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KN046 in Subjects With Late Stage Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:
A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Clinical Trial Summary

This is an open-label, multi-center, single arm study to evaluate the efficacy, safety and tolerability of KN046 in subjects with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC). The study is composed of 3 stages. Stage 1 (Safety run-in period) will enroll approximately 6 subjects with KN046 3 mg/kg Q2W IV, for at least 4 cycles; thereafter, Scientific Monitoring Committee (SMC) will held to review the safety profiling data and decide whether proceed to stage 2 (Expansion period). Stage 2 will enroll up to 30 subjects. After completion of the enrollment from Stage 2 and all subjects have completed at least two post baseline tumor evaluation, an interim analysis will be performed for efficacy evaluation. SMC will continuously review the safety and clinical efficacy during the study and at the interim analysis and be responsible for the decision of proceeding to Stage 3 (Biomarker enrich period).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03925870
Study type Interventional
Source Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Contact
Status Completed
Phase Phase 2
Start date June 21, 2019
Completion date July 4, 2022
View Details
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