このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers

2026年8月31日 更新者：Boehringer Ingelheim

A Phase Ib/II, Open-label, Safety and Tolerability Trial of Obrixtamig in Combination With ZL-1310 in Patients With Poorly Differentiated NEC

This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. The purpose of Part 2 is to see how obrixtamig and ZL-1310 is tolerated when given with another medicine called a checkpoint inhibitor. Another purpose is to check whether the study treatment can stop the cancer from growing and keep it stable. Obrixtamig and ZL-1310 are being developed to help the immune system fight cancer.

In Part 1, participants get obrixtamig and ZL-1310. In Part 2, participants get obrixtamig and ZL-1310 with a checkpoint inhibitor. Part 2 is only open to people with advanced small cell lung cancer. All study treatments are given as infusions into a vein.

The study does not have a fixed duration. Participants can receive study treatment for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

60

段階

  • フェーズ2
  • 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
    • District of Columbia
      • Washington D.C.、District of Columbia、アメリカ、20007
    • Florida
      • Tampa、Florida、アメリカ、33612
        • H. Lee Moffitt Cancer Center and Research Institute
        • コンタクト：
    • Kentucky
      • Lexington、Kentucky、アメリカ、40536
  • イギリス
      • Leicester、イギリス、LE1 5WW
      • Newcastle upon Tyne、イギリス、NE7 7DN
  • オランダ
      • Amsterdam、オランダ、1081HV
  • オーストラリア
    • New South Wales
      • Camperdown、New South Wales、オーストラリア、2050
  • スペイン
      • L'Hospitalet Del Llobregat、スペイン、08908
        • Hospital Duran i Reynals
        • コンタクト：
      • Madrid、スペイン、28041
        • Hospital Universitario 12 de Octubre
        • コンタクト：
      • Valencia、スペイン、46010
        • Hospital Clinico De Valencia (INCLIVA)
        • コンタクト：
  • ドイツ
      • Mainz、ドイツ、55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • コンタクト：
      • Stuttgart、ドイツ、70376
        • Robert Bosch Gesellschaft für Medizinische Forschung mbH
        • コンタクト：
  • フランス
      • Lyon、フランス、69373
      • Marseille、フランス、13385
      • Villejuif、フランス、94800
        • Institut Gustave Roussy
        • コンタクト：
  • ベルギー
      • Edegem、ベルギー、2650
        • Universitair Ziekenhuis Antwerpen
        • コンタクト：
      • Ghent、ベルギー、9000
        • Universitair Ziekenhuis Gent
        • コンタクト：
  • ポーランド
      • Brzozów、ポーランド、36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
        • コンタクト：
      • Wroclaw、ポーランド、53439
        • Lower Silesian Oncology Centre
        • コンタクト：
  • 中国
      • Nanning、中国、530021
        • The Affiliated Cancer Hospital, Guangxi Medical University
        • コンタクト：
      • Shanghai、中国、200030
        • Shanghai Chest Hospital
        • コンタクト：
      • Shanghai、中国、200433
        • Shanghai Pulmonary Hospital
        • コンタクト：
  • 日本
      • Hokkaido, Sapporo、日本、003-0804
        • Hokkaido Cancer Center
        • コンタクト：
      • Kanagawa, Kawasaki、日本、216-8511
        • St. Marianna University Hospital
        • コンタクト：
      • Osaka, Hirakata、日本、573-1191
        • Kansai Medical University Hospital
        • コンタクト：
      • Shizuoka, Sunto-gun、日本、411-8777
        • Shizuoka Cancer Center
        • 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:

For Part 1

  1. Diagnosed with locally advanced, metastatic or relapsed cancer of the following histologies:

    • Small cell lung carcinoma (SCLC)
    • Large cell neuroendocrine lung carcinoma (LCNEC-L)
    • Extrapulmonary neuroendocrine carcinoma (epNEC) of small or large cell histology
  2. Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small cell component is predominant and represents at least 50% of the overall tumour tissue

  3. Patients for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy, unless there is a documented medical reason not to use platinum

    For Part 2

  4. Histologically or cytologically confirmed extended stage small cell lung cancer (ES-SCLC) (excluding combined histologies) using the American Joint Committee on Cancer (AJCC) tumour node metastasis staging system combined with Veterans Administration Lung Study Group (VALG)'s two stage classification scheme.

  5. Patients must have received no prior systemic therapy for ES-SCLC. Participants with prior chemoradiotherapy for Limited stage small cell lung cancer (LS-SCLC) must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible

    For both Part 1 and Part 2

  6. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses
  7. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF)
  8. Willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, laboratory tests, restrictions regarding prohibited medications, lifestyle restrictions, and other requirements related to the trial. This includes that they are able to understand and follow trial-related instructions
  9. Further inclusion criteria apply.

