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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

Primary:
Part 1: To evaluate the safety and tolerability of zilovertamab vedotin monotherapy in participants from 1 to <18 years of age
Part 1 and Part 2: To evaluate preliminary antitumor activity of zilovertamab vedotin monotherapy per investigator assessment in participants from birth to <18 years of age for B-ALL, DLBCL/Burkitt lymphoma, and neuroblastoma, and from birth to 25 years for Ewing sarcoma

Secondary Objectives:
Part 1 and Part 2: To determine PK profile of zilovertamab vedotin
Part 2: To evaluate the safety and tolerability of zilovertamab vedotin monotherapy in participants from birth to <18 years (B-ALL, DLBCL/Burkitt lymphoma, and neuroblastoma), and from birth to 25 years for Ewing sarcoma
Part 1 and Part 2: To assess the immunogenicity potential of zilovertamab vedotin
Part 1 and Part 2: To evaluate DOR per investigator assessment by tumor type
Part 1 and Part 2: To evaluate the proportion of participants by tumor type
who become eligible for transplant/CAR-T while on treatment with zilovertamab vedotin

Protocol Number: 112401
Phase: Phase I/II
Applicable Disease Sites: Any Site
Drugs Involved: Favezelimab (MK4280A)
Pembrolizumab (MK-3475)
Vibostolimab
Zilovertamab Vedotin
Principal Investigator: Richard A Drachtman
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.