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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07630974
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
1 Month - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Ifinatamab Deruxtecan — BIOLOGICAL
    IV infusion

Study Details

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

Key Dates

First listed
Jun 5, 2026
Start date
Jul 6, 2026
Status verified
Sep 2026
Primary completion
Aug 17, 2031
Completion
Aug 17, 2031

Study Design

Enrollment
134 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ifinatamab Deruxtecan
    Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression

Primary Outcome Measure

Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT) [ Time Frame: Cycle 1 (up to approximately 21 days); each cycle is 21 days ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Children's Hospital Los Angeles ( Site 4006)Los AngelesCalifornia90027
Study Coordinator
323-361-2121
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)AuroraColorado80045
Study Coordinator
720-777-6740
University of Iowa Hospitals ( Site 4017)Iowa CityIowa52242
Study Coordinator
319-356-2296
Dana Farber Cancer Center ( Site 4013)BostonMassachusetts02215
Study Coordinator
617-632-4580
Corewell Health ( Site 4001)Grand RapidsMichigan49503
Study Coordinator
616-486-0746
Rutgers Cancer Institute of New Jersey ( Site 4008)New BrunswickNew Jersey08901
Study Coordinator
732-235-2465
Memorial Sloan Kettering Cancer Center ( Site 4010)New YorkNew York10065
Study Coordinator
888-492-8401
New York Medical College ( Site 4023)ValhallaNew York10595
Study Coordinator
914-614-4270
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003)FargoNorth Dakota58102
Study Coordinator
701-234-2000
Children's Hospital of Philadelphia (CHOP) ( Site 4021)PhiladelphiaPennsylvania19104
Study Coordinator
267-425-5544
Sanford Children's Hospital ( Site 4015)Sioux FallsSouth Dakota57105
Study Coordinator
605-312-1000
University of Texas M.D. Anderson Cancer Center ( Site 4007)HoustonTexas77030
Study Coordinator
713-792-5410
Intermountain - Primary Children's Hospital ( Site 4014)Salt Lake CityUtah84113
Study Coordinator
801-662-4700

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By research site
Children's Hospital Los Angeles· Los Angeles, CAChildren's Hospital Colorado-Center for Cancer and Blood Disorders· Aurora, COUniversity of Iowa Hospitals· Iowa City, IADana Farber Cancer Center· Boston, MACorewell Health· Grand Rapids, MIRutgers Cancer Institute of New Jersey· New Brunswick, NJ

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