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

NCT07584499 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-05-13

No results posted yet for this study

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.

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
  • Diffuse Intrinsic Pontine Gliomas
  • Other EGFR-positive Pediatric Solid Tumors Deemed Eligible by the Investigator

Interventions

DRUG

Becotatug Vedotin

Study Drug: Becotatug Vedotin (MRG003) for Injection (lyophilized powder, 20 mg/vial) Route: Intravenous (IV) infusion over 30 minutes to 3 hours Schedule: Every 3 weeks (Q3W) on Day 1 of each 21-day cycle Maximum Treatment Duration: Up to 8 cycles (24 weeks); patients with confirmed clinical benefit (objective response or stable disease) may continue treatment beyond 8 cycles until disease progression, unacceptable toxicity, withdrawal of consent, or study termination

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2027-05-30
Completion
2028-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584499 on ClinicalTrials.gov