The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ES009 administered intravenously to subjects with advanced solid tumors.
ES009 is a recombinant humanized IgG4 monoclonal antibody that specifically targets and blocks LILRB2. By reprograming suppressive myeloid cells into pro-inflammatory phenotypes, ES009 reshapes the immunosuppressive tumor microenvironment into an immune-favorable one to combat cancer development and progression. This is a 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 ES009 by evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ES009 administered intravenously to subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
ES009 is administered via intravenous infusion, once every 21 days.
Peninsula and South Eastern Oncology and Haematology Group
Frankston, Australia
St George Private Hospital
Kogarah, Australia
Scientia Clinical Research
Randwick, Australia
Sunshine Coast University Private Hospital
Sunshine Coast, Australia
The frequency and severity of adverse events of ES009
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
Maximum tolerated dose (MTD) of ES009
The MTD of ES009 will be determined.
Time frame: 1-3 years
Optimal biological dose (OBD) of ES009
The OBD of ES009 will be determined.
Time frame: 1-3 years
Recommended phase 2 dose (RP2D) of ES009
The RP2D of ES009 will be determined.
Time frame: 1-3 years
Maximum administered dose (MAD) of ES009
The MAD of ES009 will be determined.
Time frame: 1-3 years
Maximum observed serum concentration (Cmax) of ES009
Maximum observed serum concentration (Cmax) of ES009 will be measured.
Time frame: 1-3 years
Trough observed serum concentration (Ctrough) of ES009
Trough observed serum concentration (Ctrough)of ES009 will be measured.
Time frame: 1-3 years
Area under the serum concentration time curve (AUC) of ES009
Area under the serum concentration time curve (AUC) of ES009 will be measured.
Time frame: 1-3 years
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Time to Cmax (Tmax) of ES009
Time to Cmax (Tmax) of ES009 will be measured.
Time frame: 1-3 years
The terminal elimination half life of ES009
The terminal elimination half-life (t 1/2) of ES009 will be measured.
Time frame: 1-3 years
Immunogenicity of ES009
Frequency of anti-drug antibodies (ADA) against ES009 will be determined.
Time frame: 1-3 years
Preliminary antitumor activity of ES009
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