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

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 eff

Trial Details

NCT ID
NCT07584499
Phase
PHASE1
Sponsor
Sun Yat-sen University
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Becotatug Vedotin
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • All participants must meet all of the following criteria to be eligible for enrollment:
  • Informed Consent: The patient (and/or legal guardian, as age-appropriate) fully understands the study, voluntarily agrees to participate, and signs…
  • Age: 2 to 18 years old at the time of consent. Life Expectancy: Estimated overall survival of at least 3 months.
  • Histologically Confirmed Disease: Pathologically confirmed relapsed/refractory or metastatic EGFR-positive solid tumor, belonging to one of the fol…

For full eligibility, visit ClinicalTrials.gov.

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