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An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Patients With Myeloid Malignancies

10 de septiembre de 2026 actualizado por: BeOne Medicines

A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BG-75202, Alone and in Combination With Other Agents, in Patients With Myeloid Malignancies

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of BG-75202 (KAT6A/B inhibitor) alone and in combination with other agents in patients with myeloid malignancies.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

118

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

Ubicaciones de estudio

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, NSW 2139
        • Reclutamiento
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australia, NSW 2217
        • Reclutamiento
        • St George Hospital
    • South Australia
      • Kurralta Park, South Australia, Australia, SA 5037
        • Reclutamiento
        • Icon Cancer Centre Kurralta Park
    • Victoria
      • Heidelberg, Victoria, Australia, VIC 3084
        • Reclutamiento
        • Austin Health
    • Western Australia
      • Nedlands, Western Australia, Australia, WA 6009
        • Reclutamiento
        • Linear Clinical Research
  • Nueva Zelanda
      • Auckland, Nueva Zelanda, 1023
        • Reclutamiento
        • Auckland City Hospital
      • Auckland, Nueva Zelanda, 0622
        • Reclutamiento
        • North Shore Hospital
  • Porcelana
    • Gansu
      • Lanzhou, Gansu, Porcelana, 730000
        • Reclutamiento
        • The First Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510000
        • Reclutamiento
        • ZhuJiang Hospital of Southern Medical University
    • Hebei
      • Shijiazhuang, Hebei, Porcelana, 050000
        • Reclutamiento
        • The Second Hospital of Hebei Medical University
    • Henan
      • Zhengzhou, Henan, Porcelana, 451161
        • Reclutamiento
        • The First Affiliated Hospital of Zhengzhou Universitysouth Branch
    • Hubei
      • Wuhan, Hubei, Porcelana, 430030
        • Reclutamiento
        • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
    • Jiangsu
      • Suzhou, Jiangsu, Porcelana, 215006
        • Reclutamiento
        • The First Affiliated Hospital of Soochow University
    • Jiangxi
      • Nanchang, Jiangxi, Porcelana, 330006
        • Reclutamiento
        • The First Affiliated Hospital of Nanchang University Branch Donghu
      • Nanchang, Jiangxi, Porcelana, 332000
        • Reclutamiento
        • The First Affiliated Hospital of Nanchang University Branch Xianghu
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Porcelana, 301617
        • Reclutamiento
        • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

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:

  • Patients must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), inclusive, at the time of signing the Informed consent form (ICF).

  • Patients must have a confirmed diagnosis of myeloid malignancies based on 2016 World Health Organization criteria, and meet the following categories:

    • Relapsed/refractory; myeloid malignancies after ≥1 prior systemic therapy, per ELN; 2022 criteria; patients with actionable genetic alteration must have previously received targeted therapies unless contraindicated, unavailable/inaccessible, or declined by patient.
  • Patients must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

Exclusion Criteria:

  • Prior exposure to KAT6A/B inhibitors/degraders.
  • A diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia.
  • Known central nervous system involvement by leukemia
  • Use of antileukemic therapies without sufficient washout period

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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: No aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Phase 1a: Part A: Dose escalation, BG-75202 monotherapy
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
Droga: BG-75202
Administered orally
Experimental: Phase 1a: Part B: Dose escalation, BG-75202 + Hypomethylation Agent (HMA)
Sequential cohorts of increasing dose levels of BG-75202 in combination with Hypomethylation Agent (HMA) will be evaluated.
Droga: BG-75202
Administered orally
Droga: Hypomethylation Agent (HMA)
Administered Intravenous (IV) or Subcutaneous (SC)
Experimental: Phase 1b: Dose optimization, BG-75202 monotherapy
Participants will receive BG-75202 monotherapy
Droga: BG-75202
Administered orally

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately18 months

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporarily associated with the use of study treatment, whether considered related to study treatment or not.

