A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)
15 de septiembre de 2026 actualizado por: 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
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
134
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Toll Free Number
- Número de teléfono: 1-888-577-8839
- Correo electrónico: Trialsites@msd.com
Ubicaciones de estudio
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Bélgica, 9000
- Reclutamiento
- UZ Gent ( Site 4428)
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Contacto:
- Study Coordinator
- Número de teléfono: +32 9 332 16 53
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Seoul, Corea del Sur, 03080
- Reclutamiento
- Seoul National University Hospital-Pediatrics ( Site 4972)
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Contacto:
- Study Coordinator
- Número de teléfono: 82220723304
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Seoul, Corea del Sur, 05505
- Reclutamiento
- Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973)
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Contacto:
- Study Coordinator
- Número de teléfono: 82230105994
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Capital Region
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Copenhagen, Capital Region, Dinamarca, DK-2100
- Reclutamiento
- Rigshospitalet ( Site 4467)
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Contacto:
- Study Coordinator
- Número de teléfono: +4535455002
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Barcelona, España, 08035
- Reclutamiento
- Hospital Universitari Vall d Hebron ( Site 4716)
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Contacto:
- Study Coordinator
- Número de teléfono: +34934893093
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Barcelona
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Esplugues de Llobregat, Barcelona, España, 8950
- Reclutamiento
- Hospital Sant Joan de Déu ( Site 4717)
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Contacto:
- Study Coordinator
- Número de teléfono: +34671600093
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, España, 28009
- Reclutamiento
- Hospital Niño Jesús ( Site 4715)
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Contacto:
- Study Coordinator
- Número de teléfono: +34915035900
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California
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Los Angeles, California, Estados Unidos, 90027
- Reclutamiento
- Children's Hospital Los Angeles ( Site 4006)
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Contacto:
- Study Coordinator
- Número de teléfono: 323-361-2121
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Reclutamiento
- Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)
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Contacto:
- Study Coordinator
- Número de teléfono: 720-777-6740
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- Reclutamiento
- University of Iowa Hospitals ( Site 4017)
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Contacto:
- Study Coordinator
- Número de teléfono: 319-356-2296
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Reclutamiento
- Dana Farber Cancer Center ( Site 4013)
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Contacto:
- Study Coordinator
- Número de teléfono: 617-632-4580
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503
- Reclutamiento
- Corewell Health ( Site 4001)
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Contacto:
- Study Coordinator
- Número de teléfono: 616-486-0746
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Reclutamiento
- Rutgers Cancer Institute of New Jersey ( Site 4008)
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Contacto:
- Study Coordinator
- Número de teléfono: 732-235-2465
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New York
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New York, New York, Estados Unidos, 10065
- Reclutamiento
- Memorial Sloan Kettering Cancer Center ( Site 4010)
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Contacto:
- Study Coordinator
- Número de teléfono: 888-492-8401
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Valhalla, New York, Estados Unidos, 10595
- Reclutamiento
- New York Medical College ( Site 4023)
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Contacto:
- Study Coordinator
- Número de teléfono: 914-614-4270
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58102
- Reclutamiento
- Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003)
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Contacto:
- Study Coordinator
- Número de teléfono: 701-234-2000
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Reclutamiento
- Children's Hospital of Philadelphia (CHOP) ( Site 4021)
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Contacto:
- Study Coordinator
- Número de teléfono: 267-425-5544
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Reclutamiento
- Sanford Children's Hospital ( Site 4015)
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Contacto:
- Study Coordinator
- Número de teléfono: 605-312-1000
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Texas
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Houston, Texas, Estados Unidos, 77030
- Reclutamiento
- University of Texas M.D. Anderson Cancer Center ( Site 4007)
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Contacto:
- Study Coordinator
- Número de teléfono: 713-792-5410
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Utah
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Salt Lake City, Utah, Estados Unidos, 84113
- Reclutamiento
- Intermountain - Primary Children's Hospital ( Site 4014)
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Contacto:
- Study Coordinator
- Número de teléfono: 801-662-4700
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Aquitaine
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Bordeaux, Aquitaine, Francia, 33076
- Reclutamiento
- Bordeaux University Hospital - Pellegrin ( Site 4105)
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Contacto:
- Study Coordinator
- Número de teléfono: +33 5 56 79 56 79
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Loire-Atlantique
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Nantes, Loire-Atlantique, Francia, 44093
- Reclutamiento
- Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 4104)
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Contacto:
- Study Coordinator
- Número de teléfono: +33240087805
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Rhone
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Lyon, Rhone, Francia, 69373
- Reclutamiento
- CENTRE LEON BERARD ( Site 4100)
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Contacto:
- Study Coordinator
- Número de teléfono: +33469166572
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Haifa, Israel, 3109601
- Reclutamiento
- Rambam Health Care Campus ( Site 4674)
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Contacto:
- Study Coordinator
- Número de teléfono: +97247776755
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Ramat Gan, Israel, 5265601
- Reclutamiento
- Sheba Medical Center ( Site 4675)
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Contacto:
- Study Coordinator
- Número de teléfono: +97235302996
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Västra Götaland County
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Gothenburg, Västra Götaland County, Suecia, 416 85
- Reclutamiento
- Sahlgrenska Universitetssjukhuset ( Site 4634)
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Contacto:
- Study Coordinator
- Número de teléfono: +46313435865
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Ifinatamab Deruxtecan
Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression
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IV infusion
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT)
Periodo de tiempo: Cycle 1 (up to approximately 21 days); each cycle is 21 days
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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.