Exclusion criteria:

  1. Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers (gastrointestinal tract or skin) or laboratory abnormalities that may negatively impact patient safety during trial participation, affect compliance with trial requirements or invalidate assessments relevant for the investigation of the safety and preliminary efficacy of the investigational drugs
  2. Patients with a diagnosis of Merkel cell carcinoma or medullary thyroid cancer
  3. Presence of leptomeningeal disease and/or carcinomatous meningitis
  4. Known hypersensitivity to the trial drugs or their excipients, prior severe, life-threatening hypersensitivity reaction(s) to monoclonal antibodies, or significant risk of allergic or anaphylactic reaction(s) to any of the investigated drug products according to the investigator's judgement
  5. Participants who experienced severe, life-threatening immune-mediated adverse events, e.g. serious Grade 3 or higher immune-related adverse event (imAE) or infusion-related reactions, that led to permanent discontinuation while on treatment with immuno-oncology agents
  6. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, amenorrhea/menstrual disorders, CTCAE Grade 2 peripheral neuropathy, and CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per investigator judgment)
  7. Therapy with any of the following types of treatments or drugs within the noted time intervals prior to IMP administration: At any time: treatment with delta-like ligand 3 (DLL3)-targeting therapies or received more than 30 Gy of thoracic radiotherapy.
  8. Prior organ or tissue allograft
  9. 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：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：Part 1: obrixtamig + ZL-1310 (dosing regimen 1)
薬：オブリクスタミグ
オブリクスタミグ
薬：ZL-1310
ZL-1310
実験的：Part 1: obrixtamig + ZL-1310 (dosing regimen 2)
薬：オブリクスタミグ
オブリクスタミグ
薬：ZL-1310
ZL-1310
実験的：Part 2: obrixtamig + ZL-1310 + atezolizumab
薬：アテゾリズマブ
アテゾリズマブ
薬：オブリクスタミグ
オブリクスタミグ
薬：ZL-1310
ZL-1310

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 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period
時間枠：6 weeks from the first administration of study medication.
6 weeks from the first administration of study medication.
Part 2: The occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification
時間枠：Up to 24 months.
Up to 24 months.
Part 2: PFS rate at 6 months
時間枠：At 6 months.
Progression-free survival (PFS) is defined as the time from first investigational medicinal product (IMP) administration until the earliest date of disease progression according to Response Evaluation Criteria In Solid Tumours (RECIST 1.1) based on investigator assessments or death from any cause, whichever occurs first.
At 6 months.

二次結果の測定

結果測定
メジャーの説明
時間枠
Part 1 and Part 2: Occurrence of treatment-emergent DLTs
時間枠：Up to 24 months.
Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent adverse event of special interest (AESIs)
時間枠：Up to 24 months.
Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent AEs CTCAE Grade ≥3
時間枠：Up to 24 months.
AEs CTCAE = Adverse events Common Terminology Criteria for Adverse Events
Up to 24 months.
Part 1 and Part 2: Objective response (OR)
時間枠：Up to 24 months.
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator assessments) from the first IMP administration until the earliest date of disease progression, death, last evaluable tumour assessment before the start of the next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent.
Up to 24 months.
Part 1 and Part 2: Duration of response (DoR)
時間枠：Up to 24 months.
DoR is defined as the time from the first documented objective response (OR) according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed objective response based on investigator assessments.
Up to 24 months.
Part 1 and Part 2: Disease control (DC)
時間枠：Up to 24 months.
DC is defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST version 1.1 based on investigator assessments from the first IMP administration until the earliest date of disease progression, death or last evaluable tumour assessment before start of the next line of anti-cancer treatment, loss to follow-up or withdrawal of consent.
Up to 24 months.
Part 1: Progression-free survival (PFS)
時間枠：Up to 24 months.
PFS is defined as the time from first IMP administration until the earliest date of disease progression according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first.
Up to 24 months.
Part 2: Occurrence of DLTs during the DLT evaluation period
時間枠：6 weeks from the first administration of study medication.
6 weeks from the first administration of study medication.

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

協力者

Zai Lab

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 (推定)

2026年9月29日

一次修了 (推定)

2030年4月26日

研究の完了 (推定)

2030年4月26日

試験登録日

最初に提出

2026年7月13日

QC基準を満たした最初の提出物

2026年7月13日

最初の投稿 (実際)

2026年7月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月2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31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

追加の関連 MeSH 用語

その他の研究ID番号

  • 1438-0036
  • U1111-1334-0148 (レジストリ識別子：WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-525634-27 (レジストリ識別子：CTIS)

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

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

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

  • SAP
  • ICF
  • 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。

購読する