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Seguridad y eficacia de MK-1200 en participantes con tumores sólidos avanzados

11 de mayo de 2026 actualizado por: Merck Sharp & Dohme LLC

Un estudio abierto de fase 1/2 para evaluar la seguridad y eficacia de MK-1200 en participantes con tumores sólidos avanzados

El propósito de este estudio es evaluar la eficacia y seguridad de la monoterapia MK-1200 en participantes con cáncer avanzado/metastásico de la unión gástrica/gastroesofágica (GEJ), cáncer de esófago, cáncer de vías biliares y adenocarcinoma ductal pancreático que han recibido o han sido intolerantes a, todos los tratamientos que se sabe que confieren beneficios clínicos. La parte 1 del estudio será un aumento de dosis para determinar la dosis máxima tolerada (MTD). La parte 2 evaluará la seguridad y eficacia de MK-1200 en 2 dosis diferentes

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

13

Fase

  • Fase 2
  • 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

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital ( Site 0103)
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Bradfordhill-Clinical Area ( Site 0301)
  • Corea del Sur
      • Seoul, Corea del Sur, 06351
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 1003)
  • Estados Unidos
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40202
        • The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
    • Michigan
      • Grand Rapids, Michigan, Estados Unidos, 49546
        • START Midwest ( Site 0014)
    • Texas
      • San Antonio, Texas, Estados Unidos, 78229
        • South Texas Accelerated Research Therapeutics (START) ( Site 0005)
    • Utah
      • West Valley City, Utah, Estados Unidos, 84119
        • START Mountain Region ( Site 0015)
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
        • University of Virginia Health System-Hematology-Oncology ( Site 0009)
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus-Oncology Division ( Site 0602)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center ( Site 0604)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center-Oncology ( Site 0603)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center ( Site 0605)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center ( Site 0601)
  • Porcelana
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100142
        • Beijing Cancer hospital-Digestive Oncology ( Site 0401)
    • Fujian
      • Fuzhou, Fujian, Porcelana, 350000
        • Fujian Cancer Hospital-oncology department ( Site 0409)
    • Jiangsu
      • Huai'an, Jiangsu, Porcelana, 223300
        • First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0415)

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

Criterios de inclusión:

  • Tumor sólido avanzado (irresecable y/o metastásico) confirmado: cáncer gástrico (incluido el cáncer de la unión gastroesofágica), cáncer de esófago, cáncer de las vías biliares o adenocarcinoma ductal pancreático
  • Los participantes que experimentaron eventos adversos (EA) debido a terapias anticancerígenas previas deben haberse recuperado a < Grado 1 o al valor inicial.
  • Los participantes infectados por el virus de la inmunodeficiencia humana (VIH) deben tener el VIH bien controlado y recibir terapia antirretroviral.
  • Los participantes positivos al antígeno de superficie de la hepatitis B (HBsAg) son elegibles si han recibido terapia antiviral contra el virus de la hepatitis B (VHB) durante al menos 4 semanas y tienen una carga viral del VHB indetectable.
  • Los participantes con antecedentes de infección por el virus de la hepatitis C (VHC) son elegibles si la carga viral del VHC es indetectable.
  • Recibido y progresado en o después de 1 o 2 líneas de terapia anteriores

Criterio de exclusión:

  • Enfermedad digestiva severa activa
  • Historia de las principales enfermedades cardiovasculares.
  • Historia de infarto agudo de miocardio; angina inestable; accidente cerebrovascular o ataque isquémico transitorio dentro de los 6 meses anteriores a la primera dosis de la intervención del estudio
  • Uso de marcapasos cardíaco
  • Diabetes o hipertensión que no se pueden controlar con medicamentos.
  • Participantes infectados por VIH con antecedentes de sarcoma de Kaposi y/o enfermedad de Castleman multicéntrica
  • Recibió terapia anticancerígena sistémica previa, incluidos agentes en investigación, dentro de las 4 semanas anteriores a la intervención del estudio.
  • Recibió radioterapia previa dentro de las 2 semanas posteriores al inicio de la intervención del estudio, o tiene toxicidades relacionadas con la radiación que requieren corticosteroides.
  • Neoplasia maligna adicional conocida que está progresando o que ha requerido tratamiento activo en los últimos 2 años
  • Metástasis activas conocidas en el sistema nervioso central (SNC) y/o meningitis carcinomatosa
  • Infección activa que requiere terapia sistémica.
  • No se ha recuperado adecuadamente de una cirugía mayor o tiene complicaciones quirúrgicas continuas.

