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A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)

2026年9月15日 更新者：Merck Sharp & Dohme LLC

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Researchers are looking for new ways to treat children with relapsed or refractory solid tumors:

  • Relapsed means the cancer came back after treatment
  • Refractory means the cancer did not respond (get smaller or go away) to treatment
  • Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids

The study treatment I-DXd (also known as MK-2400 or ifinatamab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn:

  • About the safety of I-DXd and if children younger than 12 years old tolerate it
  • How many children who receive I-DXd have the cancer get smaller or go away

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This study will have 2 parts: Part 1 will evaluate the safety and tolerability and determine the recommended dose for expansion (RDE) of I-DXd, followed by Part 2 an efficacy expansion.

研究の種類

介入

入学 (推定)

134

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
    • California
      • Los Angeles、California、アメリカ、90027
        • 募集
        • Children's Hospital Los Angeles ( Site 4006)
        • コンタクト：
          • Study Coordinator
          • 電話番号：323-361-2121
    • Colorado
      • Aurora、Colorado、アメリカ、80045
        • 募集
        • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)
        • コンタクト：
          • Study Coordinator
          • 電話番号：720-777-6740
    • Iowa
      • Iowa City、Iowa、アメリカ、52242
        • 募集
        • University of Iowa Hospitals ( Site 4017)
        • コンタクト：
          • Study Coordinator
          • 電話番号：319-356-2296
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
        • 募集
        • Dana Farber Cancer Center ( Site 4013)
        • コンタクト：
          • Study Coordinator
          • 電話番号：617-632-4580
    • Michigan
      • Grand Rapids、Michigan、アメリカ、49503
        • 募集
        • Corewell Health ( Site 4001)
        • コンタクト：
          • Study Coordinator
          • 電話番号：616-486-0746
    • New Jersey
      • New Brunswick、New Jersey、アメリカ、08901
        • 募集
        • Rutgers Cancer Institute of New Jersey ( Site 4008)
        • コンタクト：
          • Study Coordinator
          • 電話番号：732-235-2465
    • New York
      • New York、New York、アメリカ、10065
        • 募集
        • Memorial Sloan Kettering Cancer Center ( Site 4010)
        • コンタクト：
          • Study Coordinator
          • 電話番号：888-492-8401
      • Valhalla、New York、アメリカ、10595
        • 募集
        • New York Medical College ( Site 4023)
        • コンタクト：
          • Study Coordinator
          • 電話番号：914-614-4270
    • North Dakota
      • Fargo、North Dakota、アメリカ、58102
        • 募集
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003)
        • コンタクト：
          • Study Coordinator
          • 電話番号：701-234-2000
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • 募集
        • Children's Hospital of Philadelphia (CHOP) ( Site 4021)
        • コンタクト：
          • Study Coordinator
          • 電話番号：267-425-5544
    • South Dakota
      • Sioux Falls、South Dakota、アメリカ、57105
        • 募集
        • Sanford Children's Hospital ( Site 4015)
        • コンタクト：
          • Study Coordinator
          • 電話番号：605-312-1000
    • Texas
      • Houston、Texas、アメリカ、77030
        • 募集
        • University of Texas M.D. Anderson Cancer Center ( Site 4007)
        • コンタクト：
          • Study Coordinator
          • 電話番号：713-792-5410
    • Utah
      • Salt Lake City、Utah、アメリカ、84113
        • 募集
        • Intermountain - Primary Children's Hospital ( Site 4014)
        • コンタクト：
          • Study Coordinator
          • 電話番号：801-662-4700
  • イスラエル
      • Haifa、イスラエル、3109601
        • 募集
        • Rambam Health Care Campus ( Site 4674)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+97247776755
      • Ramat Gan、イスラエル、5265601
        • 募集
        • Sheba Medical Center ( Site 4675)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+97235302996
  • スウェーデン
    • Västra Götaland County
      • Gothenburg、Västra Götaland County、スウェーデン、416 85
        • 募集
        • Sahlgrenska Universitetssjukhuset ( Site 4634)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+46313435865
  • スペイン
      • Barcelona、スペイン、08035
        • 募集
        • Hospital Universitari Vall d Hebron ( Site 4716)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+34934893093
    • Barcelona
      • Esplugues de Llobregat、Barcelona、スペイン、8950
        • 募集
        • Hospital Sant Joan de Déu ( Site 4717)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+34671600093
    • Madrid, Comunidad de
      • Madrid、Madrid, Comunidad de、スペイン、28009
        • 募集
        • Hospital Niño Jesús ( Site 4715)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+34915035900
  • デンマーク
    • Capital Region
      • Copenhagen、Capital Region、デンマーク、DK-2100
        • 募集
        • Rigshospitalet ( Site 4467)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+4535455002
  • フランス
    • Aquitaine
      • Bordeaux、Aquitaine、フランス、33076
        • 募集
        • Bordeaux University Hospital - Pellegrin ( Site 4105)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+33 5 56 79 56 79
    • Loire-Atlantique
      • Nantes、Loire-Atlantique、フランス、44093
        • 募集
        • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 4104)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+33240087805
    • Rhone
      • Lyon、Rhone、フランス、69373
        • 募集
        • CENTRE LEON BERARD ( Site 4100)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+33469166572
  • ベルギー
    • Oost-Vlaanderen
      • Ghent、Oost-Vlaanderen、ベルギー、9000
        • 募集
        • UZ Gent ( Site 4428)
        • コンタクト：
          • Study Coordinator
          • 電話番号：+32 9 332 16 53
  • 韓国
      • Seoul、韓国、03080
        • 募集
        • Seoul National University Hospital-Pediatrics ( Site 4972)
        • コンタクト：
          • Study Coordinator
          • 電話番号：82220723304
      • Seoul、韓国、05505
        • 募集
        • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973)
        • コンタクト：
          • Study Coordinator
          • 電話番号：82230105994

