The purpose of this open-label, Multicenter Phase I/II study is to evaluate the safety, tolerability, preliminary anti-tumor efficay, pharmacokinetics, anti-drug antibodies and biomarkers of ES104 in patients with unresectable locally advanced or metastatic colorectal cancer who have failed systemic therapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
ES104 is administered via Intravenous infusion, at dose of 10 mg/kg, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.
ES104 is administered via Intravenous infusion, at dose of 12.5 mg/kg, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.
ES104 is administered via Intravenous infusion, at dose of RP2D, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.
Beijing Cancer Hospital
Beijing, China
Phase 1: The frequency and severity of adverse events of ES104
The safety profile of ES104 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time frame: 1-3 years
Phase 2: The anti-tumor activity of ES104
The Objective Remission Rate (ORR) will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.
Time frame: 2-5 years
Phase 1: Maximum observed serum concentration (Cmax) of ES104
Maximum observed serum concentration (Cmax) of ES104 will be measured.
Time frame: 1-3 years
Phase 1:Time to Cmax (Tmax) of ES104
Time to Cmax (Tmax) of ES104 will be measured.
Time frame: 1-3 years
Phase 1:Area under the serum concentration time curve (AUC) of ES104
Area under the serum concentration time curve (AUC) of ES104 will be measured.
Time frame: 1-3 years
Phase 1:The clearance of ES104
A pharmacokinetic measurement of the volume of plasma from which ES104 is completely removed per unit time.
Time frame: 1-3 years
Phase 1: The immunogenicity of ES104
The presence and the frequency of anti-drug antibodies (ADA) against ES104 will be measured.
Time frame: 1-3 years
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Phase 1: The preliminary anti-tumor activity of ES104
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
Phase 2: The anti-tumor activity of ES104
Tumor response will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.
Time frame: 2-5 years
Phase 2: The frequency and severity of adverse events of ES104
The safety profile of ES104 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time frame: 2-5 years
Phase 2: The popPK profile of ES104
The Cmin,ss、CL and Vd of ES104 will be measured.
Time frame: 2-5 years
Phase 2: The immunogenicity of ES104
The presence and the frequency of anti-drug antibodies (ADA) against ES104 will be measured.
Time frame: 2-5 years