Actively Recruiting
A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-12
50
Participants Needed
60
Research Sites
292 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced or metastatic rhabdomyosarcoma (RMS) or hepatoblastoma
- Cancer has progressed after at least 1 prior systemic treatment
- No satisfactory alternative treatment options available
- Recovered to Grade 1 or baseline from adverse events caused by previous cancer therapies
- Participants with endocrine-related adverse events are eligible if treated with hormone replacement
- Participants with Grade 2 neuropathy or Grade 2 alopecia are eligible
- Hepatitis B surface antigen positive participants are eligible if on antiviral therapy with undetectable viral load
- Participants with a history of hepatitis C virus infection are eligible if viral load is undetectable
You will not qualify if you...
- History of interstitial lung disease or pneumonitis requiring steroids, or current/suspected ILD/pneumonitis not ruled out
- Clinically severe respiratory compromise from lung illness
- History of solid organ transplant
- History of allogeneic stem cell transplant
- Clinically significant corneal disease
- Active central nervous system metastases or carcinomatous meningitis/leptomeningeal disease
- Uncontrolled or significant cardiovascular disorder
- History of clinically significant congenital cardiac syndrome
- History of HIV infection
- Known additional malignancy progressing or treated within the past year
- Active infection requiring systemic therapy
- Concurrent active hepatitis B and hepatitis C infections
- Not fully recovered from major surgery or ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 60 locations
1
Childrens Hospital Los Angeles ( Site 3006)
Los Angeles, California, United States, 90027
Actively Recruiting
2
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016)
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Yale New Haven Hospital ( Site 3012)
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Johns Hopkins All Children's Hospital ( Site 3025)
St. Petersburg, Florida, United States, 33701
Actively Recruiting
5
University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
Dana-Farber Cancer Institute ( Site 3013)
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Corewell Health ( Site 3001)
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
8
Children's Mercy Hospital ( Site 3024)
Kansas City, Missouri, United States, 64108
Actively Recruiting
9
Rutgers Cancer Institute of New Jersey ( Site 3008)
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center ( Site 3010)
New York, New York, United States, 10065
Actively Recruiting
11
New York Medical College ( Site 3023)
Valhalla, New York, United States, 10595
Actively Recruiting
12
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3003)
Fargo, North Dakota, United States, 58102
Actively Recruiting
13
Oregon Health and Science University ( Site 3004)
Portland, Oregon, United States, 97239
Actively Recruiting
14
Children's Hospital of Philadelphia (CHOP) ( Site 3021)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
Sanford Children's Hospital ( Site 3015)
Sioux Falls, South Dakota, United States, 57117
Actively Recruiting
16
University of Texas-MD Anderson Cancer Center ( Site 3007)
Houston, Texas, United States, 77030
Actively Recruiting
17
Intermountain - Primary Children's Hospital ( Site 3014)
Salt Lake City, Utah, United States, 84113
Actively Recruiting
18
Sydney Children's Hospital-Kids Cancer Centre ( Site 3997)
Sydney, New South Wales, Australia, 2031
Actively Recruiting
19
Queensland Children's Hospital ( Site 3996)
Brisbane, Queensland, Australia, 4101
Actively Recruiting
20
UZ Gent ( Site 3428)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
21
Hospital de Clinicas de Porto Alegre ( Site 3265)
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
22
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3264)
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
23
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3267)
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
24
The Hospital for Sick Children ( Site 3225)
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
25
Hospital Carlos Van Buren ( Site 3880)
Valparaíso, Valparaiso, Chile, 2341131
Actively Recruiting
26
Hospital Pablo Tobon Uribe ( Site 3923)
Medellín, Antioquia, Colombia, 05034
Actively Recruiting
27
Clinica de la Costa S.A.S. ( Site 3924)
Barranquilla, Atlántico, Colombia, 080020
Actively Recruiting
28
IMAT S.A.S ( Site 3921)
Montería, Departamento de Córdoba, Colombia, 230002
Actively Recruiting
29
Detska nemocnice FN Brno ( Site 3388)
Brno, Brno-mesto, Czechia, 613 00
Actively Recruiting
30
Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 3387)
Prague, Praha 5, Czechia, 150 00
Actively Recruiting
31
Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 3467)
Copenhagen, Capital Region, Denmark, DK-2100
Actively Recruiting
32
Bordeaux University Hospital - Pellegrin ( Site 3105)
Bordeaux, Aquitaine, France, 33076
Actively Recruiting
33
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 3102)
Marseille, Bouches-du-Rhone, France, 13005
Actively Recruiting
34
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 3104)
Nantes, Loire-Atlantique, France, 44093
Actively Recruiting
35
Centre Leon-Berard ( Site 3100)
Lyon, Rhone, France, 69373
Actively Recruiting
36
Institut Curie ( Site 3101)
Paris, Île-de-France Region, France, 75248
Actively Recruiting
37
Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 3141)
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
38
Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 3797)
Athens, Attica, Greece, 11527
Actively Recruiting
39
Semmelweis University ( Site 3838)
Budapest, Pest County, Hungary, 1094
Actively Recruiting
40
Rambam Health Care Campus ( Site 3674)
Haifa, Israel, 3109601
Actively Recruiting
41
Sheba Medical Center ( Site 3675)
Ramat Gan, Israel, 5265601
Actively Recruiting
42
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 3552)
Milan, Italy, 20133
Actively Recruiting
43
Ospedale Pediatrico Bambino Gesù IRCCS ( Site 3553)
Roma, Italy, 00165
Actively Recruiting
44
Ospedale Infantile Regina Margherita ( Site 3551)
Torino, Italy, 10126
Actively Recruiting
45
Prinses Maxima Centrum voor Kinderoncologie ( Site 3510)
Utrecht, Netherlands, 3584 CS
Actively Recruiting
46
Narodny ustav detskych chorob ( Site 3592)
Bratislava, Bratislava Region, Slovakia, 831 01
Actively Recruiting
47
Seoul National University Hospital-Pediatrics ( Site 3972)
Seoul, South Korea, 03080
Actively Recruiting
48
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 3973)
Seoul, South Korea, 05505
Actively Recruiting
49
Hospital Sant Joan de Déu ( Site 3717)
Esplugues de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
50
Hospital Universitari Vall d''Hebron ( Site 3716)
Barcelona, Spain, 08035
Actively Recruiting
51
Hospital Infantil Universitario Nino Jesus ( Site 3715)
Madrid, Spain, 28009
Actively Recruiting
52
Sahlgrenska Universitetssjukhuset ( Site 3634)
Gothenburg, Västra Götaland County, Sweden, 416 85
Actively Recruiting
53
National Taiwan University Hospital ( Site 3983)
Taiwan, Taipei, Taiwan, 10002
Actively Recruiting
54
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 3961)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
55
Ankara Bilkent Şehir Hastanesi. ( Site 3962)
Ankara, Turkey (Türkiye), 6800
Actively Recruiting
56
Ege Universitesi Hastanesi ( Site 3963)
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
57
Birmingham Children's Hospital ( Site 3349)
Birmingham, England, United Kingdom, B4 6NH
Actively Recruiting
58
Royal Victoria Infirmary ( Site 3348)
Newcastle upon Tyne, England, United Kingdom, NE1 4PL
Actively Recruiting
59
University Hospital of Wales ( Site 3346)
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
60
Royal Marsden Hospital ( Site 3347)
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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