Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06395103
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Zilovertamab vedotin — BIOLOGICAL
    Administered via IV infusion

Study Details

Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)/Burkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.

Key Dates

Start date
Aug 16, 2024
Status verified
Jun 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

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

Arms

  • Experimental: Zilovertamab vedotin
    Participants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).

Primary Outcome Measure

Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 42 days ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Children's Hospital Los Angeles ( Site 1006)Los AngelesCalifornia90027
Study Coordinator
323-361-2121
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)AuroraColorado80045
Study Coordinator
720-777-1234
Yale New Haven Hospital ( Site 1012)New HavenConnecticut06510
Study Coordinator
203-785-4640
Johns Hopkins All Children's Hospital ( Site 1025)St. PetersburgFlorida33701
Study Coordinator
727-767-4176
University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)Iowa CityIowa52242
Study Coordinator
319-356-2296
Dana-Farber Cancer Institute ( Site 1013)BostonMassachusetts02215
Study Coordinator
617-632-4580
Corewell Health ( Site 1001)Grand RapidsMichigan49503
Study Coordinator
616-486-0746
Children's Mercy Hospital ( Site 1024)Kansas CityMissouri64108
Study Coordinator
816-302-6808
Rutgers Cancer Institute of New Jersey ( Site 1008)New BrunswickNew Jersey08903
Study Coordinator
732-235-2465
Memorial Sloan Kettering Cancer Center ( Site 1010)New YorkNew York10065
Study Coordinator
888-492-8401
New York Medical College ( Site 1023)ValhallaNew York10595
Study Coordinator
914-614-4270
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)FargoNorth Dakota58102
Study Coordinator
701-234-2000
Oregon Health and Science University ( Site 1004)PortlandOregon97239
Study Coordinator
503-494-8311
Children's Hospital of Philadelphia (CHOP) ( Site 1021)PhiladelphiaPennsylvania19104
Study Coordinator
267-425-5544
Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)Sioux FallsSouth Dakota57105
Study Coordinator
605-312-1000
University of Texas MD Anderson Cancer Center ( Site 1007)HoustonTexas77030
Study Coordinator
713-792-5410
Intermountain - Primary Children's Hospital ( Site 1014)Salt Lake CityUtah84113
Study Coordinator
801-662-4700

Find similar trials in Los Angeles, CA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Children's 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-Holden Comprehensive Cancer Center· Iowa City, IADana-Farber Cancer Institute· Boston, MA

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