A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
NCT ID: NCT06941272
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2025-05-26
2030-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patritumab Deruxtecan
Participants receive patritumab deruxtecan via IV infusion on Day 1 of each 3-week cycle until discontinuation or progression.
Patritumab Deruxtecan
IV Infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Patritumab Deruxtecan
IV Infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
1 Month
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daiichi Sankyo
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016)
Aurora, Colorado, United States
University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)
Iowa City, Iowa, 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
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
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
UZ Gent ( Site 3428)
Ghent, Oost-Vlaanderen, Belgium
Bordeaux University Hospital - Pellegrin ( Site 3105)
Bordeaux, Aquitaine, 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
Rambam Health Care Campus ( Site 3674)
Haifa, , Israel
Sheba Medical Center ( Site 3675)
Ramat Gan, , Israel
Prinses Maxima Centrum voor Kinderoncologie ( Site 3510)
Utrecht, , Netherlands
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
Royal Victoria Infirmary ( Site 3348)
Newcastle upon Tyne, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MK-9999-01C
Identifier Type: OTHER
Identifier Source: secondary_id
LIGHTBEAM-U01
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1314-1866
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-518771-66-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
9999-01C
Identifier Type: -
Identifier Source: org_study_id