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Cycle 1 (up to approximately 21 days); each cycle is 21 days
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Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience One or More Adverse Events (AEs)
Periodo de tiempo: Up to approximately 5 years
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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.
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Up to approximately 5 years
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Part 1: Number of Participants From ≥1 Month to <12 Years Who Discontinue Study Intervention Due to an AE
Periodo de tiempo: Up to approximately 5 years
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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.
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Up to approximately 5 years
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Part 1: Number of Participants From ≥1 Month to <12 Years Who Receive Dose Modifications Due to AEs
Periodo de tiempo: Up to approximately 5 years
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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.
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Up to approximately 5 years
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Part 1 and Part 2: Objective Response Rate (ORR) for Participants with neuroblastoma (NBL), rhabdomyosarcoma (RMS), and Wilms tumor (WT)
Periodo de tiempo: Up to approximately 5 years
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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.
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Up to approximately 5 years
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Part 1 and Part 2: Disease Control Success at 4 Months (DCS-4) for Participants with osteosarcoma (OST)
Periodo de tiempo: Up to 4 Months
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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.
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Up to 4 Months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Parte 1 y Parte 2: Supervivencia general (OS)
Periodo de tiempo: Hasta aproximadamente 5 años
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El SG se define como el tiempo de la primera dosis del tratamiento del estudio hasta la muerte debido a cualquier causa.
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Hasta aproximadamente 5 años
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Part 1 and Part 2: Duration of Response (DOR) For Participants With NBL, RMS, WT, or OST
Periodo de tiempo: Up to approximately 5 years
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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.
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Up to approximately 5 years
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Part 1 and Part 2: Disease Control Rate (DCR) For Participants With NBL, RMS, WT, or OST
Periodo de tiempo: Up to approximately 5 years
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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.
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Up to approximately 5 years
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Part 1 and Part 2: Time to Response (TTR) For Participants With NBL, RMS, WT, or OST
Periodo de tiempo: Up to approximately 5 years
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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.
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Up to approximately 5 years
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Part 1 and Part 2: Progression-free Survival (PFS) For Participants With NBL, RMS, WT, or OST
Periodo de tiempo: Up to approximately 5 years
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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.
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Up to approximately 5 years
|
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Part 1 and Part 2: ORR For participants with OST
Periodo de tiempo: 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.
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Up to approximately 5 years
|
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Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Experience an AE
Periodo de tiempo: 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
|
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Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Discontinue Study Treatment Due to an AE
Periodo de tiempo: 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
|
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Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Receive Dose Modification Due to an AE
Periodo de tiempo: 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.
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Up to approximately 5 years
|
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Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of I-Dxd
Periodo de tiempo: At designated timepoints (up to approximately 5 years)
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Blood samples will be collected at specified intervals to determine the Cmax of I-Dxd.
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At designated timepoints (up to approximately 5 years)
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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
Periodo de tiempo: At designated timepoints (up to approximately 5 years)
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Blood samples will be collected at specified intervals to determine the AUCtau of I-Dxd.
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At designated timepoints (up to approximately 5 years)
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Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of I-Dxd
Periodo de tiempo: At designated timepoints (up to approximately 5 years)
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Blood samples will be collected at specified intervals to determine the Ctrough of I-Dxd.
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At designated timepoints (up to approximately 5 years)
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Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of released drug payload (Dxd)
Periodo de tiempo: At designated timepoints (up to approximately 5 years)
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Blood samples will be collected at specified intervals to determine the Cmax of Dxd.
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At designated timepoints (up to approximately 5 years)
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Part 1 and Part 2: Area under the concentration time curve from Time 0 to the End of the Dosing Period (AUCtau) of Dxd
Periodo de tiempo: At designated timepoints (up to approximately 5 years)
|
Blood samples will be collected at specified intervals to determine the AUCtau of Dxd.
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At designated timepoints (up to approximately 5 years)
|
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Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Dxd
Periodo de tiempo: 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)
|
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Part 1 and Part 2: Number of Participants with antidrug antibodies (ADA) against I-Dxd
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Medical Director, Merck Sharp & Dohme LLC
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de julio de 2026
Finalización primaria (Estimado)
17 de agosto de 2031
Finalización del estudio (Estimado)
17 de agosto de 2031
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
5 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 9999-01D
- 2025 (Subvención/contrato del NIH de EE. UU.: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- LIGHTBEAM-U01 (Otro identificador: MSD)
- U1111-1322-6561 (Identificador de registro: UTN)
- 2025-522339-32-00 (Identificador de registro: EU CT)
- MK-9999-01D (Otro identificador: MSD)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .