The purpose of this first-in-human, open-label, multicenter, non-randomized study designed to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD), optimal biological dose (OBD), and recommended phase 2 dose (RP2D) of ES014 by evaluating the safety, tolerability, PK, pharmacodynamics, and preliminary clinical activity of ES014 administered intravenously to subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
ES014 is administered via intravenous infusion, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.
Shanghai Chest Hospital
Shanghai, China
The frequency and severity of adverse events of ES014
Adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time frame: 1-3 years
Dose Limiting Toxicity of ES014
Evaluation of dose-limiting toxicity (DLT)
Time frame: 1-3 years
Maximum observed serum concentration (Cmax) of ES014
Maximum observed serum concentration (Cmax) of ES014 will be measured.
Time frame: 1-3 years
Trough observed serum concentration (Ctrough) of ES014
Trough observed serum concentration (Ctrough)of ES014 will be measured.
Time frame: 1-3 years
Area under the serum concentration time curve (AUC) of ES014
Area under the serum concentration time curve (AUC) of ES014 will be measured.
Time frame: 1-3 years
Time to Cmax (Tmax) of ES014
Time to Cmax (Tmax) of ES014 will be measured.
Time frame: 1-3 years
The terminal elimination half life of ES014
The terminal elimination half-life (t 1/2) of ES014 will be measured.
Time frame: 1-3 years
The clearance of ES014
A pharmacokinetic measurement of the volume of plasma from which ES014 is completely removed per unit time.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1-3 years
The volume of distribution of ES014
The amount of of ES014 in the body divided by the plasma concentration will be measured.
Time frame: 1-3 years
The immunogenicity of ES014
The presence and the frequency of anti-drug antibodies (ADA) against ES014 will be measured.
Time frame: 1-3 years
The antitumor activity of ES014
Tumor response will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.
Time frame: 1-3 years