1.1.
Periodo de tiempo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Disease control rate (DCR) based on RECIST v1.1.
Periodo de tiempo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- MST-168-101
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .