Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

MSB0011359C (M7824) in Subjects With Metastatic or Locally Advanced Solid Tumors

7 de marzo de 2022 actualizado por: Merck KGaA, Darmstadt, Germany

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0011359C (M7824) in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications in Asia

The main purpose of this study is assess the safety and tolerability of MSB0011359C. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or a standard therapy has failed.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

114

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.

Ubicaciones de estudio

  • Corea, república de
      • Seoul, Corea, república de
        • Seoul National University Hospital
      • Seoul, Corea, república de
        • Asan Medical Center
      • Seoul, Corea, república de
        • Severance Hospital
  • Japón
      • Fukuoka, Japón
        • NHO Kyushu Cancer Center
      • Kashiwa, Japón
        • National Cancer Center East, Department of Experimental Therapeutics
      • Kashiwa, Japón
        • National Cancer Center East, Department of hepatobiliary and pancreatic oncology
      • Kitaadachi-gun, Japón
        • Saitama Cancer Center
      • Matsuyama, Japón
        • NHO Shikoku Cancer Center
      • Nagoya, Japón
        • Aichi Cancer Center Hospital
      • Osakasayama, Japón
        • Kinki University Hospital
      • Tokyo, Japón
        • National Cancer Center, Department of Experimental Therapeutics
      • Tokyo, Japón
        • National Cancer Center, Department of hepatobiliary and pancreatic oncology
      • Yokohama, Japón
        • Kanagawa Cancer Center, Department of Gastroenterology
      • Yokohama, Japón
        • Kanagawa Cancer Center, Department of Gastrointestinal Surgery
  • Taiwán
      • Tainan, Taiwán
        • National Cheng Kung University Hospital
      • Taipei, Taiwán
        • Mackay Memorial Hospital
      • Taipei, Taiwán
        • National Taiwan University Hospital
      • Taoyuan, Taiwán
        • Chang Gung Memorial Hospital; Linkou

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

20 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Able and willing to give written informed consent and has signed the appropriate written informed consent form (ICF), prior to performance of any trial activities
  • Eligible male and female subjects aged greater than or equal to (>=)20 years
  • Histologically or cytologically proven metastatic or locally advanced solid tumors, for which no effective standard therapy exists or standard therapy has failed
  • Eastern Cooperative Oncology Group performance status (ECOG) performance status of 0 to 1 at trial entry
  • Life expectancy >=12 weeks as judged by the Investigator.
  • Adequate hematological function defined by white blood cell (WBC) count >=3*10^9/Liter with absolute neutrophil count (ANC) >=1.5*10^9/Liter, lymphocyte count >=0.5* 10^9/Liter, platelet count >=75*10^9/Liter, and Hemoglobin (Hgb) >= 9 grams per deciliter (g/dL) (in absence of blood transfusion).
  • Adequate hepatic function defined by a total bilirubin level <=1.5 × Upper limit of normal (ULN), an AST level <= 2.5 × ULN, and an ALT level <= 2.5 × ULN.
  • Adequate renal function defined by an estimated creatinine clearance >50 milliliter per minute (mL/min) according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24 hour urine collection.

Other protocol-defined exclusion criteria could apply.

Exclusion Criteria:

  • Concurrent treatment with non-permitted drugs and other interventions
  • Anticancer treatment within 28 days before the start of trial treatment, for example cyto reductive therapy, radiotherapy (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy
  • Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy)
  • Systemic therapy with immunosuppressive agents within 7 days before the start of trial treatment; or use of any investigational drug within 28 days before the start of trial treatment
  • Previous malignant disease other than the target malignancy to be investigated in this trial with the exception of cervical carcinoma in situ and superficial or non invasive bladder cancer (treated with curative intent) within the last 5 years or basal cell or squamous cell carcinoma in situ within the last 3 years
  • Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures
  • Active or history of central nervous system metastases, except as in the melanoma-specific Central nervous system (CNS) criteria listed above
  • Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (eg, corneal transplant, hair transplant)

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: MSB0011359C (M7824)
Droga: MSB0011359C
Subjects with metastatic or locally advanced solid tumors will receive intravenous infusion of MSB0011359C over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
Otros nombres:
  • M7824

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of subjects with DLT (Dose limiting Toxicity): dose escalation part
Periodo de tiempo: Baseline up to Week 3
A DLT is defined as any grade greater than or equal to (>=) 3 adverse event suspected to be related to investigational medicinal product (IMP) by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment.
Baseline up to Week 3
Number of Subjects with treatment-emergent adverse events (TEAEs)
Periodo de tiempo: First trial drug administration up to 30 days after the last drug administration assessed up to 2 years
An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. AEs (SAEs and non-SAEs) will be considered TEAEs when emerging on treatment period defined as the time from the first trial drug administration up to 30 days after the last drug administration date or the earliest date of subsequent anticancer drug therapy minus 1 day, whichever occurs first, unless otherwise stated.
First trial drug administration up to 30 days after the last drug administration assessed up to 2 years
Number of subjects with treatment-related Adverse Events (AE)
Periodo de tiempo: First trial drug administration up to 30 days after the last drug administration assessed up to 2 years
Treatment related AEs are any untoward medical occurrence in a subject who received study drug with causal relationship with the investigational product as assessed by the investigator.
First trial drug administration up to 30 days after the last drug administration assessed up to 2 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Maximum serum concentration (Cmax) of MSB0011359C
Periodo de tiempo: Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Minimum serum concentration (Cmin) of MSB0011359C
Periodo de tiempo: Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Area under the concentration time curve from zero to last sampling time (AUC0-t) of MSB0011359C
Periodo de tiempo: Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Area under the concentration time curve from time zero to infinity (AUC0-inf) of MSB0011359C
Periodo de tiempo: Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Terminal half life (t1/2) of MSB0011359C
Periodo de tiempo: Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Serum titers of anti-MSB0011359C antibodies
Periodo de tiempo: Predose, Day 15, 43, 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to 3 years
Predose, Day 15, 43, 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to 3 years
Best Overall Response (BOR) as assessed by investigator: Dose escalation part
Periodo de tiempo: Date of randomization up to 2 years
BOR will be assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. BOR is defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD.
Date of randomization up to 2 years
Best Overall Response (BOR) as assessed by investigator: Expansion part
Periodo de tiempo: Date of randomization up to 2 years
BOR will be assessed by investigator according to RECIST Version 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Date of randomization up to 2 years
Best Overall Response (BOR) as assessed by Independent Endpoint Review Committee (IRC): Expansion part
Periodo de tiempo: Date of randomization up to 2 years
The BOR per Independent Endpoint Review Committee (IRC) adjudication will be determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Date of randomization up to 2 years
Duration of response
Periodo de tiempo: Date of randomization up to 2 years
Time from first assessment of CR to disease progression or death, for TLs, CR was defined as the disappearance of all TLs
Date of randomization up to 2 years
Disease control rate
Periodo de tiempo: Date of randomization up to 2 years
The disease control rate is defined as the percentage of subjects with BOR. The BOR per IRC adjudication will be determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Date of randomization up to 2 years
Progression Free survival (PFS) time
Periodo de tiempo: Date of randomization until death or progressive disease assessed up to 2 years
PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS will be assessed as RECIST v1.1 as adjudicated by IRC. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Date of randomization until death or progressive disease assessed up to 2 years
Overall Survival (OS) time
Periodo de tiempo: Date of randomization until death assessed up to 2 years
OS is defined as the time from randomization to death due to any cause.
Date of randomization until death assessed up to 2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Merck KGaA, Darmstadt, Germany

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

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)

11 de marzo de 2016

Finalización primaria (Actual)

21 de febrero de 2022

Finalización del estudio (Actual)

21 de febrero de 2022

Fechas de registro del estudio

Enviado por primera vez

1 de marzo de 2016

Primero enviado que cumplió con los criterios de control de calidad

3 de marzo de 2016

Publicado por primera vez (Estimar)

4 de marzo de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de marzo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

7 de marzo de 2022

Última verificación

1 de marzo de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 200647-0008

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. .

Ensayos clínicos sobre Tumores sólidos

Ensayos clínicos sobre MSB0011359C

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Argentina

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir