Estudio de expansión y aumento de dosis de HM16390 en tumores sólidos avanzados o metastásicos
Un estudio de fase I, abierto, multicéntrico, de aumento y expansión de dosis de HM16390 en pacientes con tumores sólidos avanzados o metastásicos
This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent and in combination with pembrolizumab to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors.
Dose-Escalation Part is planned to establish the MTD or RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation Part, additional eligible subjects will be randomized 1:1 into each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the RDEs to be tested in the Dose-Expansion Part are determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent and in combination with pembrolizumab when administered at the RDEs to subjects in indication-specific expansion cohorts.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hyebin Son
- Número de teléfono: 82-2-410-9835
- Correo electrónico: hyebin.son@hanmi.co.kr
Ubicaciones de estudio
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Seoul, Corea del Sur, 03080
- Reclutamiento
- Seoul National University Hospital
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Seoul, Corea del Sur, 06351
- Reclutamiento
- Samsung Medical Center
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Seoul, Corea del Sur, 03722
- Reclutamiento
- Severance Hospital
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Seoul, Corea del Sur, 05505
- Activo, no reclutando
- Asan Medical Center
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Corea del Sur, 13620
- Reclutamiento
- Seoul National University Bundang Hospital
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California
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Los Angeles, California, Estados Unidos, 90095
- Reclutamiento
- The Regents of the University of California on behalf of its Los Angeles campus
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Reclutamiento
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Reclutamiento
- Karmanos Cancer Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
- Have a histologically and/or cytologically confirmed advanced or metastatic solid tumor and have failed or are intolerant to standard therapy with clinical benefit.
- Patients in the Dose-Escalation Part must have evaluable or measurable disease at baseline and the patients for Dose-Ranging and Dose-Expansion Part must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before allocation or randomization.
- Age of 18 years or older (or country's legal age of majority if the legal age was >18 years)
- Adequate renal function.
- Adequate hematologic function.
- Adequate liver function.
Key Exclusion Criteria:
- Received prior treatment with agent targeting the IL-2, IL-7, or IL-15 receptors, or related to mode of action of HM16390.
- Known active CNS metastases and/or carcinomatous meningitis.
- History of severe toxicities associated with a prior immunotherapy.
- Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per NCI-CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
- Has ongoing or suspected autoimmune disease.
- Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.
- History of chronic liver disease or evidence of hepatic cirrhosis.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: HM16390
HM16390 Monotherapy |
HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle |
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Experimental: HM16390 + pembrolizumab
HM16390 in combination with pembrolizumab |
Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
Otros nombres:
HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence and nature of DLTs
Periodo de tiempo: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
|
To evaluate safety and tolerability of HM16390 as a single agent and in combination with pembrolizumab |
At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
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Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Periodo de tiempo: Throughout the study until end of safety follow-up period (90 days after the last treatment)
|
To evaluate safety and tolerability of HM16390 as a single agent, and in combination with pembrolizumab |
Throughout the study until end of safety follow-up period (90 days after the last treatment)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Objective response rate (ORR)
Periodo de tiempo: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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Disease Control Rate (DCR)
Periodo de tiempo: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
DCR will be measured as the proportion of subject with confirmed CR, PR, or Stable Disease (SD) as per RECIST v1.1 |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
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The maximum serum concentration (Cmax)
Periodo de tiempo: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
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The time to reach Cmax (Tmax)
Periodo de tiempo: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
Periodo de tiempo: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
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The AUC extrapolated to infinity (AUCinf)
Periodo de tiempo: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
The AUC during the dosing interval (AUCtau)
Periodo de tiempo: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
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The serum concentration at the end of the dosing interval (Ctrough)
Periodo de tiempo: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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The elimination half-life (T1/2)
Periodo de tiempo: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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The apparent volume of distribution (Vd/F)
Periodo de tiempo: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
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The apparent clearance (CL/F)
Periodo de tiempo: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
|
Progression-free survival (PFS)
Periodo de tiempo: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v1.1 or until death from any cause, whichever occurs first |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
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Duration of response (DOR)
Periodo de tiempo: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v1.1 or death from any cause, whichever occurs first. |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HM-LIL2-101
- KEYNOTE-G39 (Otro identificador: Merck & Sharp Dohme LLC)
- MK-3475-G39 (Otro identificador: Merck & Sharp Dohme LLC)
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.
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