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

  • 子

健康ボランティアの受け入れ

いいえ

説明

The main inclusion criteria include but are not limited to the following:

  • In Part 1, participant has recurrent or relapsed, refractory solid tumors (excluding primary central nervous system (CNS)); and in Part 2, participant has recurrent or relapsed, refractory and histologically confirmed diagnosis of osteosarcoma (OST), neuroblastoma (NBL), rhabdomyosarcoma (RMS), or Wilms tumor (WT). All participants must meet the following criteria: Has documented radiological disease progression after at least 1 line of prior therapy in the locally advanced/metastatic setting and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens).
  • Is an individual of any sex/gender, ≥1 month to <12 years of age for Part 1 and ≥1 month to <18 years for Part 2 at the time of providing the informed consent or assent, as applicable
  • Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

The main exclusion criteria include but are not limited to the following:

  • Has clinically significant corneal disease
  • Has a history of cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event within 6 months before screening
  • Has uncontrolled or significant cardiovascular disease, including conduction abnormalities, hypertension, ischemic heart disease, heart failure, and peripheral vascular disease
  • Has any history of interstitial lung disease (ILD)/pneumonitis, irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids, current ILD, or Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
  • Has clinically severe respiratory compromise resulting from intercurrent pulmonary illnesses
  • Has an active, known or suspected autoimmune disease.
  • Has history of solid organ transplant.
  • Has history of allogeneic stem cell transplant (SCT).
  • Has known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease/spinal cord compression. Participants with untreated and asymptomatic brain metastases or previously treated brain metastases may participate provided they are radiologically stable, (i.e, without evidence of progression) for at least 4 weeks
  • Has history of human immunodeficiency virus (HIV) infection.
  • Has known additional malignancy that is progressing or has required active treatment within the past 1 year.
  • Has active infection requiring systemic therapy
  • Has known hypersensitivity or contraindication to either the study intervention substance or inactive ingredients in the study intervention product
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications

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：なし
  • 介入モデル：単一グループの割り当て
  • 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：Ifinatamab Deruxtecan
Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression
生物学的：Ifinatamab Deruxtecan
IV infusion
他の名前：
  • DS-7300a
  • I-DXd
  • MK-2400

