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

10 de setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

118

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Phase 1a: Part A: Dose escalation, BG-75202 monotherapy
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
Medicamento: 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.
Medicamento: BG-75202
Administered orally
Medicamento: Hypomethylation Agent (HMA)
Administered Intravenous (IV) or Subcutaneous (SC)
Experimental: Phase 1b: Dose optimization, BG-75202 monotherapy
Participants will receive BG-75202 monotherapy
Medicamento: BG-75202
Administered orally

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Part 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Phase 1b Dose Optimization: Number of Participants with Adverse Events (AEs)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Ctrough) of BG-75202
Prazo: 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
Prazo: Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Terminal Half Life (t1/2) of BG-75202
Prazo: Up to approximately 5 months
Up to approximately 5 months
Phase 1b: Recommended Phase 2 Dose (RP2D)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

BeOne Medicines

Investigadores

  • Diretor de estudo: Study Director, BeOne Medicine

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de junho de 2026

Conclusão Primária (Estimado)

30 de setembro de 2028

Conclusão do estudo (Estimado)

30 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

22 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de maio de 2026

Primeira postagem (Real)

1 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de setembro de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • BG-75202-102

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

See plan description

Critérios de acesso de compartilhamento IPD

See plan description

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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