drugset / Trial / NCT07697040

Becotatug Vedotin Plus Cisplatin and Radiotherapy in LA-ESCC

NCT07697040

Phase 1 Not yet recruiting 12 enrolled Hebei Medical University Fourth Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study is a prospective, single-arm, single-center Phase Ib clinical trial of Becotatug Vedotin in combination with cisplatin and concurrent radiotherapy for locally advanced esophageal squamous cell carcinoma. The primary objectives are to investigate the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and recommended Phase II dose (RP2D) of Becotatug Vedotin in combination with cisplatin and concurrent radiotherapy for locally advanced esophageal squamous cell carcinoma. The secondary objectives are to assess the efficacy and safety of this combination regimen.

Timeline

Start
2026-07-01
Primary completion
2029-07-01
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Becotatug Vedotin Monoclonal antibody 1.5 mg/kg Intravenous
Subject Becotatug Vedotin Monoclonal antibody 2 mg/kg Intravenous
Subject Becotatug Vedotin Monoclonal antibody 2.3 mg/kg Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous