A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)
Recruiting now · Phase 1/Phase 2
Conditions studied: Malignant Neoplasm
In brief
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
Key facts
- Study ID
- NCT07630974
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 134
- Starts
- 2026-07-02
- Expected to finish
- 2031-08-17
- Last updated by the study team
- 2026-08-04
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Iowa Hospitals ( Site 4017) — Iowa City, Iowa, United States (enrolling)
- Dana Farber Cancer Center ( Site 4013) — Boston, Massachusetts, United States (enrolling)
- Rutgers Cancer Institute of New Jersey ( Site 4008) — New Brunswick, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center ( Site 4010) — New York, New York, United States (enrolling)
- New York Medical College ( Site 4023) — Valhalla, New York, United States (enrolling)
- Children's Hospital of Philadelphia (CHOP) ( Site 4021) — Philadelphia, Pennsylvania, United States (enrolling)
- Intermountain - Primary Children's Hospital ( Site 4014) — Salt Lake City, Utah, United States (enrolling)
- UZ Gent ( Site 4428) — Ghent, Oost-Vlaanderen, Belgium (enrolling)
- Rigshospitalet ( Site 4467) — Copenhagen, Capital Region, Denmark (enrolling)
- CENTRE LEON BERARD ( Site 4100) — Lyon, Rhone, France (enrolling)
- Rambam Health Care Campus ( Site 4674) — Haifa, Israel (enrolling)
- Sheba Medical Center ( Site 4675) — Ramat Gan, Israel (enrolling)
- Seoul National University Hospital-Pediatrics ( Site 4972) — Seoul, South Korea (enrolling)
- Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973) — Seoul, South Korea (enrolling)
- Hospital Sant Joan de Déu ( Site 4717) — Esplugues de Llobregat, Barcelona, Spain (enrolling)
- Hospital Niño Jesús ( Site 4715) — Madrid, Madrid, Comunidad de, Spain (enrolling)
- Hospital Universitari Vall d Hebron ( Site 4716) — Barcelona, Spain (enrolling)
- Sahlgrenska Universitetssjukhuset ( Site 4634) — Gothenburg, Västra Götaland County, Sweden (enrolling)
Full record on ClinicalTrials.gov
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