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

Recruiting now · Phase 1/Phase 2

Conditions studied: B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma, Burkitt Lymphoma, Neuroblastoma, Ewing Sarcoma

In brief

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 facts

Study ID: NCT06395103
Run by: Merck Sharp & Dohme LLC
People needed: 90
Starts: 2024-08-16
Expected to finish: 2029-03-31
Last updated by the study team: 2026-07-27

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Children's Hospital Los Angeles ( Site 1006) — Los Angeles, California, United States (enrolling)
Yale New Haven Hospital ( Site 1012) — New Haven, Connecticut, United States (enrolling)
Johns Hopkins All Children's Hospital ( Site 1025) — St. Petersburg, Florida, United States (enrolling)
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016) — Aurora, Colorado, United States (enrolling)
Dana-Farber Cancer Institute ( Site 1013) — Boston, Massachusetts, United States (enrolling)
Corewell Health ( Site 1001) — Grand Rapids, Michigan, United States (enrolling)
Children's Mercy Hospital ( Site 1024) — Kansas City, Missouri, United States (enrolling)
Rutgers Cancer Institute of New Jersey ( Site 1008) — New Brunswick, New Jersey, United States (enrolling)
Memorial Sloan Kettering Cancer Center ( Site 1010) — New York, New York, United States (enrolling)
University of Iowa-Holden Comprehensive Cancer Center ( Site 1017) — Iowa City, Iowa, United States (enrolling)
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003) — Fargo, North Dakota, United States (enrolling)
Oregon Health and Science University ( Site 1004) — Portland, Oregon, United States (enrolling)
Children's Hospital of Philadelphia (CHOP) ( Site 1021) — Philadelphia, Pennsylvania, United States (enrolling)
Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015) — Sioux Falls, South Dakota, United States (enrolling)
University of Texas MD Anderson Cancer Center ( Site 1007) — Houston, Texas, United States (enrolling)
Intermountain - Primary Children's Hospital ( Site 1014) — Salt Lake City, Utah, United States (enrolling)
Sydney Children's Hospital ( Site 1997) — Randwick, New South Wales, Australia (enrolling)
Queensland Children's Hospital-Oncology & Haematology ( Site 1996) — Brisbane, Queensland, Australia (enrolling)
Royal Children's Hospital-Children's Cancer Centre ( Site 1994) — Melbourne, Victoria, Australia (enrolling)
UZ Gent ( Site 1428) — Ghent, Oost-Vlaanderen, Belgium (enrolling)
New York Medical College ( Site 1023) — Valhalla, New York, United States (enrolling)
Hospital de Clinicas de Porto Alegre ( Site 1265) — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1264) — Barretos, São Paulo, Brazil (enrolling)
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1267) — São José do Rio Preto, São Paulo, Brazil (enrolling)
Alberta Children's Hospital ( Site 1227) — Calgary, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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