Last updated 9 days ago
A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
50 patients around the world
Available in United States, Brazil, Colombia
This study will have 2 parts: a safety lead-in to demonstrate a tolerable safety profile
and confirm a preliminary recommended phase 2 dose (RP2D) (Part 1) followed by an
efficacy evaluation (Part 2)
Merck Sharp & Dohme LLC
4Research sites
50Patients around the world
This study is for people with
Solid tumors
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- Has one of the following histologically confirmed advanced or metastatic solid tumors: Rhabdomyosarcoma (RMS), or Hepatoblastoma.Has progressed after at least 1 prior systemic treatment for RMS or hepatoblastoma and who has no satisfactory alternative treatment option.Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have Grade ≤2 neuropathy are eligible.Participants with Grade ≤2 alopecia are also eligible.Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load.Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis that cannot be ruled out by standard diagnostic assessments.Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness.Has a history of solid organ transplant.Has a history of allogeneic stem cell transplant.Has clinically significant corneal disease.Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis/leptomeningeal disease; participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks.Has uncontrolled or significant cardiovascular disorder.Has a history of clinically significant congenital cardiac syndrome.Has a history of human immunodeficiency virus (HIV) infection.Has a known additional malignancy that is progressing or has required active treatment within the past 1 year.Has an active infection requiring systemic therapy.Has concurrent active hepatitis B (HBsAg positive and/or detectable HBV deoxyribonucleic acid [DNA]) and HCV defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid [RNA]) infection.Has not adequately recovered from major surgery or have ongoing surgical complications.
Sites
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Hospital Pablo Tobón Uribe
Recruiting
Clínica de la Costa - Barranquilla
Recruiting
Oncomédica - IMAT - Montería, Colombia
Recruiting
StudyLIGHTBEAM-U01
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Solid tumors
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06941272
