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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.

Belong to the Master protocol, LIGHTBEAM-U01 Master Protocol: A Phase 1/2 Platform Study to Evaluate the Safety and Efficacy of Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors

Substudy 01A Primary objectives:

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.

Protocol Number: 112401-01A
Phase: Phase I/II
Applicable Disease Sites: Any Site
Drugs Involved: Zilovertamab Vedotin
Principal Investigator: Richard A Drachtman
Scope: National
Therapies Involved: 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.

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