An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
BG-75202の単独および他の薬剤との併用による進行性固形癌患者における安全性、忍容性、薬物動態、薬力学、および予備的抗腫瘍効果を評価する第1a相／第1b相試験
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 1
連絡先と場所
研究連絡先
研究連絡先
- 名前：Study Director
- 電話番号：877-828-5568
- メール：clinicaltrials@beonemed.com
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294-0004
- 募集
- University of Alabama At Birmingham Hospital
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Connecticut
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New Haven、Connecticut、アメリカ、06510
- 募集
- Yale Cancer Center
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Missouri
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St Louis、Missouri、アメリカ、63110-1010
- 募集
- Washington University in St Louis
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Texas
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Austin、Texas、アメリカ、78758
- 募集
- Next Oncology Austin
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Houston、Texas、アメリカ、77030-4009
- 募集
- The University of Texas Md Anderson Cancer Center
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Washington
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Seattle、Washington、アメリカ、98109-4433
- 募集
- Fred Hutchinson Cancer Research Center
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Milan、イタリア、20141
- 募集
- Istituto Europeo Di Oncologia
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Naples、イタリア、80131
- 募集
- Istituto Nazionale Tumori Fondazione G Pascale
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Roma、イタリア、00168
- 募集
- Fondazione Policlinico Universitario Agostino Gemelli
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Rozzano、イタリア、20089
- 募集
- Istituto Clinico Humanitas
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New South Wales
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Blacktown、New South Wales、オーストラリア、NSW 2148
- 募集
- Blacktown Cancer and Haematology Centre
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Camperdown、New South Wales、オーストラリア、NSW 2050
- 募集
- Chris Obrien Lifehouse
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South Australia
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Adelaide、South Australia、オーストラリア、SA 5000
- 募集
- Cancer Research South Australia
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Victoria
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Heidelberg、Victoria、オーストラリア、VIC 3084
- 募集
- Austin Health
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Melbourne、Victoria、オーストラリア、VIC 3000
- 募集
- Peter Maccallum Cancer Centre
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Barcelona、スペイン、08035
- 募集
- Hospital Universitario Vall Dhebron
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Barcelona、スペイン、8023
- 募集
- Next Oncology Barcelona
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Madrid、スペイン、28041
- 募集
- Hospital Universitario 12 de Octubre
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Madrid、スペイン、28240
- 募集
- Hospital Clinico San Carlos
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Málaga、スペイン、29010
- 募集
- Hospital Universitario Virgen de La Victoria
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Auckland、ニュージーランド、1023
- 募集
- Auckland City Hospital
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100142
- 募集
- Beijing Cancer Hospital
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Beijing、Beijing Municipality、中国、100021
- 募集
- Cancer Hospital Chinese Academy of Medical Sciences
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Chongqing Municipality
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Chongqing、Chongqing Municipality、中国、400030
- 募集
- Chongqing University Cancer Hospital
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Fujian
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Xiamen、Fujian、中国、361003
- 募集
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou、Guangdong、中国、510555
- 募集
- Sun Yat Sen University Cancer Center Huangpu Branch
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Heilongjiang
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Harbin、Heilongjiang、中国、150000
- 募集
- Harbin Medical University Cancer Hospital
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Hunan
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Changsha、Hunan、中国、410013
- 募集
- Hunan Cancer Hospital
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Jiangsu
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Nanjing、Jiangsu、中国、210036
- 募集
- Jiangsu Province Hospital Longjiang Branch
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、201321
- 募集
- Fudan University Shanghai Cancer Centerpudong
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Tianjin Municipality
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Tianjin、Tianjin Municipality、中国、300060
- 募集
- Tianjin Medical University Cancer Institute and Hospital
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Zhejiang
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Hangzhou、Zhejiang、中国、310016
- 募集
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
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）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy. |
Administered orally. |
|
実験的：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. |
Administered orally. Administered by intramuscular injection. |
|
実験的：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. |
|
実験的：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. |
Administered orally. Administered orally. Administered orally. |
|
実験的：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. |
Administered orally. Administered orally. 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
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Part 1 and Part 2B (Safety Lead-in): 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 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
|
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Part 1 and Part 2B (Safety Lead-in): Recommended Dose for Expansion (RDFE)
時間枠：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
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Part 2 A and Part 2C: Overall Response Rate (ORR)
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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第1部および第2部：BG-75202の最大血漿中濃度（Cmax）
時間枠：約4か月まで
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約4か月まで
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パート1および2：BG-75202の最小血漿中濃度（Ctrough）
時間枠：約4か月まで
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約4か月まで
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パート1および2：BG-75202の血漿中濃度-時間曲線下面積（AUC）
時間枠：約4か月まで
|
約4か月まで
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パート1および2：BG-75202の終末半減期（t1/2）
時間枠：約4ヶ月まで
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約4ヶ月まで
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Part 1 and Part 2B (Safety Lead-in): ORR
時間枠：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
|
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Duration of Response (DOR)
時間枠：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
|
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Disease Control Rate (DCR)
時間枠：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
|
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Clinical Benefit Rate (CBR)
時間枠：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
|
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Part 2: Time to Response (TTR)
時間枠：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
|
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Part 2A and Part 2C: Progression-Free Survival (PFS)
時間枠：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
|
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Part 2A and Part 2C: Number of Participants with Adverse Events (AEs)
時間枠：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)
時間枠：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
|
協力者と研究者
捜査官
捜査官
- スタディディレクター：Study Director、BeOne Medicines
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- BG-75202-101
- 2025-523553-34-00 (Ctis)
- 2025 (米国 NIH グラント/契約)
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?
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
米国FDA規制機器製品の研究
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