An SAE is any untoward medical occurrence that, at any dose,

  • Results in death
  • Is life-threatening
  • Requires hospitalization or prolongation of existing hospitalization
  • Results in disability/incapacity
  • Is congenital anomaly/birth defect
  • Is considered a significant medical AE by the investigator based on medical judgement
From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately18 months
Phase 1a: Recommended Dose for Expansion (RDFE) of BG-75202
Periodo de tiempo: Estimated approximately 18 months
The potential RDFE(s) of BG-75202 as monotherapy or in combination with HMA are based upon 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 18 months
Phase 1b: Dose Optimization: Complete Remission (CR) Rate
Periodo de tiempo: Up to approximately 12 months
CR rate is defined as the percentage of participants who achieved a best response of CR as assessed by investigator's review.
Up to approximately 12 months
Phase 1b: Dose Optimization: Complete Remission (CR) plus CR With Partial Hematologic Recovery (CRh) Rate
Periodo de tiempo: Up to approximately 12 months
CR + CRh rate is defined as the percentage of participants who achieved the best response of CR or CRh as assessed by investigator's review.
Up to approximately 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Phase 1b Dose Optimization: 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 18 months
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporarily associated with the use of study treatment, whether considered related to study treatment or not.
From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 18 months
Phase 1b: Time to Response (TTR)
Periodo de tiempo: Up to approximately 12 months
TTR for CR, CR + CRi, CR + CRh, and ORR, defined as the time from the randomization date, to the first determination of the respective objective response.
Up to approximately 12 months
Phase 1b: CR + Complete Remission with Incomplete Hematologic Recovery (CRi) Rate
Periodo de tiempo: Up to approximately 12 months
CR + CRi rate is defined as the percentage of patients who achieved a best response of CR or CRi as assessed by investigator's review.
Up to approximately 12 months
Phase 1a: Dose Escalation: CR + CRh Rate
Periodo de tiempo: Up to approximately 12 months
CR + CRh rate is defined as the percentage of patients who achieved a best response of CR or CRh as assessed by investigator's review.
Up to approximately 12 months
Phase 1a and Phase 1b: Overall response rate (ORR)
Periodo de tiempo: Up to approximately 12 months
ORR is defined as the percentage of participants who achieved a best response of CR, CRh, CRi, or partial response (PR) as assessed by investigator's review.
Up to approximately 12 months
Phase 1b: Event Free Survival (EFS)
Periodo de tiempo: Up to approximately 18 months
EFS, defined as the time from the randomization date for Phase 1b, to the date of first documentation of treatment failure per European LeukemiaNet (ELN) 2022 (refractory disease and relapsed disease) or death due to any cause, whichever occurs first.
Up to approximately 18 months
Phase 1b: Overall Survival (OS)
Periodo de tiempo: Up to approximately 18 months
OS, defined as the time from the randomization date for Phase to the date of death due to any cause.
Up to approximately 18 months
Phase 1b: Transfusion Independence
Periodo de tiempo: Up to approximately 12 months
Transfusion independence, defined as the proportion of patients who achieve red blood cell and/or platelet transfusion independence according to protocol specified criteria, among patients who are transfusion-dependent at baseline.
Up to approximately 12 months
Phase 1a and Phase 1b: Observed Plasma Maximum Concentration (Cmax) of BG-75202
Periodo de tiempo: Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Ctrough) of BG-75202
Periodo de tiempo: Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202
Periodo de tiempo: Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Terminal Half Life (t1/2) of BG-75202
Periodo de tiempo: Up to approximately 5 months
Up to approximately 5 months
Phase 1b: Recommended Phase 2 Dose (RP2D)
Periodo de tiempo: Up to approximately 18 months
The RP2D of BG-75202 takes into consideration the totality of data including, but not limited to, PK, pharmacodynamics, safety, tolerability, and antitumor activity.
Up to approximately 18 months

Colaboradores e Investigadores

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

Patrocinador

BeOne Medicines

Investigadores

  • Director de estudio: Study Director, BeOne Medicine

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)

23 de junio de 2026

Finalización primaria (Estimado)

30 de septiembre de 2028

Finalización del estudio (Estimado)

30 de septiembre de 2028

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2026

Publicado por primera vez (Actual)

1 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de septiembre de 2026

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

10 de septiembre de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • BG-75202-102

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

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.

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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