Un Estudio de Primera Aplicación en Humanos de BG-C0979 en Adultos con Tumores Sólidos Avanzados
Un estudio multicéntrico, abierto, de fase 1a/b, primero en humanos, para investigar la seguridad, tolerabilidad, farmacocinética y actividad antitumoral preliminar de BG-C0979 en pacientes con tumores sólidos avanzados seleccionados
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Study Director
- Número de teléfono: 8778285568
- Correo electrónico: clinicaltrials@beonemed.com
Ubicaciones de estudio
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New South Wales
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Frenchs Forest, New South Wales, Australia, NSW 2086
- Reclutamiento
- Northern Beaches Hospital
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Liverpool, New South Wales, Australia, NSW 2170
- Reclutamiento
- Liverpool Hospital
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Queensland
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South Brisbane, Queensland, Australia, QLD 4101
- Reclutamiento
- Icon Cancer Centre South Brisbane
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Victoria
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Malvern, Victoria, Australia, VIC 3144
- Reclutamiento
- Cabrini Hospital Malvern
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Barcelona, España, 08036
- Reclutamiento
- Hospital Clinic de Barcelona
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Barcelona, España, 08035
- Reclutamiento
- Hospital Universitario Vall Dhebron
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Madrid, España, 28040
- Reclutamiento
- Hospital Universitario Fundacion Jimenez Diaz
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Madrid, España, 28223
- Reclutamiento
- Next Oncology Madrid
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215-5418
- Reclutamiento
- Dana Farber Cancer Institute
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Missouri
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St Louis, Missouri, Estados Unidos, 63110-1010
- Reclutamiento
- Washington University School of Medicine
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Reclutamiento
- John Theurer Cancer Center Hackensack University Medical Center
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- Reclutamiento
- Next Oncology San Antonio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100021
- Reclutamiento
- Cancer Hospital Chinese Academy of Medical Sciences
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Porcelana, 400037
- Reclutamiento
- Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
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Fujian
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Fuzhou, Fujian, Porcelana, 350028
- Reclutamiento
- Mengchao Hepatobiliary Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510245
- Reclutamiento
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
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Hubei
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Yichang, Hubei, Porcelana, 443003
- Reclutamiento
- Yichang Central Peoples Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 201321
- Reclutamiento
- Fudan University Shanghai Cancer Centerpudong
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.
- Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have adequate organ function.
Exclusion Criteria:
- Prior treatment with any ADAM9 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- 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: Phase 1a: Monotherapy Dose Escalation
Participants will receive increasing doses of BG-C0979 as monotherapy. |
Administered by intravenous infusion. |
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Experimental: Phase 1a: Monotherapy Safety Expansion
Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion. |
Administered by intravenous infusion. |
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Experimental: Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion
Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a. |
Administered by intravenous infusion. |
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Experimental: Phase 1b, Part B: Combination Therapy Expansion
Participants will receive BG-C0979 in combination with tislelizumab in select tumor types. |
Administered by intravenous infusion. Administered by intravenous infusion.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Periodo de tiempo: Up to approximately 24 months
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including dose limiting toxicities (DLTs), AEs meeting protocol-defined adverse event of clinical interest (AECI) criteria, laboratory values, and electrocardiogram results. |
Up to approximately 24 months
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Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy
Periodo de tiempo: Up to approximately 10 months
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MTD or MAD, defined as the highest dose for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively. |
Up to approximately 10 months
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Phase 1a: Recommended Dose(s) for Expansion (RDFE[s])
Periodo de tiempo: Up to approximately 10 months
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The potential RDFE(s) of BG-C0979 will be determined based on the totality of data including the MTD or MAD, long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available. |
Up to approximately 10 months
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Phase 1b: Recommended Phase 2 Dose (RP2D)
Periodo de tiempo: Up to approximately 24 months
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RP2D of BG-C0979 alone and in combination with tislelizumab will be determined based on safety, PK, preliminary antitumor activity, and other relevant data, as available. |
Up to approximately 24 months
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Phase 1b: Overall Response Rate (ORR)
Periodo de tiempo: Up to approximately 24 months
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ORR as determined from tumor assessment by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For castration-resistant prostate cancer (CRPC), ORR will be assessed by RECIST v1.1 criteria for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR). |
Up to approximately 24 months
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fase 1a: Concentración plasmática de BG-C0979
Periodo de tiempo: Hasta aproximadamente 3 meses
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Hasta aproximadamente 3 meses
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Fase 1a: Área Bajo la Curva de Concentración-Tiempo (AUC) para BG-C0979
Periodo de tiempo: Hasta aproximadamente 3 meses
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Hasta aproximadamente 3 meses
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Fase 1a: Concentración máxima observada (Cmax) de BG-C0979
Periodo de tiempo: Hasta aproximadamente 3 meses
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Hasta aproximadamente 3 meses
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Fase 1a: Tiempo hasta la Concentración Máxima (Tmax) de BG-C0979
Periodo de tiempo: Hasta aproximadamente 3 meses
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Hasta aproximadamente 3 meses
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Fase 1b: Concentración plasmática de BG-C0979, solo y en combinación con Tislelizumab
Periodo de tiempo: Hasta aproximadamente 3 meses
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Hasta aproximadamente 3 meses
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Phase 1a: ORR
Periodo de tiempo: Up to approximately 24 months
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ORR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, ORR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR). |
Up to approximately 24 months
|
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Phase 1a and 1b: Duration of Response (DOR)
Periodo de tiempo: Up to approximately 24 months
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DOR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DOR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
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Phase 1a and 1b: Disease Control Rate (DCR)
Periodo de tiempo: Up to approximately 24 months
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DCR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DCR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DCR is defined as the percentage of participants with best overall response of a CR, PR, or stable disease. |
Up to approximately 24 months
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Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
Periodo de tiempo: Up to approximately 24 months
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Number of participants with TEAEs and SAEs, including AECIs, laboratory values, and electrocardiogram results. |
Up to approximately 24 months
|
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Phase 1b: Progression-Free Survival
Periodo de tiempo: Up to approximately 24 months
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PFS is defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
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Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC
Periodo de tiempo: Up to approximately 24 months
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rPFS is defined as the time from the date of the first administration of study drug(s) to the date of the first objective evidence of radiographic disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
|
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Prostate-Specific Antigen (PSA) Response for Participants with CRPC
Periodo de tiempo: Up to approximately 24 months
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PSA response is defined as a ≥50% decrease in PSA level from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later. |
Up to approximately 24 months
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Study Director, BeOne Medicines
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- BG-C0979-101
- 2025-524857-15-00 (Ctis)
- CTR20261327 (Otro identificador: ChinaDrugTrials)
- 2025 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Marco de tiempo para compartir IPD
See plan description
Criterios de acceso compartido de IPD
See plan description
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
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.
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. .