An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
Un estudio de Fase 1a/1b que evalúa la seguridad, tolerabilidad, farmacocinética, farmacodinámica y actividad antitumoral preliminar de BG-75202, solo y en combinación con otros agentes en pacientes con tumores sólidos avanzados
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75202 (KAT6A/B inhibitor) alone and in combination with other therapies in participants with breast cancer and other advanced solid tumors.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
This study will enroll participants with advanced or metastatic solid tumors, including breast cancer. Breast cancer is one of the most common cancers in women.
BG-75202 is an experimental drug that blocks proteins called KAT6A and 6B. These proteins are believed to help tumor growth in a number of cancers including certain types of breast cancer and other solid tumors. By blocking KAT6A and 6B, BG-75202 may be able to slow down or stop the growth of tumor cells.
This study consists of 2 parts, one called dose escalation and safety expansion and the other called dose optimization and dose expansion.
During the dose escalation and safety expansion part, the study doctors will test different doses of the study drug. This part of the study will evaluate BG-75202 alone (monotherapy) and combined with another drug (combination therapy).
During the dose optimization and dose expansion part, the study doctors will test the study drug in a larger number of people using the dose(s) identified from dose escalation and safety expansion. In this part of the study, BG-75202 will be taken with 1 or 2 other drugs.
The study will enroll participants with advanced or metastatic solid tumors at multiple centers worldwide.
The overall time to participate in this study may be up to approximately five years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
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: 877-828-5568
- Correo electrónico: clinicaltrials@beonemed.com
Ubicaciones de estudio
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New South Wales
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Blacktown, New South Wales, Australia, NSW 2148
- Reclutamiento
- Blacktown Cancer and Haematology Centre
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Camperdown, New South Wales, Australia, NSW 2050
- Reclutamiento
- Chris Obrien Lifehouse
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South Australia
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Adelaide, South Australia, Australia, SA 5000
- Reclutamiento
- Cancer Research South Australia
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Victoria
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Heidelberg, Victoria, Australia, VIC 3084
- Reclutamiento
- Austin Health
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Melbourne, Victoria, Australia, VIC 3000
- Reclutamiento
- Peter Maccallum Cancer Centre
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Barcelona, España, 08035
- Reclutamiento
- Hospital Universitario Vall Dhebron
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Barcelona, España, 8023
- Reclutamiento
- Next Oncology Barcelona
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Madrid, España, 28041
- Reclutamiento
- Hospital Universitario 12 de Octubre
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Madrid, España, 28240
- Reclutamiento
- Hospital Clinico San Carlos
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Málaga, España, 29010
- Reclutamiento
- Hospital Universitario Virgen de La Victoria
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-0004
- Reclutamiento
- University of Alabama At Birmingham Hospital
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Reclutamiento
- Yale Cancer Center
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Missouri
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St Louis, Missouri, Estados Unidos, 63110-1010
- Reclutamiento
- Washington University in St Louis
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Texas
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Austin, Texas, Estados Unidos, 78758
- Reclutamiento
- Next Oncology Austin
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Houston, Texas, Estados Unidos, 77030-4009
- Reclutamiento
- The University of Texas Md Anderson Cancer Center
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Washington
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Seattle, Washington, Estados Unidos, 98109-4433
- Reclutamiento
- Fred Hutchinson Cancer Research Center
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Milan, Italia, 20141
- Reclutamiento
- Istituto Europeo Di Oncologia
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Naples, Italia, 80131
- Reclutamiento
- Istituto Nazionale Tumori Fondazione G Pascale
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Roma, Italia, 00168
- Reclutamiento
- Fondazione Policlinico Universitario Agostino Gemelli
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Rozzano, Italia, 20089
- Reclutamiento
- Istituto Clinico Humanitas
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Auckland, Nueva Zelanda, 1023
- Reclutamiento
- Auckland City Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100142
- Reclutamiento
- Beijing Cancer Hospital
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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, 400030
- Reclutamiento
- Chongqing University Cancer Hospital
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Fujian
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Xiamen, Fujian, Porcelana, 361003
- Reclutamiento
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510555
- Reclutamiento
- Sun Yat Sen University Cancer Center Huangpu Branch
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150000
- Reclutamiento
- Harbin Medical University Cancer Hospital
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Hunan
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Changsha, Hunan, Porcelana, 410013
- Reclutamiento
- Hunan Cancer Hospital
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210036
- Reclutamiento
- Jiangsu Province Hospital Longjiang Branch
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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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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300060
- Reclutamiento
- Tianjin Medical University Cancer Institute and Hospital
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310016
- Reclutamiento
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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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:
- Part 1A: Participants with histologically or cytologically confirmed advanced, metastatic breast cancer and other solid tumors who have exhausted, are intolerant of all available standard of care therapies, and/or without available standard of care therapies.
- Part 1B, Part 2A, 2B, and SE Parts 1A and 1B (except Food Effect): Participants with advanced breast cancer with 1 to 3 prior lines of systemic therapy in the metastatic setting. Prior lines in the advanced/ metastatic setting may not exceed 1 line of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload) in the advanced/metastatic setting.
- Food Effect only in SE Parts 1A or 1B: Patients with histologically or cytologically confirmed advanced, metastatic breast cancer who have exhausted, are intolerant of all available standard-of-care therapies, and/or without available standard-of-care therapies.
- Parts 2C: Participants with advanced breast cancer enrolled in regions where cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are not approved and/or not available as the first-line treatment and who are CDK4/6 inhibitor treatment naïve and did not receive any previous systemic treatment for advanced disease.
