KN046 in Subjects With Late Stage Esophageal Squamous Cell Carcinoma
Status:
Recruiting
Trial end date:
2021-05-15
Target enrollment:
Participant gender:
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).