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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Eligible subjects will be enrolled and receive KN046 (3 mg/kg) monotherapy treatment until progressive disease according to RECIST 1.1, unacceptable toxicity, completion of 2 years' KN046 treatment, or withdrawal of informed consent, whichever comes first
307 Hospital of PLA
Beijing, Beijing Municipality, China
Objective response (OR)
Objective response (OR) per RECIST 1.1 criteria according to investigators assessment;
Time frame: up to 2 years
Duration of response (DOR)
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment;
Time frame: up to 2 years
Clinical benefit rate
Clinical benefit rate
Time frame: up to 2 years
Progression free survival (PFS) rates
Progression free survival (PFS) rates
Time frame: 6 months and 12 months
Overall survival (OS) rates
Overall survival (OS) rates
Time frame: 6 months and 12 months
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