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RECRUITING

NCT06941272

PHASE1/PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

1 Month - 17 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-26

Completion Date

2030-12-30

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Malignant Neoplasm

Interventions

BIOLOGICAL

Patritumab Deruxtecan

IV Infusion

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 (56)

Childrens Hospital Los Angeles ( Site 3006)

Los Angeles, California, United States

Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016)

Aurora, Colorado, United States

Johns Hopkins All Children's Hospital ( Site 3025)

St. Petersburg, Florida, United States

University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)

Iowa City, Iowa, United States

Dana-Farber Cancer Institute ( Site 3013)

Boston, Massachusetts, United States

Corewell Health ( Site 3001)

Grand Rapids, Michigan, United States

Children's Mercy Hospital ( Site 3024)

Kansas City, Missouri, United States

Rutgers Cancer Institute of New Jersey ( Site 3008)

New Brunswick, New Jersey, United States

Memorial Sloan Kettering Cancer Center ( Site 3010)

New York, New York, United States

New York Medical College ( Site 3023)

Valhalla, New York, United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3003)

Fargo, North Dakota, United States

Oregon Health and Science University ( Site 3004)

Portland, Oregon, United States

Children's Hospital of Philadelphia (CHOP) ( Site 3021)

Philadelphia, Pennsylvania, United States

Sanford Children's Hospital ( Site 3015)

Sioux Falls, South Dakota, United States

University of Texas-MD Anderson Cancer Center ( Site 3007)

Houston, Texas, United States

Intermountain - Primary Children's Hospital ( Site 3014)

Salt Lake City, Utah, United States

Sydney Children's Hospital-Kids Cancer Centre ( Site 3997)

Sydney, New South Wales, Australia

Queensland Children's Hospital ( Site 3996)

Brisbane, Queensland, Australia

UZ Gent ( Site 3428)

Ghent, Oost-Vlaanderen, Belgium

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3264)

Barretos, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3267)

São José do Rio Preto, São Paulo, Brazil

Hospital Pablo Tobon Uribe ( Site 3923)

Medellín, Antioquia, Colombia

Clinica de la Costa S.A.S. ( Site 3924)

Barranquilla, Atlántico, Colombia

IMAT S.A.S ( Site 3921)

Montería, Departamento de Córdoba, Colombia

Detska nemocnice FN Brno ( Site 3388)

Brno, Brno-mesto, Czechia

Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 3387)

Prague, Praha 5, Czechia

Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 3467)

Copenhagen, Capital Region, Denmark

Bordeaux University Hospital - Pellegrin ( Site 3105)

Bordeaux, Aquitaine, France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 3102)

Marseille, Bouches-du-Rhone, France

Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 3104)

Nantes, Loire-Atlantique, France

Centre Leon-Berard ( Site 3100)

Lyon, Rhone, France

Institut Curie ( Site 3101)

Paris, Île-de-France Region, France

Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 3141)

Münster, North Rhine-Westphalia, Germany

Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 3797)

Athens, Attica, Greece

Semmelweis University ( Site 3838)

Budapest, Pest County, Hungary

Rambam Health Care Campus ( Site 3674)

Haifa, Israel

Sheba Medical Center ( Site 3675)

Ramat Gan, Israel

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 3552)

Milan, Italy

Ospedale Pediatrico Bambino Gesù IRCCS ( Site 3553)

Roma, Italy

Ospedale Infantile Regina Margherita ( Site 3551)

Torino, Italy

Prinses Maxima Centrum voor Kinderoncologie ( Site 3510)

Utrecht, Netherlands

Narodny ustav detskych chorob ( Site 3592)

Bratislava, Bratislava Region, Slovakia

Seoul National University Hospital-Pediatrics ( Site 3972)

Seoul, South Korea

Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 3973)

Seoul, South Korea

Hospital Sant Joan de Déu ( Site 3717)

Esplugues de Llobregat, Barcelona, Spain

Hospital Universitari Vall d''Hebron ( Site 3716)

Barcelona, Spain

Hospital Infantil Universitario Nino Jesus ( Site 3715)

Madrid, Spain

Sahlgrenska Universitetssjukhuset ( Site 3634)

Gothenburg, Västra Götaland County, Sweden

National Taiwan University Hospital ( Site 3983)

Taiwan, Taipei, Taiwan

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 3961)

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi. ( Site 3962)

Ankara, Turkey (Türkiye)

Ege Universitesi Hastanesi ( Site 3963)

Izmir, Turkey (Türkiye)

Birmingham Children's Hospital ( Site 3349)

Birmingham, England, United Kingdom

Royal Victoria Infirmary ( Site 3348)

Newcastle upon Tyne, England, United Kingdom

University Hospital of Wales ( Site 3346)

Cardiff, United Kingdom

Royal Marsden Hospital ( Site 3347)

Sutton, United Kingdom