RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07630974

Registry updated: 2026-10-13

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Description

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

Interventions

Ifinatamab Deruxtecan (Biological)
IV infusion

Eligibility criteria

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

Conditions

Malignant Neoplasm

Locations

Children's Hospital Los Angeles ( Site 4006) — Los Angeles, California, United States
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016) — Aurora, Colorado, United States
Johns Hopkins All Children's Hospital ( Site 4025) — St. Petersburg, Florida, United States
University of Iowa Hospitals ( Site 4017) — Iowa City, Iowa, United States
Dana Farber Cancer Center ( Site 4013) — Boston, Massachusetts, United States
Corewell Health ( Site 4001) — Grand Rapids, Michigan, United States
The Children's Mercy Hospitals & Clinics ( Site 4024) — Kansas City, Missouri, United States
Rutgers Cancer Institute of New Jersey ( Site 4008) — New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center ( Site 4010) — New York, New York, United States
New York Medical College ( Site 4023) — Valhalla, New York, United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003) — Fargo, North Dakota, United States
Children's Hospital of Philadelphia (CHOP) ( Site 4021) — Philadelphia, Pennsylvania, United States
Sanford Children's Hospital ( Site 4015) — Sioux Falls, South Dakota, United States
University of Texas M.D. Anderson Cancer Center ( Site 4007) — Houston, Texas, United States
Intermountain - Primary Children's Hospital ( Site 4014) — Salt Lake City, Utah, United States
The Royal Children's Hospital ( Site 4994) — Parkville, Victoria, Australia
UZ Gent ( Site 4428) — Ghent, Oost-Vlaanderen, Belgium
Fakultní nemocnice Motol a Homolka ( Site 4387) — Prague, Czechia
Rigshospitalet ( Site 4467) — Copenhagen, Capital Region, Denmark
Bordeaux University Hospital - Pellegrin ( Site 4105) — Bordeaux, Aquitaine, France
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 4104) — Nantes, Loire-Atlantique, France
CENTRE LEON BERARD ( Site 4100) — Lyon, Rhone, France
Rambam Health Care Campus ( Site 4674) — Haifa, Israel
Schneider Children's Medical Center ( Site 4676) — Petah Tikva, Israel
Sheba Medical Center ( Site 4675) — Ramat Gan, Israel
Prinses Maxima Centrum voor Kinderoncologie ( Site 4510) — Utrecht, Netherlands
Seoul National University Hospital-Pediatrics ( Site 4972) — Seoul, South Korea
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973) — Seoul, South Korea
Hospital Sant Joan de Déu ( Site 4717) — Esplugues de Llobregat, Barcelona, Spain
Hospital Niño Jesús ( Site 4715) — Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d Hebron ( Site 4716) — Barcelona, Spain
Sahlgrenska Universitetssjukhuset ( Site 4634) — Gothenburg, Västra Götaland County, Sweden

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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