RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT06941272

Registry updated: 2026-10-06

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Description

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

Interventions

Patritumab Deruxtecan (Biological)
IV Infusion

Eligibility criteria

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 interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD/pneumonitis, or suspected ILD/pneumonitis, or ILD that cannot be ruled out by imaging * 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

Conditions

Malignant Neoplasm

Locations

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
Yale New Haven Hospital ( Site 3012) — New Haven, Connecticut, 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
Royal Children's Hospital ( Site 3994) — Parkville, Victoria, Australia
UZ Gent ( Site 3428) — Ghent, Oost-Vlaanderen, Belgium
Hospital de Clinicas de Porto Alegre ( Site 3265) — Porto Alegre, Rio Grande do Sul, Brazil
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
Alberta Children's Hospital ( Site 3227) — Calgary, Alberta, Canada
The Hospital for Sick Children ( Site 3225) — Toronto, Ontario, Canada
Hospital Carlos Van Buren ( Site 3880) — Valparaíso, Valparaiso, Chile
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
UniversitaetsklInikum Tuebingen ( Site 3142) — Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Koeln. Klinik und Poliklinik ( Site 3145) — Cologne, North Rhine-Westphalia, Germany
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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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