RecruitingPhase 1Phase 2NCT07630974

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

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors


Sponsor

Merck Sharp & Dohme LLC

Enrollment

134 participants

Start Date

Jul 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Researchers are looking for new ways to treat children with relapsed or refractory solid tumors: * Relapsed means the cancer came back after treatment * Refractory means the cancer did not respond (get smaller or go away) to treatment * Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids The study treatment I-DXd (also known as MK-2400 or ifinatamab 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 I-DXd and if children younger than 12 years old tolerate it * How many children who receive I-DXd have the cancer get smaller or go away


Eligibility

Min Age: 1 MonthMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Ifinatamab Deruxtecan for people with malignant neoplasm. The study is currently recruiting participants at 14 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIfinatamab Deruxtecan

IV infusion


Locations(17)

University of Iowa Hospitals ( Site 4017)

Iowa City, Iowa, United States

Dana Farber Cancer Center ( Site 4013)

Boston, Massachusetts, United States

Rutgers Cancer Institute of New Jersey ( Site 4008)

New Brunswick, New Jersey, United States

Memorial Sloan Kettering Cancer Center ( Site 4010)

New York, New York, United States

New York Medical College ( Site 4023)

Valhalla, New York, United States

Children's Hospital of Philadelphia (CHOP) ( Site 4021)

Philadelphia, Pennsylvania, United States

Intermountain - Primary Children's Hospital ( Site 4014)

Salt Lake City, Utah, United States

UZ Gent ( Site 4428)

Ghent, Oost-Vlaanderen, Belgium

Rigshospitalet ( Site 4467)

Copenhagen, Capital Region, Denmark

CENTRE LEON BERARD ( Site 4100)

Lyon, Rhone, France

Rambam Health Care Campus ( Site 4674)

Haifa, Israel

Seoul National University Hospital-Pediatrics ( Site 4972)

Seoul, South Korea

Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973)

Seoul, South Korea

Hospital Sant Joan de Déu ( Site 4717)

Esplugues de Llobregat, Barcelona, Spain

Hospital Niño Jesús ( Site 4715)

Madrid, Madrid, Comunidad de, Spain

Hospital Universitari Vall d Hebron ( Site 4716)

Barcelona, Spain

Sahlgrenska Universitetssjukhuset ( Site 4634)

Gothenburg, Västra Götaland County, Sweden

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NCT07630974


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