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Recruiting Phase 1/2 NCT06941272

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

Phase 1/2 – combined early trial
Conditions: Malignant Neoplasm

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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
Description
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)
Who can participate
The main inclusion criteria include but are not limited to the following: * 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 (ie, is ineligible for other standard treatment regimens) * 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 The main exclusion criteria include but are not limited to the following: * 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 (ie, without evidence of progression) 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
Locations 22
Australia (1)
Sydney Children's Hospital-Kids Cancer Centre ( Site 3997)
Sydney , New South Wales
Study Coordinator
Belgium (1)
UZ Gent ( Site 3428)
Ghent , Oost-Vlaanderen
Study Coordinator
Brazil (1)
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3264)
Barretos , São Paulo
Study Coordinator
Canada (1)
The Hospital for Sick Children ( Site 3225)
Toronto , Ontario
Study Coordinator
Chile (1)
Hospital Carlos Van Buren ( Site 3880)
Valparaíso , Valparaiso
Study Coordinator
Colombia (1)
Hospital Pablo Tobon Uribe ( Site 3923)
Medellín , Antioquia
Study Coordinator
Czech Republic (1)
Detska nemocnice FN Brno ( Site 3388)
Brno , Brno-mesto
Study Coordinator
Denmark (1)
Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 3467)
Copenhagen , Capital Region
Study Coordinator
France (1)
Bordeaux University Hospital - Pellegrin ( Site 3105)
Bordeaux , Aquitaine
Study Coordinator
Greece (1)
Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 3797)
Athens , Attica
Study Coordinator
Hungary (1)
Semmelweis University ( Site 3838)
Budapest , Pest County
Study Coordinator
Israel (1)
Rambam Health Care Campus ( Site 3674)
Haifa
Study Coordinator
Italy (1)
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 3552)
Milan
Study Coordinator
Netherlands (1)
Prinses Maxima Centrum voor Kinderoncologie ( Site 3510)
Utrecht
Study Coordinator
Slovakia (1)
Narodny ustav detskych chorob ( Site 3592)
Bratislava , Bratislava Region
Study Coordinator
South Korea (1)
Seoul National University Hospital-Pediatrics ( Site 3972)
Seoul
Study Coordinator
Spain (1)
Hospital Sant Joan de Déu ( Site 3717)
Esplugues de Llobregat , Barcelona
Study Coordinator
Sweden (1)
Sahlgrenska Universitetssjukhuset ( Site 3634)
Gothenburg , Västra Götaland County
Study Coordinator
Taiwan (1)
National Taiwan University Hospital ( Site 3983)
Taiwan , Taipei
Study Coordinator
Turkey (1)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 3961)
Ankara
Study Coordinator
United Kingdom (1)
Birmingham Children's Hospital ( Site 3349)
Birmingham , England
Study Coordinator
United States (1)
Childrens Hospital Los Angeles ( Site 3006)
Los Angeles , California
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Month
Maximum age
17 Years
Healthy volunteers
No
Start date
26.05.2025
Completion date
30.12.2030
Registry ID
NCT06941272
Source
anzctr
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