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Title
Status

 

MK-9999-01C/LIGHTBEAM-U01 - 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

Open

MK-9999-01C/LIGHTBEAM-U01 - 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

Go to Health Care Provider version

DiagnosisRelapsed or refractory hepatoblastoma or rhabdomyosarcoma (RMS)Study StatusOpen
PhaseI/II
Age1 Month to 17 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationBiological: Patritumab Deruxtecan (IV) Other names - MK-1022, HER3-DXd, U3-1402
Last Posted Update2026-03-27
ClinicalTrials.gov #NCT06941272
International Sponsor
Merck Sharp & Dohme LLC
Principal Investigators for Canadian Sites
Montreal Children's Hospital - Dr. Catherine Vézina
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has come back or not responded to other treatment. This study treatment investigating whether HER3-DXd (also known as MK-1022 or patritumab deruxtecan) is safe, effective and how it is absorbed. 

Inclusion Criteria
  • Children and teens (between 1 month to 17 years old) with one of these cancers: hepatoblastoma or rhabdomyosarcoma
  • The cancer must have come back or not responded to treatment
  • Participants must have already tried at least one treatment before and don’t have another good standard option left.
  • Side effects from past treatments should be mild or gone
  • Children who had hepatitis B or C can join if the virus is under control with medicine and no virus is showing up in tests.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.