drugset / Trial / NCT07630974

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

NCT07630974

Phase 1/2 Recruiting 134 enrolled Merck Sharp & Dohme LLC Daiichi Sankyo · collab
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2026-07-02
Primary completion
2031-08-17
Completion
2031-08-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Ifinatamab Deruxtecan Other / unclassified Intravenous

Indications