A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01) (NCT07630974)
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
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: University of Iowa Hospitals ( Site 4017) — Iowa City, Iowa
Age range: 1 Month to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- University of Iowa Hospitals ( Site 4017) — Iowa City, Iowa
- Dana Farber Cancer Center ( Site 4013) — Boston, Massachusetts
- Rutgers Cancer Institute of New Jersey ( Site 4008) — New Brunswick, New Jersey
- Memorial Sloan Kettering Cancer Center ( Site 4010) — New York, New York
- New York Medical College ( Site 4023) — Valhalla, New York
- Children's Hospital of Philadelphia (CHOP) ( Site 4021) — Philadelphia, Pennsylvania
- University of Texas M.D. Anderson Cancer Center ( Site 4007) — Houston, Texas
- Intermountain - Primary Children's Hospital ( Site 4014) — Salt Lake City, Utah
- UZ Gent ( Site 4428) — Ghent, Oost-Vlaanderen
- Rigshospitalet ( Site 4467) — Copenhagen, Capital Region
- Bordeaux University Hospital - Pellegrin ( Site 4105) — Bordeaux, Aquitaine
- CENTRE LEON BERARD ( Site 4100) — Lyon, Rhone
- Rambam Health Care Campus ( Site 4674) — Haifa,
- Sheba Medical Center ( Site 4675) — Ramat Gan,
- Seoul National University Hospital-Pediatrics ( Site 4972) — Seoul,
- Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973) — Seoul,
- Hospital Sant Joan de Déu ( Site 4717) — Esplugues de Llobregat, Barcelona
- Hospital Niño Jesús ( Site 4715) — Madrid, Madrid, Comunidad de
- Hospital Universitari Vall d Hebron ( Site 4716) — Barcelona,
- Sahlgrenska Universitetssjukhuset ( Site 4634) — Gothenburg, Västra Götaland County
📞 Contact the Study Coordinator
Phone: (888) 577-8839
Email: Trialsites@msd.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.