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

2026年9月10日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

118

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：順次割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Phase 1a: Part A: Dose escalation, BG-75202 monotherapy
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
薬：BG-75202
Administered orally
実験的：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.
薬：BG-75202
Administered orally
薬：Hypomethylation Agent (HMA)
Administered Intravenous (IV) or Subcutaneous (SC)
実験的：Phase 1b: Dose optimization, BG-75202 monotherapy
Participants will receive BG-75202 monotherapy
薬：BG-75202
Administered orally

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Part 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Phase 1b Dose Optimization: Number of Participants with Adverse Events (AEs)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Ctrough) of BG-75202
時間枠：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
時間枠：Up to approximately 5 months
Up to approximately 5 months
Phase 1a and Phase 1b: Terminal Half Life (t1/2) of BG-75202
時間枠：Up to approximately 5 months
Up to approximately 5 months
Phase 1b: Recommended Phase 2 Dose (RP2D)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

BeOne Medicines

捜査官

  • スタディディレクター：Study Director、BeOne Medicine

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月23日

一次修了 (推定)

2028年9月30日

研究の完了 (推定)

2028年9月30日

試験登録日

最初に提出

2026年5月22日

QC基準を満たした最初の提出物

2026年5月22日

最初の投稿 (実際)

2026年6月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月14日

QC基準を満たした最後の更新が送信されました

2026年9月10日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • BG-75202-102

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

See plan description

IPD 共有アクセス基準

See plan description

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • CSR

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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