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 paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Parte 1: MK-1200
En la Parte 1, los participantes recibirán dosis crecientes de MK-1200 mediante infusión intravenosa (IV) cada 2 semanas (Q2W) hasta que se cumplan los criterios de interrupción.
Biológico: MK-1200
Infusión intravenosa
Droga: Antiemético
Uno o más antieméticos profilácticos (p. ej. Los antagonistas del receptor 5-HT3, dexametasona, antagonistas del receptor de neuroquinina-1, etc.) pueden seleccionarse en función de la respuesta previa de los participantes a los medicamentos antieméticos y factores individuales, y se administrarán según la etiqueta del producto aprobado antes de la infusión de MK-1200.
Experimental: Part 2: MK-1200 Cohort A
In Part 2, participants in Cohort A will receive either Dose 1 or Dose 2 of MK-1200 (determined from Part 1) via IV infusion Q2W until any discontinuation criteria are met.
Biológico: MK-1200
Infusión intravenosa
Droga: Antiemético
Uno o más antieméticos profilácticos (p. ej. Los antagonistas del receptor 5-HT3, dexametasona, antagonistas del receptor de neuroquinina-1, etc.) pueden seleccionarse en función de la respuesta previa de los participantes a los medicamentos antieméticos y factores individuales, y se administrarán según la etiqueta del producto aprobado antes de la infusión de MK-1200.
Experimental: Part 2: MK-1200 Cohort B
In Part 2, participants in Cohort B will receive Dose 1 of MK-1200 (determined from Part 1) via IV infusion Q2W until any discontinuation criteria are met.
Biológico: MK-1200
Infusión intravenosa
Droga: Antiemético
Uno o más antieméticos profilácticos (p. ej. Los antagonistas del receptor 5-HT3, dexametasona, antagonistas del receptor de neuroquinina-1, etc.) pueden seleccionarse en función de la respuesta previa de los participantes a los medicamentos antieméticos y factores individuales, y se administrarán según la etiqueta del producto aprobado antes de la infusión de MK-1200.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Part 1
Periodo de tiempo: During the first two 14-day cycles (Up to approximately 28 days)

The occurrence of any of the following toxicities within 28 days after the first dose of study intervention were considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration:

