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進行性固形腫瘍の参加者を対象にBGB-26808を単独またはティスレリズマブと併用して研究する研究

2026年9月24日 更新者：BeOne Medicines

進行性固形腫瘍患者を対象としたHPK1阻害剤BGB-26808単独または抗PD-1モノクローナル抗体ティスレリズマブとの併用の安全性、忍容性、薬物動態、予備抗腫瘍活性を調査する第1相試験

This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

研究の種類

介入

入学 (推定)

337

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

  • アメリカ
    • California
      • Duarte、California、アメリカ、91010-3012
        • 募集
        • City of Hope National Medical Center
      • Los Angeles、California、アメリカ、90033
        • 募集
        • University of Southern California Norris Comprehensive
    • Connecticut
      • New Haven、Connecticut、アメリカ、06520-8028
        • 募集
        • Yale University Yale Cancer Center
    • Florida
      • Miami、Florida、アメリカ、33136
        • 募集
        • Sylvester Cancer Center, University of Miami
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48109-5316
        • 募集
        • University of Michigan Health System
    • New Jersey
      • Hackensack、New Jersey、アメリカ、07601
        • 募集
        • John Theurer Cancer Center Hackensack University Medical Center
    • New York
      • New York、New York、アメリカ、10029-6504
        • 募集
        • Icahn School of Medicine At Mount Sinai
    • Oregon
      • Portland、Oregon、アメリカ、97213-2933
        • 完了
        • Providence Portland Medical Center
    • Texas
      • Houston、Texas、アメリカ、77030-4009
        • 募集
        • The University of Texas Md Anderson Cancer Center
  • オーストラリア
    • New South Wales
      • Miranda、New South Wales、オーストラリア、NSW 2228
        • 完了
        • Southside Cancer Care
      • North Ryde、New South Wales、オーストラリア、NSW 2109
        • 積極的、募集していない
        • Macquarie University
    • South Australia
      • Kurralta Park、South Australia、オーストラリア、SA 5037
        • 積極的、募集していない
        • Icon Cancer Centre Kurralta Park
    • Western Australia
      • Nedlands、Western Australia、オーストラリア、WA 6009
        • 完了
        • 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、1023
        • 募集
        • Harbour Cancer and Wellness
      • Rotorua、ニュージーランド、3010
        • 募集
        • Health New Zealand Te Whatu Ora Lakes Rotorua Hospital
  • 中国
    • Anhui
      • Hefei、Anhui、中国、230022
        • 募集
        • The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150000
        • 募集
        • Harbin Medical University Cancer Hospital
    • Hubei
      • Wuhan、Hubei、中国、430079
        • 募集
        • Hubei Cancer Hospital
      • Wuhan、Hubei、中国、430101
        • 募集
        • Tongji Hospital,Tongji Medical College of Hustsino French New City Branch
    • Liaoning
      • Shenyang、Liaoning、中国、110167
        • 募集
        • The First Hospital of China Medical University Hunnan Branch
    • Shandong
      • Jining、Shandong、中国、272000
        • 募集
        • Jining No1 Peoples Hospital West Branch
      • Yantai、Shandong、中国、264000
        • 募集
        • Yantai Yuhuangding Hospital
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200123
        • 募集
        • Shanghai East Hospital Branch Hospital
      • Shanghai、Shanghai Municipality、中国、200433
        • 完了
        • Shanghai Pulmonary Hospital
    • Sichuan
      • Chengdu、Sichuan、中国、610071
        • 募集
        • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310006
        • 募集
        • Hangzhou First Peoples Hospital
      • Taizhou、Zhejiang、中国、317004
        • 完了
        • Taizhou Hospital of Zhejiang Province (East)

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  3. Phase 1a: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have previously received standard systemic therapy, or for whom treatment is not available or not tolerated, or for whom treatment is determined not appropriate based on investigator's judgment and who have not received prior therapy targeting hematopoietic progenitor kinase 1 (HPK1).
  4. Phase 1b: Participants with histologically confirmed locally advanced unresectable or metastatic tumor types and who have not had prior systemic treatment. Participants who received prior systemic therapy in a neo-adjuvant or adjuvant setting with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of systemic therapy prior to the first dose of study treatments.
  5. ≥ 1 measurable lesion per RECIST v1.1.
  6. Able to provide an archived tumor tissue sample.
  7. Adequate organ function.
  8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for up to ≥ 270 days after the last dose of chemotherapy.
  9. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for ≥ 180 days after the last dose of chemotherapy.

Exclusion Criteria:

  1. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
  2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
  3. Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
  4. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  5. Active autoimmune diseases or history of autoimmune diseases that may relapse
  6. Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
  7. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment(s).
  8. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
  9. Uncontrolled diabetes.
  10. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).

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：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: Dose Escalation

Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.
薬：BGB-26808

Planned doses administered orally as a tablet daily.

薬：Tislelizumab

Planned doses administered by intravenous infusion.

他の名前：
  • BGB-A317
実験的：Phase 1b: Dose Expansion

Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated.
薬：BGB-26808

Planned doses administered orally as a tablet daily.

薬：Tislelizumab

Planned doses administered by intravenous infusion.

他の名前：
  • BGB-A317
薬：Chemotherapy

Administered in accordance with relevant local guidelines and/or prescribing information.

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
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months

Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
時間枠：Approximately 1 month

MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Approximately 1 month
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
時間枠：Approximately 1 month

RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.
Approximately 1 month
Phase 1b: Overall Response Rate (ORR)
時間枠：Approximately 6 months

ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Approximately 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Phase 1a and 1b: Plasma concentrations of BGB-26808
時間枠：Approximately 6 months
Approximately 6 months
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) for BGB-26808
時間枠：Approximately 1 month
Approximately 1 month
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BGB-26808
時間枠：Approximately 1 month
Approximately 1 month
Phase 1a: ORR
時間枠：Approximately 6 months

ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
Approximately 6 months
Phase 1a and 1b: Duration of Response (DOR)
時間枠：Approximately 9 months

DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
Approximately 9 months
Phase 1a and 1b: Disease Control Rate (DCR)
時間枠：Approximately 6 months

DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator.
Approximately 6 months
Phase 1a and 1b: Clinical Benefit Rate (CBR)
時間枠：Approximately 6 months

CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator.
Approximately 6 months
Phase 1b: Progression Free Survival (PFS)
時間枠：Approximately 9 months

PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Approximately 9 months
Phase 1a and 1b: Time to maximum plasma concentration (Tmax) for BGB-26808
時間枠：Approximately 1 month

Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab. Single-dose and steady-state PK parameters.
Approximately 1 month
Phase 1b: Number of Participants with AEs and SAEs
時間枠：From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months

Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 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 Medicines

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)

2023年9月21日

一次修了 (推定)

2029年2月28日

研究の完了 (推定)

2029年2月28日

試験登録日

最初に提出

2023年7月31日

QC基準を満たした最初の提出物

2023年7月31日

最初の投稿 (実際)

2023年8月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月28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24日

最終確認日

2026年9月1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

  • BGB-A317-26808-101
  • CTR20240210 (その他の識別子：ChinaDrugTrials)

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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