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: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT)
時間枠：Cycle 1 (up to approximately 21 days); each cycle is 21 days
A DLT is any of a prespecified list of adverse events (AEs) that occur during Cycle 1 (up to 21 days) if attributed to the study treatment and not attributed to any other clearly identifiable cause. The percentage of participants who experience DLTs will be reported. Each cycle is 21 days.
Cycle 1 (up to approximately 21 days); each cycle is 21 days
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience One or More Adverse Events (AEs)
時間枠：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.
Up to approximately 5 years
Part 1: Number of Participants From ≥1 Month to <12 Years Who Discontinue Study Intervention Due to an AE
時間枠：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5 years
Part 1: Number of Participants From ≥1 Month to <12 Years Who Receive Dose Modifications Due to AEs
時間枠：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who receive dose modification due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Objective Response Rate (ORR) for Participants with neuroblastoma (NBL), rhabdomyosarcoma (RMS), and Wilms tumor (WT)
時間枠：Up to approximately 5 years
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Disease Control Success at 4 Months (DCS-4) for Participants with osteosarcoma (OST)
時間枠：Up to 4 Months
DCS-4 is defined as no occurrence of disease progression per disease specific criteria as assessed by investigator or death due to any cause by Month 4 following the first administration of study intervention for participants with OST. Participants who discontinue from study for any reason prior to completing the third post baseline (or at least 16 weeks) response assessments will be considered disease control failures.
Up to 4 Months

二次結果の測定

結果測定
メジャーの説明
時間枠
パート1およびパート2：全生存（OS）
時間枠：約5年まで
OSは、あらゆる原因による研究治療の最初の投与から死までの時間として定義されます。
約5年まで
Part 1 and Part 2: Duration of Response (DOR) For Participants With NBL, RMS, WT, or OST
時間枠：Up to approximately 5 years
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Disease Control Rate (DCR) For Participants With NBL, RMS, WT, or OST
時間枠：Up to approximately 5 years
DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm). Note: The appearance of one or more new lesions is also considered PD. The time from the first dose until the date of SD must be greater than or equal to 6 weeks. The DCR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Time to Response (TTR) For Participants With NBL, RMS, WT, or OST
時間枠：Up to approximately 5 years
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, TTR is defined as the time from the first dose to the first documented evidence of a CR or PR. The TTR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Progression-free Survival (PFS) For Participants With NBL, RMS, WT, or OST
時間枠：Up to approximately 5 years
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: ORR For participants with OST
時間枠：Up to approximately 5 years
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants with OST who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Experience an AE
時間枠：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Discontinue Study Treatment Due to an AE
時間枠：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Receive Dose Modification Due to an AE
時間枠：Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who receive dose modification due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of I-Dxd
時間枠：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Cmax of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Area under the concentration time curve from Time 0 to the End of the Dosing Period (AUCtau) of I-Dxd
時間枠：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the AUCtau of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of I-Dxd
時間枠：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Ctrough of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of released drug payload (Dxd)
時間枠：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Cmax of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Area under the concentration time curve from Time 0 to the End of the Dosing Period (AUCtau) of Dxd
時間枠：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the AUCtau of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Dxd
時間枠：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Ctrough of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Number of Participants with antidrug antibodies (ADA) against I-Dxd
時間枠：At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to assess I-Dxd immunogenicity by determining the incidence of ADA of I-Dxd.
At designated timepoints (up to approximately 5 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

Merck Sharp & Dohme LLC

協力者

Daiichi Sankyo

捜査官

  • スタディディレクター：Medical Director、Merck Sharp & Dohme LLC

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7月6日

一次修了 (推定)

2031年8月17日

研究の完了 (推定)

2031年8月17日

試験登録日

最初に提出

2026年6月1日

QC基準を満たした最初の提出物

2026年6月1日

最初の投稿 (実際)

2026年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月17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15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

追加の関連 MeSH 用語

その他の研究ID番号

  • 9999-01D
  • 2025 (米国 NIH グラント/契約：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • LIGHTBEAM-U01 (その他の識別子：MSD)
  • U1111-1322-6561 (レジストリ識別子：UTN)
  • 2025-522339-32-00 (レジストリ識別子：EU CT)
  • MK-9999-01D (その他の識別子：MSD)

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

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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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