Pediatrics | Soft Tissue, Phase I-II
LIGHTBEAM-U01 Substudy 01C: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors
Volunteers
Health Professionals
What is the purpose of this trial?
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
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Principal Investigator
Sub-Investigators
- Anna Sowa, MD, MHS
- Aron Flagg, MD
- Asher Marks, MD
- Ashley Bowers, PA
- Claudia Auerbach, APRN
- Daniel Prior, MD
- Juan Vasquez, MD
- Lakshmanan Krishnamurti, MD
- Mary Jane Hogan, MD, MPH, FAAP
- Michaela Russell, APRN
- Nitya Bakshi, MBBS, MD, MS
- Prasanna Ananth, MD, MPH
- Rozalyn Levine Rodwin, MD, MHS
- Stephanie Massaro, MD, MPH
- Stephanie Prozora, MD
- Vidya Puthenpura, MD, MHS, FAAP
- Last Updated04/29/2026
- Study IRB#2000040458