A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)
Start Date
7/6/2026
Completion Date
8/17/2031
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
Detailed Description
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.
Eligibility Criteria
Age Range: No minimum to 17 years
Interventions
Ifinatamab Deruxtecan
Conditions
Locations
Children's Hospital Los Angeles ( Site 4006)
Los Angeles, California 90027
United States
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)
Aurora, Colorado 80045
United States
Johns Hopkins All Children's Hospital ( Site 4025)
St. Petersburg, Florida 33701
United States
University of Iowa Hospitals ( Site 4017)
Iowa City, Iowa 52242
United States
Dana Farber Cancer Center ( Site 4013)
Boston, Massachusetts 02215
United States
Corewell Health ( Site 4001)
Grand Rapids, Michigan 49503
United States
The Children's Mercy Hospitals & Clinics ( Site 4024)
Kansas City, Missouri 64108
United States
Rutgers Cancer Institute of New Jersey ( Site 4008)
New Brunswick, New Jersey 08901
United States
Memorial Sloan Kettering Cancer Center ( Site 4010)
New York, New York 10065
United States
New York Medical College ( Site 4023)
Valhalla, New York 10595
United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003)
Fargo, North Dakota 58102
United States
Children's Hospital of Philadelphia (CHOP) ( Site 4021)
Philadelphia, Pennsylvania 19104
United States
Sanford Children's Hospital ( Site 4015)
Sioux Falls, South Dakota 57105
United States
University of Texas M.D. Anderson Cancer Center ( Site 4007)
Houston, Texas 77030
United States
Intermountain - Primary Children's Hospital ( Site 4014)
Salt Lake City, Utah 84113
United States
The Royal Children's Hospital ( Site 4994)
Parkville, Victoria 3052
Australia
UZ Gent ( Site 4428)
Ghent, Oost-Vlaanderen 9000
Belgium
Fakultní nemocnice Motol a Homolka ( Site 4387)
Prague, 150 06
Czechia
Rigshospitalet ( Site 4467)
Copenhagen, Capital Region DK-2100
Denmark
Bordeaux University Hospital - Pellegrin ( Site 4105)
Bordeaux, Aquitaine 33076
France
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 4104)
Nantes, Loire-Atlantique 44093
France
CENTRE LEON BERARD ( Site 4100)
Lyon, Rhone 69373
France
Rambam Health Care Campus ( Site 4674)
Haifa, 3109601
Israel
Schneider Children's Medical Center ( Site 4676)
Petah Tikva, 4920235
Israel
Sheba Medical Center ( Site 4675)
Ramat Gan, 5265601
Israel
Prinses Maxima Centrum voor Kinderoncologie ( Site 4510)
Utrecht, 3584 CS
Netherlands
Seoul National University Hospital-Pediatrics ( Site 4972)
Seoul, 03080
South Korea
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973)
Seoul, 05505
South Korea
Hospital Sant Joan de Déu ( Site 4717)
Esplugues de Llobregat, Barcelona 8950
Spain
Hospital Niño Jesús ( Site 4715)
Madrid, Madrid, Comunidad de 28009
Spain
Hospital Universitari Vall d Hebron ( Site 4716)
Barcelona, 08035
Spain
Sahlgrenska Universitetssjukhuset ( Site 4634)
Gothenburg, Västra Götaland County 416 85
Sweden