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A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)
Sponsor: Merck Sharp & Dohme LLC
Summary
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
Official title: 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
Key Details
Gender
All
Age Range
1 Month - 17 Years
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2026-07-02
Completion Date
2031-08-17
Last Updated
2026-07-17
Healthy Volunteers
No
Conditions
Interventions
Ifinatamab Deruxtecan
IV infusion
Locations (17)
University of Iowa Hospitals ( Site 4017)
Iowa City, Iowa, United States
Dana Farber Cancer Center ( Site 4013)
Boston, Massachusetts, 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
Children's Hospital of Philadelphia (CHOP) ( Site 4021)
Philadelphia, Pennsylvania, United States
Intermountain - Primary Children's Hospital ( Site 4014)
Salt Lake City, Utah, United States
UZ Gent ( Site 4428)
Ghent, Oost-Vlaanderen, Belgium
Rigshospitalet ( Site 4467)
Copenhagen, Capital Region, Denmark
CENTRE LEON BERARD ( Site 4100)
Lyon, Rhone, France
Rambam Health Care Campus ( Site 4674)
Haifa, Israel
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