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

15 september 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

134

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Ifinatamab Deruxtecan
Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression
Biologisch: Ifinatamab Deruxtecan
IV infusion
Andere namen:
  • DS-7300a
  • I-DXd
  • MK-2400

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Deel 1 en deel 2: Algemene overleving (OS)
Tijdsspanne: Tot ongeveer 5 jaar
OS wordt gedefinieerd als tijd van de eerste dosis studiebehandeling tot de dood als gevolg van enige oorzaak.
Tot ongeveer 5 jaar
Part 1 and Part 2: Duration of Response (DOR) For Participants With NBL, RMS, WT, or OST
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Medewerkers

Daiichi Sankyo

Onderzoekers

  • Studie directeur: Medical Director, Merck Sharp & Dohme LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 juli 2026

Primaire voltooiing (Geschat)

17 augustus 2031

Studie voltooiing (Geschat)

17 augustus 2031

Studieregistratiedata

Eerst ingediend

1 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

15 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 9999-01D
  • 2025 (Subsidie/contract van de Amerikaanse NIH: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • LIGHTBEAM-U01 (Andere identificatie: MSD)
  • U1111-1322-6561 (Register-ID: UTN)
  • 2025-522339-32-00 (Register-ID: EU CT)
  • MK-9999-01D (Andere identificatie: MSD)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren