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An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors

2026年11月9日 更新者：BeOne Medicines

一项评估BG-75202单药及联合其他药物治疗晚期实体瘤患者的安全性、耐受性、药代动力学、药效学及初步抗肿瘤活性的1a/1b期研究

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

186

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • 招聘中
        • Beijing Cancer Hospital
      • Beijing、Beijing Municipality、中国、100021
        • 招聘中
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、400030
        • 招聘中
        • Chongqing University Cancer Hospital
    • Fujian
      • Xiamen、Fujian、中国、361003
        • 招聘中
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou、Guangdong、中国、510555
        • 招聘中
        • Sun Yat Sen University Cancer Center Huangpu Branch
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150000
        • 招聘中
        • Harbin Medical University Cancer Hospital
    • Hunan
      • Changsha、Hunan、中国、410013
        • 招聘中
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing、Jiangsu、中国、210036
        • 招聘中
        • Jiangsu Province Hospital Longjiang Branch
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、201321
        • 招聘中
        • Fudan University Shanghai Cancer Centerpudong
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300060
        • 招聘中
        • Tianjin Medical University Cancer Institute and Hospital
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310016
        • 招聘中
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • 意大利
      • Milan、意大利、20141
        • 招聘中
        • Istituto Europeo Di Oncologia
      • Naples、意大利、80131
        • 招聘中
        • Istituto Nazionale Tumori Fondazione G Pascale
      • Roma、意大利、00168
        • 招聘中
        • Fondazione Policlinico Universitario Agostino Gemelli
      • Rozzano、意大利、20089
        • 招聘中
        • Istituto Clinico Humanitas
  • 新西兰
      • Auckland、新西兰、1023
        • 招聘中
        • Auckland City Hospital
  • 澳大利亚
    • New South Wales
      • Blacktown、New South Wales、澳大利亚、NSW 2148
        • 招聘中
        • Blacktown Cancer and Haematology Centre
      • Camperdown、New South Wales、澳大利亚、NSW 2050
        • 招聘中
        • Chris Obrien Lifehouse
    • South Australia
      • Adelaide、South Australia、澳大利亚、SA 5000
        • 招聘中
        • Cancer Research South Australia
    • Victoria
      • Heidelberg、Victoria、澳大利亚、VIC 3084
        • 招聘中
        • Austin Health
      • Melbourne、Victoria、澳大利亚、VIC 3000
        • 招聘中
        • Peter Maccallum Cancer Centre
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294-0004
        • 招聘中
        • University of Alabama At Birmingham Hospital
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • 招聘中
        • Yale Cancer Center
    • Missouri
      • St Louis、Missouri、美国、63110-1010
        • 招聘中
        • Washington University in St Louis
    • Texas
      • Austin、Texas、美国、78758
        • 招聘中
        • Next Oncology Austin
      • Houston、Texas、美国、77030-4009
        • 招聘中
        • The University of Texas Md Anderson Cancer Center
    • Washington
      • Seattle、Washington、美国、98109-4433
        • 招聘中
        • Fred Hutchinson Cancer Research Center
  • 西班牙
      • Barcelona、西班牙、08035
        • 招聘中
        • Hospital Universitario Vall Dhebron
      • Barcelona、西班牙、8023
        • 招聘中
        • Next Oncology Barcelona
      • Madrid、西班牙、28041
        • 招聘中
        • Hospital Universitario 12 de Octubre
      • Madrid、西班牙、28240
        • 招聘中
        • Hospital Clinico San Carlos
      • Málaga、西班牙、29010
        • 招聘中
        • Hospital Universitario Virgen de La Victoria

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy

Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
药品：BG-75202

Administered orally.
实验性的：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.
药品：BG-75202

Administered orally.

药品：Estrogen Receptor Antagonist

Administered by intramuscular injection.
实验性的：Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist

Participants will receive BG-75202 in combination with an estrogen receptor antagonist.
药品：BG-75202

Administered orally.

药品：Estrogen Receptor Antagonist

Administered by intramuscular injection.
实验性的：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.
药品：BG-75202

Administered orally.

药品：CDK4 Inhibitor

Administered orally.

药品：Aromatase Inhibitor

Administered orally.
实验性的：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.
药品：BG-75202

Administered orally.

药品：CDK4 Inhibitor

Administered orally.

药品：Aromatase Inhibitor

Administered orally.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Part 1 and Part 2B (Safety Lead-in): Number of Participants with Adverse Events (AEs)
大体时间：From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months

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
Part 1 and Part 2B (Safety Lead-in): Recommended Dose for Expansion (RDFE)
大体时间：Estimated approximately 1 year

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
Part 2 A and Part 2C: Overall Response Rate (ORR)
大体时间：Up to approximately 2 years

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

次要结果测量

结果测量
措施说明
大体时间
第1和第2部分：BG-75202的最大观察血浆浓度（Cmax）
大体时间：最长约4个月
最长约4个月
第1部分和第2部分：BG-75202的最低观察血浆浓度（Ctrough）
大体时间：最长约4个月
最长约4个月
第1和第2部分：BG-75202的血浆浓度-时间曲线下面积（AUC）
大体时间：最长约4个月
最长约4个月
第一部分和第二部分：BG-75202的终末半衰期（t1/2）
大体时间：最长约4个月
最长约4个月
Part 1 and Part 2B (Safety Lead-in): ORR
大体时间：Up to approximately 1 year

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
Duration of Response (DOR)
大体时间：Up to approximately 2 years

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
Disease Control Rate (DCR)
大体时间：Up to approximately 2 years

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
Clinical Benefit Rate (CBR)
大体时间：Up to approximately 2 years

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
Part 2: Time to Response (TTR)
大体时间：Up to approximately 2 years

TTR is defined as the time from treatment initiation to the first determination of objective response.
Up to approximately 2 years
Part 2A and Part 2C: Progression-Free Survival (PFS)
大体时间：Up to approximately 2 years

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
Part 2A and Part 2C: Number of Participants with Adverse Events (AEs)
大体时间：Up to approximately 2 years

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
Part 2A and Part 2C: Recommended Phase 2 Dose (RP2D) or Recommended Phase 3 Dose (RP3D)
大体时间：Up to approximately 2 years

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

BeOne Medicines

调查人员

  • 研究主任：Study Director、BeOne Medicines

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月11日

初级完成 (估计的)

2029年9月30日

研究完成 (估计的)

2037年1月13日

研究注册日期

首次提交

2025年10月28日

首先提交符合 QC 标准的

2025年10月28日

首次发布 (实际的)

2025年10月29日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月9日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BG-75202-101
  • 2025-523553-34-00 (克蒂斯)
  • 2025 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

IPD 共享时间框架

See plan description

IPD 共享访问标准

See plan description

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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