Clinical Trial

Phase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed/Refractory or Metastatic Solid Tumors

Study acronym: MRG003
Recruiting Phase 1
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Summary
There is a significant unmet medical need for effective therapies for pediatric relapsed/refractory solid tumors. EGFR is highly and stably expressed in multiple pediatric solid tumor subtypes, and adult Phase I data of Becotatug Vedotin demonstrated a manageable safety profile and promising antitumor activity in EGFR-positive advanced solid tumors.This is a multicenter, non-randomized, single-arm, open-label Phase I clinical trial sponsored by Sun Yat-sen University Cancer Center (SYSUCC). The trial evaluates the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of Becotatug Vedotin-an EGFR-targeted antibody-drug conjugate (ADC)-in pediatric patients with EGFR-positive relapsed/refractory or metastatic solid tumors.
Trial Details
NCT Number NCT07584499
Lead Sponsor Sun Yat-sen University
Conditions Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Nasopharyngeal Carcinoma, Lymphoepithelial Carcinoma, Rhabdomyosarcoma, Neuroblastoma, Medulloblastoma, Wilms Tumor, Atypical Teratoid/Rhabdoid Tumors +2 more
Enrollment 51 participants
Start Date 2026-05-30
Primary Completion 2027-05-30 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-13