A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.
11 de junio de 2026 actualizado por: Shanghai EpimAb Biotherapeutics Co., Ltd.
A First-in-Human, Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Activity of EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors
The primary purpose of this study is to evaluate safety and tolerability profile of EMB-15, identify the recommended Phase 2 dose(s) (RP2Ds) for EMB-15.
Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and the anti-tumor activity of EMB-15 will also be assessed.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
This is a first-in-human (FIH), open-label, Phase I, multicenter dose escalation study to identify the RP2D and to evaluate the safety, tolerability, pharmacokinetics, and antitumor activities of EMB-15 in adult patients with locally advanced/metastatic solid tumors who have progressed on available standard of care or for which no standard therapy exists.This is an open-label, non-randomized dose-escalation study comprising a dose-escalation phase and a dose-expansion phase.
It's planned to recruit approximately 50 patients (the final number will be determined depending on the number of dose levels) with locally advanced or metastatic solid tumors.
The trial consists of a screening period (Day -28 to Day -1), a step-up dose period (applicable only to doses with higher CRS risk, lasting 7 days or longer), a treatment period (28 days per cycle, up to 2 years), and a safety follow-up period (30 days after the last dose).
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
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.
Estudio Contacto
- Nombre: Xi Yang
- Número de teléfono: 86-21-61951000
- Correo electrónico: xyang@epimab.com
Ubicaciones de estudio
-
-
Guangdong
-
Guangzhou, Guangdong, Porcelana, 510655
- Reclutamiento
- Sixth Affiliated Hospital of Sun Yat-sen University
-
Contacto:
- Mingfei Zhang
- Número de teléfono: 86-21-61951000
- Correo electrónico: mfzhang@epimab.com
-
-
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
Inclusion Criteria:
- 1) Able to understand and willing to sign an ICF 2) Males or females with the age ≥ 18 years 3) Life expectancy > 3 months. 4) ECOG performance status 0 or 1 5) Patients must have histologically or cytologically confirmed locally advanced or metastatic solid tumors, without standard therapy.
6) Patients must provide archived tumor samples collected within 1 year. 7) Adequate hematological and organ function.
Exclusion Criteria:
Patients meeting any of the following criteria will not be enrolled:
- Any prior ALPP/ALPG targeting therapy
- Has received anticancer therapy, radiotherapy, or investigational drug within < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
- Active autoimmune disease or history of autoimmune disease
- Concurrent malignancy < 5 years prior to study entry
- active infection
- Severe or uncontrolled cardiovascular disease requiring treatment
- Other severe medical conditions
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 Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: EMB-15
This is an open-label, non-randomized dose-escalation study comprising a dose-escalation phase and a dose-expansion phase.
It's planned to recruit approximately 50 patients (the final number will be determined depending on the number of dose levels) with locally advanced or metastatic solid tumors.
The trial consists of a screening period (Day -28 to Day -1), a step-up dose period (applicable only to doses with higher CRS risk, lasting 7 days or longer), a treatment period (28 days per cycle, up to 2 years), and a safety follow-up period (30 days after the last dose).
|
EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidencia de eventos adversos graves (SAE)
Periodo de tiempo: Detección hasta seguimiento (30 días después de la última dosis)
|
Incidencia de SAE.
|
Detección hasta seguimiento (30 días después de la última dosis)
|
|
Intensidad de la dosis
Periodo de tiempo: Detección hasta seguimiento (30 días después de la última dosis)
|
Cantidad real de medicamento que toman los pacientes dividida por la cantidad planificada.
|
Detección hasta seguimiento (30 días después de la última dosis)
|
|
incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT.
Periodo de tiempo: Screening up to follow-up (30 days after the last dose)
|
Incidence and severity of AE.
|
Screening up to follow-up (30 days after the last dose)
|
|
Incidence of dose interruptions
Periodo de tiempo: Screening up to follow-up (30 days after the last dose)
|
Incidence of dose interruptions of EMB-15 during treatment as a measure of tolerability.
|
Screening up to follow-up (30 days after the last dose)
|
|
The incidence of DLTs during the DLT evaluation period.
Periodo de tiempo: First infusion to the end of Cycle 1 (each cycle is 28 days)
|
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
|
First infusion to the end of Cycle 1 (each cycle is 28 days)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Area under the serum concentration-time curve (AUC) of EMB-15
Periodo de tiempo: Through treatment until EOT visit, expected average 6 months
|
Blood samples for serum PK analysis will be obtained (AUC).
|
Through treatment until EOT visit, expected average 6 months
|
|
Maximum serum concentration (Cmax) of EMB-15
Periodo de tiempo: Through treatment until EOT visit, expected average 6 months
|
Blood samples for serum PK analysis will be obtained (Cmax)
|
Through treatment until EOT visit, expected average 6 months
|
|
Trough concentration (Ctrough) of EMB-15
Periodo de tiempo: Through treatment until EOT visit, expected average 6 months
|
Blood samples for serum PK analysis will be obtained (Ctrough)
|
Through treatment until EOT visit, expected average 6 months
|
|
Average concentration over a dosing interval (Css, avg)of EMB-15
Periodo de tiempo: Through treatment until EOT visit, expected average 6 months
|
Blood samples for serum PK analysis will be obtained (Css, avg).
|
Through treatment until EOT visit, expected average 6 months
|
|
Terminal half-life (T1/2) of EMB-15
Periodo de tiempo: Through treatment until EOT visit, expected average 6 months.
|
Blood samples for serum PK analysis will be obtained (T1/2)
|
Through treatment until EOT visit, expected average 6 months.
|
|
Systemic clearance (CL) of EMB-15
Periodo de tiempo: Through treatment until EOT visit, expected average 6 months.
|
Blood samples for serum PK analysis will be obtained (CL).
|
Through treatment until EOT visit, expected average 6 months.
|
|
Steady state volume of distribution (Vss) of EMB-15
Periodo de tiempo: Through treatment until EOT visit, expected average 6 months
|
Blood samples for serum PK analysis will be obtained (Vss).
|
Through treatment until EOT visit, expected average 6 months
|
|
Progression free survival (PFS) of EMB-15 as assessed by RECIST 1.1
Periodo de tiempo: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
|
Preliminary anti-tumor activity of EMB-15 will be obtained (PFS).
|
From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
|
|
Duration of response of EMB-15 as assessed by RECIST 1.1
Periodo de tiempo: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
|
Preliminary anti-tumor activity of EMB-15 will be obtained (DOR).
|
From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
|
|
Incidence and titer of anti-drug antibodies stimulated by EMB-15
Periodo de tiempo: Up to End of Treatment Follow Up Period (30 days after the last dose)
|
Antibodies to EMB-15 will be assessed to evaluate potential immunogenicity.
|
Up to End of Treatment Follow Up Period (30 days after the last dose)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
26 de mayo de 2026
Finalización primaria (Estimado)
31 de mayo de 2029
Finalización del estudio (Estimado)
30 de octubre de 2029
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de mayo de 2026
Publicado por primera vez (Actual)
26 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
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. .