A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy
A Randomized, Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of YL201 Versus Liposomal Irinotecan in Combination With 5-Fluorouracil/Leucovorin in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed Prior Gemcitabine-based Systemic Therapy
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: MediLink Study Team
- Número de teléfono: +86 512 62858368
- Correo electrónico: clinicaltrials@medilinkthera.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200127
- Shanghai Jiaotong University School of Medicine
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Contacto:
- Study Coordinator
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Participants must voluntarily sign a written informed consent form (ICF) and be willing and able to comply with protocol requirements.
- Participants must be ≥18 and ≤75 years of age.
- Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Participants must have a life expectancy of at least 3 months.
- Participants must have histologically or cytologically confirmed incurable metastatic pancreatic ductal adenocarcinoma (PDAC).
- Participants must have received and failed only one prior line of gemcitabine-based systemic therapy.
- Participants must have at least one measurable lesion according to RECIST v1.1.
- Participants must have adequate organ function as defined in the protocol.
- Participants must agree to follow the contraception requirements specified in the protocol.
Exclusion Criteria:
- Participants with another malignancy within 5 years before randomization.
- Participants with pathologically confirmed pancreatic cancer other than PDAC.
- Participants who have previously received B7-H3-targeted therapy.
- Participants who have previously received topoisomerase I inhibitor or antibody-drug conjugate containing topoisomerase I inhibitor.
- Participants who are concurrently enrolled in another clinical study, unless it is an observational, non-interventional study or the participant is in the follow-up period of an interventional study.
- Participants who have not met the protocol-specified washout requirements for prior systemic therapy, relevant concomitant medications, radiotherapy, or surgery before randomization, or who have not adequately recovered from prior surgery or are planning to undergo major surgery during the study.
- Participants with protocol-specified exclusionary conditions related to central nervous system (CNS) metastases, history of transplantation, immunosuppressive therapy, live vaccine administration, or autoimmune or inflammatory diseases.
- Participants with uncontrolled or clinically significant concomitant diseases, including serious gastrointestinal, cardiovascular or cerebrovascular, pulmonary, thromboembolic, bleeding-related, effusion-related, or ascites-related safety risks.
- Participants with recent serious infection, active infection, active tuberculosis or syphilis, HIV positivity or immunodeficiency, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Participants with unresolved toxicity from prior anticancer therapy that has not recovered to the level specified in the protocol.
- Participants with known hypersensitivity to any component of the study treatment, or a history of severe hypersensitivity reactions or severe infusion-related reactions.
- Participants who are pregnant or breastfeeding, planning to become pregnant or breastfeed, or who have any other medical, psychiatric, social, or compliance-related factors that, in the investigator's opinion, would make them unsuitable for participation in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Tambotatug pelitecan
Tambotatug pelitecan, monotherapy
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Drug: Tambotatug pelitecan 2.0mg/kg (maximum 200mg) Intravenous infusion Every 3 weeks Treatment will continue until disease progression or unacceptable toxicity.
Otros nombres:
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Comparador activo: Chemotherapy
Active comparator: nal-IRI+5-FU/LV
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Liposomal irinotecan Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. 5 Fluorouracil Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. Leucovorin Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PFS by BICR
Periodo de tiempo: Up to approximately 2 years
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Progression-free Survival (PFS) is assessed by Blinded Independent Central Review(BICR) per response evaluation criteria in solid tumors (RECIST) v1.1
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Up to approximately 2 years
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OS
Periodo de tiempo: Up to approximately 2 years
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OS is defined as the time from randomization until death from any cause.
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Up to approximately 2 years
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PFS by investigator
Periodo de tiempo: Up to approximately 2 year
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PFS per RECIST v1.1, as assessed by Investigator
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Up to approximately 2 year
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ORR
Periodo de tiempo: Up to approximately 2 years
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Objective Response Rate (ORR), as assessed by BICR and Investigator
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Up to approximately 2 years
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DCR
Periodo de tiempo: Up to approximately 2 years
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Disease Control Rate (DCR), as assessed by BICR and Investigator
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Up to approximately 2 years
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DoR
Periodo de tiempo: Up to approximately 2 years
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Duration of Response (DoR), as assessed by BICR and Investigator
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Up to approximately 2 years
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TTR
Periodo de tiempo: Up to approximately 2 years
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Time to Response (TTR), as assessed by BICR and Investigator
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Up to approximately 2 years
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Adverse Event
Periodo de tiempo: Up to approximately 2 years
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The incidence and severity of AEs, SAEs and AESIs per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0
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Up to approximately 2 years
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To evaluate the AUC
Periodo de tiempo: Up to approximately 2 years
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Up to approximately 2 years
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To evaluate the Cmax
Periodo de tiempo: Up to approximately 2 years
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Up to approximately 2 years
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To evaluate the Ctrough
Periodo de tiempo: Up to approximately 2 years
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Up to approximately 2 years
|
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To evaluate the CL
Periodo de tiempo: Up to approximately 2 years
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Up to approximately 2 years
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To evaluate the Vd
Periodo de tiempo: Up to approximately 2 years
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Up to approximately 2 years
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To evaluate the t1/2
Periodo de tiempo: Up to approximately 2 years
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Up to approximately 2 years
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Immunogenicity
Periodo de tiempo: Up to approximately 2 years
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Incidence of anti-drug antibodies of YL201
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Up to approximately 2 years
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Neoplasias por sitio
- Neoplasias
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Neoplasias pancreáticas
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Enzimas y coenzimas
- Pirimidinas
- Formiltetrahidrofolatos
- Tetrahidrofolatos
- Ácido fólico
- Pterins
- Pteridinas
- Uracílico
- Pirimidinonas
- Coenzimas
- Fluorouracilo
- Leucovorina
- Sucrosofado de Irinotecan
Otros números de identificación del estudio
Otros números de identificación del estudio
- TAISHAN-305
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.
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