drugset / Trial / NCT06941272

A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)

NCT06941272

Phase 1/2 Recruiting 50 enrolled Merck Sharp & Dohme LLC Daiichi Sankyo · collab
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2025-05-26
Primary completion
2030-12-30
Completion
2030-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Patritumab deruxtecan Monoclonal antibody Intravenous

Indications