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A Study of Ifinatamab Deruxtecan for Pediatric Relapsed or Refractory Solid Tumors

This study is for children aged 1 month to 17 years who have solid tumors that have returned after treatment (relapsed) or did not respond to treatment (refractory). Researchers are testing a treatment called Ifinatamab Deruxtecan, which is an antibody-drug conjugate (ADC). This means it's designed to attach to cancer cells and deliver medicine directly to them. The main goals are to understand how safe Ifinatamab Deruxtecan is for children under 12, how well they tolerate it, and if it can make their tumors shrink or disappear. The study plans to enroll 134 participants, but its current status is unclear.

Study design
This is an interventional study with an unspecified phase, designed to evaluate safety and then effectiveness. It plans to enroll 134 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07630974

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

Recruiting
PHASE1Ages 1–17InterventionalTreatment
Merck Sharp & Dohme LLC
~134 participants
Updated 2026-09-11 on ClinicalTrials.gov
What's tested:Ifinatamab Deruxtecan

At a glance

Recruiting sites
25 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT)
Measured over Cycle 1 (up to approximately 21 days); each cycle is 21 days
+5 more outcomes measured

Conditions

Malignant Neoplasm

Explore related trials

NeuroblastomaOsteosarcomaRhabdomyosarcomaSolid NeoplasmWilms Tumor

NCT07630974

Where you'd take part

This study runs at 25 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973)

    Seoul, South Koreastudy coordinator listed

    Recruiting

  • Bordeaux University Hospital - Pellegrin ( Site 4105)

    Bordeaux, Aquitaine, Francestudy coordinator listed

    Recruiting

  • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 4104)

    Nantes, Loire-Atlantique, Francestudy coordinator listed

    Recruiting

  • CENTRE LEON BERARD ( Site 4100)

    Lyon, Rhone, Francestudy coordinator listed

    Recruiting

  • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)

    Aurora, Coloradostudy coordinator listed

    Recruiting

  • Children's Hospital of Philadelphia (CHOP) ( Site 4021)

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Corewell Health ( Site 4001)

    Grand Rapids, Michiganstudy coordinator listed

    Recruiting

  • Dana Farber Cancer Center ( Site 4013)

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT)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.

  • Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience One or More Adverse Events (AEs)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.

  • Part 1: Number of Participants From ≥1 Month to <12 Years Who Discontinue Study Intervention Due to an AEUp 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.

  • Part 1: Number of Participants From ≥1 Month to <12 Years Who Receive Dose Modifications Due to AEsUp 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.

  • Part 1 and Part 2: Objective Response Rate (ORR) for Participants with neuroblastoma (NBL), rhabdomyosarcoma (RMS), and Wilms tumor (WT)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.

  • Part 1 and Part 2: Disease Control Success at 4 Months (DCS-4) for Participants with osteosarcoma (OST)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.