  • Grade 4 nonhematologic toxicity (not laboratory). Any nonhematologic AE ≥Grade 3 in severity was considered a DLT, with pre-specified exceptions
  • Any Grade 3 or Grade 4 laboratory value (hematologic or nonhematologic), with pre-specified exceptions
  • Febrile neutropenia Grade 3 or Grade 4 as prespecified by the protocol
  • Prolonged delay (>2 weeks) in initiating Cycle 2 due to intervention-related toxicity
  • Any intervention-related toxicity that caused the participant to discontinue intervention during Cycle 1
  • Missed >25% of MK-1200 doses as a result of drug-related AEs during the first cycle
  • Grade 5 toxicity
During the first two 14-day cycles (Up to approximately 28 days)
Number of Participants Who Experience One or More Adverse Events (AEs) - Part 1 & Part 2
Periodo de tiempo: Up to approximately 12 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE is reported for each arm.
Up to approximately 12 months
Number of Participants Who Discontinue Study Intervention Due to an AE - Part 1 & Part 2
Periodo de tiempo: Up to approximately 9 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study intervention due to an AE is reported for each arm.
Up to approximately 9 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) - Part 2 Cohort A
Periodo de tiempo: Up to approximately 13 months
ORR was defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by blinded independent central review (BICR). As pre-specified by the protocol, this analysis was to only include all participants randomized to Part 2 Cohort A who received at least 1 dose of study intervention.
Up to approximately 13 months
ORR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Periodo de tiempo: Up to approximately 13 months
ORR was defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator.
Up to approximately 13 months
Area Under the Concentration Versus Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-1200-Antibody-Drug Conjugate (ADC) - Parts 1 and 2
Periodo de tiempo: Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
AUC0-336 was defined as the area under the concentration versus time curve of MK-1200-ADC from time 0 to 336 Hours. Blood samples were collected at pre-specified timepoints to determine the AUC0-336 of the MK-1200-ADC.
Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
AUC0-336 of the Conjugated Toxin Payload (KL610023) - Parts 1 and 2
Periodo de tiempo: Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
AUC0-336 was defined as the area under the concentration versus time curve of KL610023 from time 0 to 336 Hours. Blood samples were collected at pre-specified timepoints to determine AUC0-336 of KL610023.
Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of MK-1200-ADC - Parts 1 and 2
Periodo de tiempo: Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
AUC0-tau was defined as the area under the concentration versus time curve of MK-1200-ADC from time 0 to the end of the 14-day dosing period (Cycle 4, 336 hours post-dose). Blood samples were collected at pre-specified timepoints to determine AUC0-tau of the MK-1200-ADC.
Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
AUC0-tau of KL610023 - Parts 1 and 2
Periodo de tiempo: Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
AUC0-tau is defined as the area under the concentration versus time curve of KL610023 from time 0 to the end of the 14-day dosing period (Cycle 4, 336 hours post-dose). Blood samples were collected at pre-specified timepoints to determine AUC0-tau of KL610023.
Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
Minimum Concentration (Cmin) of MK-1200-ADC - Part 1 & Part 2
Periodo de tiempo: Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
Cmin was defined as the minimum concentration of MK-1200-ADC observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples were collected at pre-specified timepoints to determine Cmin of the MK-1200-ADC.
Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
Cmin of KL610023 - Part 1 & Part 2
Periodo de tiempo: Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
Cmin was defined as the minimum concentration of KL610023 observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples were collected at pre-specified timepoints to determine Cmin of KL610023.
Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
Maximum Concentration (Cmax) of MK-1200-ADC - Part 1 & Part 2
Periodo de tiempo: Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
Cmax was defined as the maximum or 'peak' concentration of MK-1200-ADC observed after its administration. Blood samples were collected at pre-specified timepoints to determine Cmax of the MK-1200-ADC.
Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
Cmax of KL610023 - Part 1 & Part 2
Periodo de tiempo: Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
Cmax was defined as the maximum or 'peak' concentration of KL610023 observed after its administration. Blood samples were collected at pre-specified timepoints to determine Cmax of KL610023.
Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A
Periodo de tiempo: Up to approximately 13 months
For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from the first documented evidence of a CR or a PR until Progressive Disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. As pre-specified by the protocol, DOR for Part 2 Cohort A was planned to be assessed by BICR and was to include all participants randomized to Part 2 Cohort A who received at least one dose of study intervention.
Up to approximately 13 months
DOR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Periodo de tiempo: Up to approximately 13 months
For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from the first documented evidence of a CR or a PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by the investigator is reported.
Up to approximately 13 months
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A
Periodo de tiempo: Up to approximately 13 months
PFS was defined as the time from randomization to the first documented PD by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. As pre-specified by the protocol, PFS for Part 2 Cohort A was planned to be assessed by BICR and was to only include all participants randomized to Part 2 Cohort A who received at least one dose of study intervention.
Up to approximately 13 months
PFS Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Periodo de tiempo: Up to approximately 13 months
PFS was defined as the time from randomization to the first documented PD by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by the investigator is reported.
Up to approximately 13 months
Overall Survival (OS) - Part 1 & Part 2
Periodo de tiempo: Up to approximately 13 months
OS was defined as the time from randomization to death due to any cause.
Up to approximately 13 months

Colaboradores e Investigadores

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

Patrocinador

Merck Sharp & Dohme LLC

Investigadores

  • Director de estudio: Medical Director, Merck Sharp & Dohme LLC

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.

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)

28 de febrero de 2024

Finalización primaria (Actual)

17 de junio de 2025

Finalización del estudio (Actual)

17 de junio de 2025

Fechas de registro del estudio

Enviado por primera vez

26 de enero de 2024

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2024

Publicado por primera vez (Actual)

5 de febrero de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de junio de 2026

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

11 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1200-002
  • U1111-1298-7820 (Identificador de registro: UTN)
  • MK-1200-002 (Otro identificador: MSD)
  • 2023-508684-68-00 (Identificador de registro: EU CT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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

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. .

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