Recruiting

Phase 1

Phase 2

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06395103

Conditions

B-cell Acute Lymphoblastic Leukemia

Diffuse Large B-cell Lymphoma

Burkitt Lymphoma

Neuroblastoma

Ewing Sarcoma

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Interventions

Zilovertamab vedotin

Study Details

Brief summary:

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.

Conditions

B-cell Acute Lymphoblastic Leukemia

Diffuse Large B-cell Lymphoma

Burkitt Lymphoma

Neuroblastoma

Ewing Sarcoma

Study ID

NCT06395103

Start date

Aug 16, 2024

Status verified date

Sep, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues.
For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma.

Exclusion Criteria:

History of solid organ transplant.
Clinically significant (ie, active) cardiovascular disease.
Known history of liver cirrhosis.
Ongoing Grade >1 peripheral neuropathy.
Demyelinating form of Charcot-Marie-Tooth disease.
Diagnosed with Down syndrome.
Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.
History of human immunodeficiency virus (HIV) infection.
Contraindication or hypersensitivity to any of the study intervention components.
Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.
Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1).
Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention
Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
Known additional malignancy that is progressing or has required active treatment within the past 1 year.
Active infection requiring systemic therapy.
Known history of Hepatitis B or known active Hepatitis C virus infection.
Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Zilovertamab vedotin

Administered via IV infusion

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 ]
Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 54 months ]
Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs [ Time Frame: Up to approximately 54 months ]
Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs [ Time Frame: Up to approximately 54 months ]
Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL) [ Time Frame: Up to approximately 54 months ]
Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma [ Time Frame: Up to approximately 54 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Children's Hospital Los Angeles ( Site 1006)

Recruiting

Los Angeles, California, United States, 90027

Contacts

Study Coordinator

323-361-2121

Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

720-777-1234

Yale New Haven Hospital ( Site 1012)

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Study Coordinator

203-785-4640

Johns Hopkins All Children's Hospital ( Site 1025)

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Study Coordinator

727-767-4176

University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Study Coordinator

319-356-2296

Dana-Farber Cancer Institute ( Site 1013)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

617-632-4580

Corewell Health ( Site 1001)

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Study Coordinator

616-486-0746

Children's Mercy Hospital ( Site 1024)

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Study Coordinator

816-302-6808

Rutgers Cancer Institute of New Jersey ( Site 1008)

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Study Coordinator

732-235-2465

Memorial Sloan Kettering Cancer Center ( Site 1010)

Recruiting

New York, New York, United States, 10065

Contacts

Study Coordinator

888-492-8401

New York Medical College ( Site 1023)

Recruiting

Valhalla, New York, United States, 10595

Contacts

Study Coordinator

914-614-4270

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)

Recruiting

Fargo, North Dakota, United States, 58102

Contacts

Study Coordinator

701-234-2000

Oregon Health and Science University ( Site 1004)

Recruiting

Portland, Oregon, United States, 97239

Contacts

Study Coordinator

503-494-8311

Children's Hospital of Philadelphia (CHOP) ( Site 1021)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

267-425-5544

Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Study Coordinator

605-312-1000

University of Texas MD Anderson Cancer Center ( Site 1007)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-792-5410

Intermountain - Primary Children's Hospital ( Site 1014)

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Study Coordinator

801-662-4700

Alberta Children's Hospital ( Site 1227)

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Study Coordinator

403-955-7211

The Hospital for Sick Children ( Site 1225)

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Study Coordinator

416-813-1500

McGill University Health Centre-Pediatric HematologyOncology ( Site 1223)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Study Coordinator

514-412-4445

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.