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

RecruitingPhase 1/2

LIGHTBEAM-U01 Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors

Who can join

6 Months – 25 Years · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 90 · Started: Aug 16, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06395103

Locations in the U.S.

CaliforniaChildren's Hospital Los Angeles ( Site 1006), Los Angeles
ColoradoChildren's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016), Aurora
ConnecticutYale New Haven Hospital ( Site 1012), New Haven
FloridaJohns Hopkins All Children's Hospital ( Site 1025), St. Petersburg
IowaUniversity of Iowa-Holden Comprehensive Cancer Center ( Site 1017), Iowa City
MassachusettsDana-Farber Cancer Institute ( Site 1013), Boston
MichiganCorewell Health ( Site 1001), Grand Rapids
MissouriChildren's Mercy Hospital ( Site 1024), Kansas City
New JerseyRutgers Cancer Institute of New Jersey ( Site 1008), New Brunswick
New YorkMemorial Sloan Kettering Cancer Center ( Site 1010), New York
New York Medical College ( Site 1023), Valhalla
North DakotaSanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003), Fargo
OregonOregon Health and Science University ( Site 1004), Portland
PennsylvaniaChildren's Hospital of Philadelphia (CHOP) ( Site 1021), Philadelphia
South DakotaSanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015), Sioux Falls
TexasUniversity of Texas MD Anderson Cancer Center ( Site 1007), Houston
UtahIntermountain - Primary Children's Hospital ( Site 1014), Salt Lake City

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.