NCT05075564

A Study of ES002023 (Anti-CD39 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors

An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Phase 1 Study of ES002023 in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Elpiscience Biopharma, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Part 1 ES002023	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.
DRUG	Part 2 ES002023	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.

Timeline

• Start date: 2021-12-23
• Primary completion: 2022-10-13
• Completion: 2022-10-13
• First posted: 2021-10-13
• Last updated: 2025-05-14

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study