The purpose of this first-in-human, open-label, multicenter, non-randomized study is to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary clinical activity of ES002023 in patients with advanced solid tumors that are relapsed or refractory to standard therapies.
ES002023 is a recombinant humanized IgG1 monoclonal antibody (mAb) that specifically targets the human ectonucleoside triphosphate diphosphohydrolase-1 (ENTPD1, CD39, UniprotKB: P49961). ES002023 is generated using classic hybridoma technology with an attenuated effector domain (Fc) based on human IgG1. ES002023 binding to CD39 inhibits the enzyme activity of ectonucleoside triphosphate diphosphohydrolase, which can result in the stabilization of pro-inflammatory extracellular ATP (eATP) and the restoration of antitumor immunity by impairing the accumulation of immune suppressive adenosine within the tumor microenvironment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
ES002023 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.
ES002023 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.
HonorHealth
Scottsdale, Arizona, United States
Fayetteville Oncology
Fayetteville, Arkansas, United States
UCLA
Los Angeles, California, United States
Sarah Cannon Research Institute
Orlando, Florida, United States
The frequency and severity of adverse events of ES002023
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
The Maximum Tolerated Dose (MTD), Optimal Biological Dose (OBD) and/or the Recommended Phase 2 Dose (RP2D) of ES002023
The MTD, OBD and/or RP2D of ES002023 will be determined
Time frame: 1-3 years
Maximum observed serum concentration (Cmax) of ES002023
Maximum observed serum concentration (Cmax) of ES002023 will be measured.
Time frame: 1-3 years
Trough observed serum concentration (Ctrough) of ES002023
Trough observed serum concentration (Ctrough)of ES002023 will be measured.
Time frame: 1-3 years
Area under the serum concentration time curve (AUC) of ES002023
Area under the serum concentration time curve (AUC) of ES002023 will be measured.
Time frame: 1-3 years
Time to Cmax (Tmax) of ES002023
Time to Cmax (Tmax) of ES002023 will be measured.
Time frame: 1-3 years
The terminal elimination half life of ES002023
The terminal elimination half-life (t 1/2) of ES002023 will be measured.
Time frame: 1-3 years
The clearance of ES002023
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
NEXT Austin
Austin, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
A pharmacokinetic measurement of the volume of plasma from which ES002023 is completely removed per unit time.
Time frame: 1-3 years
The volume of distribution of ES002023
The amount of of ES002023 in the body divided by the plasma concentration will be measured.
Time frame: 1-3 years
The immunogenicity of ES002023
The presence and the frequency of anti-drug antibodies (ADA) against ES002023 will be measured.
Time frame: 1-3 years
The antitumor activity of ES002023
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