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A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab

2026年8月3日 更新者：Boehringer Ingelheim

A First-in-human Phase I, Open-label, Multicentre, Dose Escalation Trial of BI 3819026 in Combination With Ezabenlimab in Patients With Unresectable Advanced or Metastatic Solid Cancers to Determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE)

This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer.

Participants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study.

Participants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.

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)

60

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
    • Connecticut
      • New Haven、Connecticut、アメリカ、06511
    • New Jersey
      • Hackensack、New Jersey、アメリカ、07601
        • まだ募集していません
        • Hackensack University Medical Center
        • コンタクト：
    • New York
      • New York、New York、アメリカ、10016
        • まだ募集していません
        • New York University Langone Medical Center
        • コンタクト：
    • Tennessee
      • Nashville、Tennessee、アメリカ、37203
  • スペイン
      • Barcelona、スペイン、08035
        • 募集
        • Hospital Universitari Vall d'Hebron
        • コンタクト：
      • Pamplona、スペイン、31008
        • 募集
        • Clinica Universidad de Navarra
        • コンタクト：
      • Valencia、スペイン、46010
        • 募集
        • Hospital Clínico Universitario de Valencia
        • コンタクト：
  • 日本
      • Chiba, Kashiwa、日本、277-8577
        • 募集
        • National Cancer Center Hospital East
        • コンタクト：
      • Tokyo, Chuo-ku、日本、104-0045
        • 募集
        • National Cancer Center Hospital
        • コンタクト：

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 :

  1. Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory to or ineligible for established and available therapies with proven clinical benefit, or have declined such therapy.
  2. At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

  3. Patients with brain metastases are eligible provided they meet the following criteria:

    • Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the investigator,
    • Radiotherapy and/or surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,
    • Patient is off steroids and anti-convulsive drugs for at least 7 days prior to the first administration of BI 3819026 and has no requirement for such therapy at the time of initiating trial treatment.
  4. Availability of archived formalin-fixed and paraffin embedded (FFPE) tumour tissue. Patients who do not have archived FFPE tumour tissue available may be allowed to enrol without archival tumour tissue upon agreement between the investigator and the Sponsor
  5. All toxicities related to previous anti-cancer therapies have resolved to Grade ≤1 or baseline prior to trial treatment administration (except for alopecia, peripheral neuropathy and endocrinopathies considered irreversible [like hypothyroidism], and amenorrhea/menstrual disorders which can be any grade)
  6. Adequate liver, bone marrow and renal organ function Further inclusion criteria apply.

Exclusion Criteria :

  1. Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:

    • Effectively treated non-melanoma skin cancers
    • Effectively treated carcinoma in situ of the cervix
    • Effectively treated ductal carcinoma in situ of the breast
    • Other effectively treated malignancy that is considered cured by local treatment
  2. Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)
  3. Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment

  4. Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:

    • Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior and is not on the target lesion (which should be outside of the radiation field)
    • Single dose palliative radiotherapy for symptomatic metastasis that is not the target lesion (which should be outside of the radiation field) within 2 weeks prior may be allowed
  5. Active/previous history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)
  6. Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, e.g. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible
  7. Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)

  8. Patients with history of HIV infection who meet one or more of the following criteria:

    • CD4+ count <350 cells/µL
    • Viral load >400 copies/mL
    • Not receiving antiretroviral therapy
    • Receiving established antiretroviral therapy for less than four weeks prior to the start of trial treatment
    • History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the exclusion criteria above are eligible to participate but the patient must be under the care of an HIV/Infectious Diseases specialist, or an HIV/Infectious Diseases specialist must be consulted prior to inclusion Further exclusion criteria 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：並列代入
  • 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：BI 3819026 + Ezabenlimab (BI 754091) dose group 1
Dose escalation
薬：BI 3819026
BI 3819026
薬：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
実験的：BI 3819026 + Ezabenlimab (BI 754091) dose group 2
Dose escalation
薬：BI 3819026
BI 3819026
薬：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
実験的：BI 3819026 + Ezabenlimab (BI 754091) dose group 3
Dose escalation
薬：BI 3819026
BI 3819026
薬：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
実験的：BI 3819026 + Ezabenlimab (BI 754091) dose group 4
Dose escalation
薬：BI 3819026
BI 3819026
薬：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
実験的：BI 3819026 + Ezabenlimab (BI 754091) dose group 5
Dose escalation
薬：BI 3819026
BI 3819026
薬：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
実験的：BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill
薬：BI 3819026
BI 3819026
薬：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
実験的：BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill
薬：BI 3819026
BI 3819026
薬：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
実験的：BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill
薬：BI 3819026
BI 3819026
薬：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)

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
時間枠
Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period
時間枠：Up to 30 days
Up to 30 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Occurrence of adverse events (AEs) with onset during the on-treatment period
時間枠：Up to 2 years
Up to 2 years
Occurrence of DLTs with onset during the on-treatment period
時間枠：Up to 2 years
Up to 2 years
Occurrence of AEs with onset during Cycle 1
時間枠：Up to 15 days
Up to 15 days
Occurrence of DLTs with onset during Cycle 1
時間枠：Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 1
時間枠：Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 3
時間枠：Up to Day 30
Up to Day 30
Maximum measured concentration of BI 3819026 + ezabenlimab combination (C max) in cycle 3
時間枠：Up to Day 30
Up to Day 30
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 1
時間枠：Up to 15 days
Up to 15 days
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3
時間枠：Up to Day 30
Up to Day 30
Area under concentration-time curve of BI 3819026 + ezabenlimab combination over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3
時間枠：Up to Day 30
Up to Day 30
Treatment-induced changes in target cells as compared with baseline
時間枠：At baseline and up to 2 years
Backfill cohorts only: only patients in whom sequential biopsies are technically feasible and deemed safe by the investigator will be eligible
At baseline and up to 2 years
Treatment-induced changes in target cells ratio as compared with baseline
時間枠：At baseline and up to 2 years
Backfill cohorts only
At baseline and up to 2 years

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

Boehringer Ingelheim

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

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5月1日

一次修了 (推定)

2028年6月5日

研究の完了 (推定)

2030年10月15日

試験登録日

最初に提出

2026年5月18日

QC基準を満たした最初の提出物

2026年5月18日

最初の投稿 (実際)

2026年5月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月4日

QC基準を満たした最後の更新が送信されました

2026年8月3日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2012-0001
  • 2025-522953-21-00 (レジストリ識別子：CTIS)
  • U1111-1328-0914 (レジストリ識別子：WHO International Clinical Trials Registry Platform (ICTRP))

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

Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD 共有時間枠

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD 共有アクセス基準

For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

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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