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

15 сентября 2026 г. обновлено: 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

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

134

Фаза

  • Фаза 2
  • Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Toll Free Number
  • Номер телефона: 1-888-577-8839
  • Электронная почта: Trialsites@msd.com

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок

Принимает здоровых добровольцев

Нет

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Ifinatamab Deruxtecan
Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression
Биологический: Ifinatamab Deruxtecan
IV infusion
Другие имена:
  • ДС-7300а
  • I-DXd
  • МК-2400

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Часть 1 и часть 2: общая выживаемость (ОС)
Временное ограничение: Примерно до 5 лет
ОС определяется как время от первой дозы учебного лечения до смерти из -за любой причины.
Примерно до 5 лет
Part 1 and Part 2: Duration of Response (DOR) For Participants With NBL, RMS, WT, or OST
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Merck Sharp & Dohme LLC

Соавторы

Daiichi Sankyo

Следователи

  • Директор по исследованиям: Medical Director, Merck Sharp & Dohme LLC

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

6 июля 2026 г.

Первичное завершение (Оцененный)

17 августа 2031 г.

Завершение исследования (Оцененный)

17 августа 2031 г.

Даты регистрации исследования

Первый отправленный

1 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

1 июня 2026 г.

Первый опубликованный (Действительный)

5 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

17 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

15 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 9999-01D
  • 2025 (Грант/контракт NIH США: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • LIGHTBEAM-U01 (Другой идентификатор: MSD)
  • U1111-1322-6561 (Идентификатор реестра: UTN)
  • 2025-522339-32-00 (Идентификатор реестра: EU CT)
  • MK-9999-01D (Другой идентификатор: MSD)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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