- Participants with breast cancer must have histologically or cytologically confirmed advanced breast cancer at the time of most recent testing, based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
- Female participants with metastatic breast cancer must be postmenopausal or receiving ovarian function suppression treatment.
- Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate organ function.
Exclusion Criteria:
- Prior exposure to KAT6A/B or KAT7 inhibitors/degraders.
- Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Participants with any malignancy ≤ 3 years before screening for the study except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively which in the opinion of the investigator is unlikely to require intervention during the study.
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: Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy. |
Administered orally. |
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Experimental: Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist. |
Administered orally. Administered by intramuscular injection. |
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Experimental: Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist
Participants will receive BG-75202 in combination with an estrogen receptor antagonist. |
Administered orally. Administered by intramuscular injection. |
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Experimental: Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor
Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor. |
Administered orally. Administered orally. Administered orally. |
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Experimental: Part 2B: Safety Lead-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor
Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor. |
Administered orally. Administered orally. Administered orally. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Part 1 and Part 2B (Safety Lead-in): Number of Participants with Adverse Events (AEs)
Periodo de tiempo: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, laboratory values, and AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria. |
From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months
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Part 1 and Part 2B (Safety Lead-in): Recommended Dose for Expansion (RDFE)
Periodo de tiempo: Estimated approximately 1 year
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The RDFE is based on the maximum tolerated dose (MTD) or maximum administered dose (MAD) with consideration of the tolerability, pharmacokinetics (PK), pharmacodynamics, antitumor activity, and any other available relevant data. |
Estimated approximately 1 year
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Part 2 A and Part 2C: Overall Response Rate (ORR)
Periodo de tiempo: Up to approximately 2 years
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ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). |
Up to approximately 2 years
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Partes 1 y 2: Concentración plasmática máxima observada (Cmax) de BG-75202
Periodo de tiempo: Hasta aproximadamente 4 meses
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Hasta aproximadamente 4 meses
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Partes 1 y 2: Concentración plasmática mínima observada (Ctrough) de BG-75202
Periodo de tiempo: Hasta aproximadamente 4 meses
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Hasta aproximadamente 4 meses
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Partes 1 y 2: Área Bajo la Curva de Concentración-Tiempo en Plasma (AUC) de BG-75202
Periodo de tiempo: Hasta aproximadamente 4 meses
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Hasta aproximadamente 4 meses
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Partes 1 y 2: Semivida Terminal (t1/2) de BG-75202
Periodo de tiempo: Hasta aproximadamente 4 meses
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Hasta aproximadamente 4 meses
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Part 1 and Part 2B (Safety Lead-in): ORR
Periodo de tiempo: Up to approximately 1 year
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ORR is defined as the percentage of participants with partial response (PR) or complete response (CR), as assessed by the investigator using RECIST v1.1. |
Up to approximately 1 year
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Duration of Response (DOR)
Periodo de tiempo: Up to approximately 2 years
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DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first. |
Up to approximately 2 years
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Disease Control Rate (DCR)
Periodo de tiempo: Up to approximately 2 years
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DCR is defined as the percentage of participants who achieve CR, PR, or stable disease as assessed by investigator's review. |
Up to approximately 2 years
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Clinical Benefit Rate (CBR)
Periodo de tiempo: Up to approximately 2 years
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CBR is defined as the percentage of participants who achieve CR, PR, or durable stable disease (stable disease ≥ 24 weeks). |
Up to approximately 2 years
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Part 2: Time to Response (TTR)
Periodo de tiempo: Up to approximately 2 years
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TTR is defined as the time from treatment initiation to the first determination of objective response. |
Up to approximately 2 years
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Part 2A and Part 2C: Progression-Free Survival (PFS)
Periodo de tiempo: Up to approximately 2 years
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PFS is defined as the time from the date of the first dose of study treatment(s) to the date of the first documentation of disease progression assessed by investigator's review or death, whichever occurs first. |
Up to approximately 2 years
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Part 2A and Part 2C: Number of Participants with Adverse Events (AEs)
Periodo de tiempo: Up to approximately 2 years
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, and laboratory values. |
Up to approximately 2 years
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Part 2A and Part 2C: Recommended Phase 2 Dose (RP2D) or Recommended Phase 3 Dose (RP3D)
Periodo de tiempo: Up to approximately 2 years
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The RP2D or RP3D of BG-75202 will take into consideration the totality of data including, but not limited to, PK, pharmacodynamics, safety, tolerability, and antitumor activity. |
Up to approximately 2 years
|
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
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades de la piel y del tejido conectivo
- Neoplasias de mama
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica.
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Inhibidores de enzimas
- Inhibidores de la síntesis de esteroides
- Antagonistas hormonales
- Antagonistas de estrógenos
- Péptidos
- Aminoácidos, péptidos y proteínas
- Proteínas
- Acciones farmacológicas
- Acciones y usos químicos
- Péptidos de señalización intracelular y proteínas
- Proteínas del ciclo celular
- Proteínas supresoras de tumores
- Proteínas neoplasias
- Proteínas inhibidor de quinasa dependiente de ciclina
- Inhibidores de la aromatasa
- Inhibidor de la quinasa dependiente de ciclina P16
- Antagonistas del Receptor de Estrógeno
Otros números de identificación del estudio
Otros números de identificación del estudio
- BG-75202-101
- 2025-523553-34-00 (Ctis)
- 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. .