Phase I Study of Becotatug Vedotin to Assess Safety and Effectiveness in Children Aged 2 to 18 With EGFR-Positive Relapsed or Metastatic Solid Tumors

What this Trial Is About

Pediatric patients with relapsed or refractory solid tumors, especially those that are EGFR-positive, face limited treatment options and significant medical needs. Researchers are evaluating Becotatug Vedotin, an antibody-drug conjugate targeting EGFR, to understand its safety, tolerability, pharmacokinetics, immune response, and initial effectiveness in this vulnerable population. This Phase I clinical trial builds on adult studies showing manageable safety and promising tumor response in similar cancers. All participants in this open-label, single-arm trial receive Becotatug Vedotin through intravenous infusion every three weeks. The treatment lasts up to eight cycles 24 weeks, with the possibility to continue if clinical benefit is observed. The trial begins with a dose-escalation phase to find the recommended dose, followed by a dose-expansion phase where all patients receive this dose. Participants will undergo evaluations including tumor imaging by CT or MRI to measure response, safety assessments to monitor for dose-limiting toxicities especially during the first treatment cycle, and laboratory tests for blood and organ function. The study carefully monitors patients for side effects and treatment impact over the course of therapy, with the total participation lasting up to 24 weeks or longer if treatment continues beyond the initial cycles.

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