A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
Recruiting now · Phase 1/Phase 2
Conditions studied: Malignant Neoplasm
In brief
Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has relapsed or is refractory: * Hepatoblastoma is a common liver cancer in babies and very young children * RMS is a cancer that starts in muscle cells, often in a child's head and neck, bladder, arms, or legs * Relapsed means the cancer came back after treatment * Refractory means the cancer did not respond (get smaller or go away) to treatment The study treatment HER3-DXd (also known as MK-1022 or patritumab 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 HER3-DXd in children and if they tolerate it * What happens to HER3-DXd in children's bodies over time * If children who receive HER3-DXd have the cancer get smaller or go away
Key facts
- Study ID
- NCT06941272
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 50
- Starts
- 2025-05-26
- Expected to finish
- 2030-12-30
- Last updated by the study team
- 2026-07-17
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016) — Aurora, Colorado, United States (enrolling)
- Yale New Haven Hospital ( Site 3012) — New Haven, Connecticut, United States (enrolling)
- Johns Hopkins All Children's Hospital ( Site 3025) — St. Petersburg, Florida, United States (enrolling)
- University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017) — Iowa City, Iowa, United States (enrolling)
- Dana-Farber Cancer Institute ( Site 3013) — Boston, Massachusetts, United States (enrolling)
- Corewell Health ( Site 3001) — Grand Rapids, Michigan, United States (enrolling)
- Children's Mercy Hospital ( Site 3024) — Kansas City, Missouri, United States (enrolling)
- Rutgers Cancer Institute of New Jersey ( Site 3008) — New Brunswick, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center ( Site 3010) — New York, New York, United States (enrolling)
- New York Medical College ( Site 3023) — Valhalla, New York, United States (enrolling)
- Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3003) — Fargo, North Dakota, United States (enrolling)
- Oregon Health and Science University ( Site 3004) — Portland, Oregon, United States (enrolling)
- Children's Hospital of Philadelphia (CHOP) ( Site 3021) — Philadelphia, Pennsylvania, United States (enrolling)
- Sanford Children's Hospital ( Site 3015) — Sioux Falls, South Dakota, United States (enrolling)
- University of Texas-MD Anderson Cancer Center ( Site 3007) — Houston, Texas, United States (enrolling)
- Intermountain - Primary Children's Hospital ( Site 3014) — Salt Lake City, Utah, United States (enrolling)
- Sydney Children's Hospital-Kids Cancer Centre ( Site 3997) — Sydney, New South Wales, Australia (enrolling)
- Queensland Children's Hospital ( Site 3996) — Brisbane, Queensland, Australia (enrolling)
- Royal Children's Hospital ( Site 3994) — Parkville, Victoria, Australia (enrolling)
- UZ Gent ( Site 3428) — Ghent, Oost-Vlaanderen, Belgium (enrolling)
- Hospital de Clinicas de Porto Alegre ( Site 3265) — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
- Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3264) — Barretos, São Paulo, Brazil (enrolling)
- Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3267) — São José do Rio Preto, São Paulo, Brazil (enrolling)
- Alberta Children's Hospital ( Site 3227) — Calgary, Alberta, Canada (enrolling)
- Childrens Hospital Los Angeles ( Site 3006) — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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