NCT06395103PHASE1, PHASE2RECRUITING

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

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

Sponsor: Merck Sharp & Dohme LLC

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

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

Interventions

Zilovertamab vedotin

Enrollment

90 participants

Primary completion

Mar 2029

Study completion

Mar 2029

First posted

May 2024

Last updated

May 2026

Primary Endpoints (CT.gov)

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

Secondary Endpoints

Part 1 and Part 2: Area Under the Curve (AUC) of Total Antibody

Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Total Antibody

Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Total Antibody

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 star…

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov