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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06941272
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

  • Patritumab Deruxtecan — BIOLOGICAL
    IV Infusion

Study Details

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

Key Dates

Start date
May 26, 2025
Status verified
May 2026
Primary completion
Dec 30, 2030
Completion
Dec 30, 2030

Study Design

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

Arms

  • Experimental: Patritumab Deruxtecan
    Participants receive patritumab deruxtecan via IV infusion on Day 1 of each 3-week cycle until discontinuation or progression.

Primary Outcome Measure

Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (up to approximately 21 days); each cycle is 21 days ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Childrens Hospital Los Angeles ( Site 3006)Los AngelesCalifornia90027
Study Coordinator
323-361-2121
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016)AuroraColorado80045
Study Coordinator
720-777-1234
Yale New Haven Hospital ( Site 3012)New HavenConnecticut06510
Study Coordinator
203-785-4640
Johns Hopkins All Children's Hospital ( Site 3025)St. PetersburgFlorida33701
Study Coordinator
727-767-4176
University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)Iowa CityIowa52242
Study Coordinator
319-356-2296
Dana-Farber Cancer Institute ( Site 3013)BostonMassachusetts02215
Study Coordinator
617-632-4580
Corewell Health ( Site 3001)Grand RapidsMichigan49503
Study Coordinator
616-486-0746
Children's Mercy Hospital ( Site 3024)Kansas CityMissouri64108
Study Coordinator
816-302-6808
Rutgers Cancer Institute of New Jersey ( Site 3008)New BrunswickNew Jersey08901
Study Coordinator
732-235-2465
Memorial Sloan Kettering Cancer Center ( Site 3010)New YorkNew York10065
Study Coordinator
888-492-8401
New York Medical College ( Site 3023)ValhallaNew York10595
Study Coordinator
914-614-4270
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3003)FargoNorth Dakota58102
Study Coordinator
701-234-2000
Oregon Health and Science University ( Site 3004)PortlandOregon97239
Study Coordinator
503-494-8311
Children's Hospital of Philadelphia (CHOP) ( Site 3021)PhiladelphiaPennsylvania19104
Study Coordinator
267-425-5544
Sanford Children's Hospital ( Site 3015)Sioux FallsSouth Dakota57117
Study Coordinator
605-312-1000
University of Texas-MD Anderson Cancer Center ( Site 3007)HoustonTexas77030
Study Coordinator
713-792-5410
Intermountain - Primary Children's Hospital ( Site 3014)Salt Lake CityUtah84113
Study Coordinator
801-662-4700

Find similar trials in Los Angeles, CA

By research site
Childrens Hospital Los Angeles· Los Angeles, CAChildren's Hospital Colorado-Center for Cancer and Blood Disorders· Aurora, COYale New Haven Hospital· New Haven, CTJohns Hopkins All Children's Hospital· St. Petersburg, FLUniversity of Iowa Health Care Holden Comprehensive Cancer Center· Iowa City, IADana-Farber Cancer Institute· Boston, MA

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