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

NCT05075564 | Completed Phase 1 FDA Drug

• 1 other identifier: ES002023-1001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  1-3 years

Secondary Outcomes (9)

• Maximum observed serum concentration (Cmax) of ES002023

  1-3 years

• Trough observed serum concentration (Ctrough) of ES002023

  1-3 years

• Area under the serum concentration time curve (AUC) of ES002023

  1-3 years

• Time to Cmax (Tmax) of ES002023

  1-3 years

• The terminal elimination half life of ES002023

  1-3 years

Study Arms (2)

Part 1 dose escalation

EXPERIMENTAL

ES002023 doses will be escalated in patients with advanced solid tumors with approximately 30 subjects.

Drug: Part 1 ES002023

Part 2 dose expansion

EXPERIMENTAL

Part 2 of the study will consist of 3 expansion cohorts for pancreatic ductal adenocarcinoma (Cohort 2A), NSCLC (Cohort 2B), and colorectal adenocarcinoma (Cohort 2C) with 10 subjects per expansion cohort respectively at the recommended optimal biological dose determined in Part 1 dose escalation.

Drug: Part 2 ES002023

Interventions

Part 1 ES002023 DRUG

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.

Part 1 dose escalation

Part 2 ES002023 DRUG

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.

Part 2 dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of giving signed informed consent.
• Part 1: Histological or cytological documentation of unresectable locally advanced or metastatic solid tumors, if 1) disease has progressed despite standard therapy, and no further standard therapy exists; or 2) standard therapy has proven to be ineffective, intolerable, or is considered inappropriate.
• Part 2: Histological or cytological documentation of pancreatic ductal adenocarcinoma (Cohort 2A), NSCLC (Cohort 2B), or colorectal adenocarcinoma (Cohort 2C), with unresectable locally advanced or metastatic disease, if 1) disease has progressed despite standard therapy, and no further standard therapy exists; or 2) standard therapy has proven to be ineffective, intolerable, or is considered inappropriate.
• Provide tumor tissue samples obtained from the initial diagnosis to study entry.
• At least one measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
• Life expectancy of at least 12 weeks.
• Adequate hematologic, hepatic and renal functions
• Male and female subjects of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception

You may not qualify if:

• Any prior therapy targeting CD39, CD73, or adenosine A2A receptor.
• Receipt of any investigational agents or devices within 4 weeks prior to the first dose of study drug.
• Prior treatment with the following therapies:
• Anticancer therapy within 30 days or 5 half-lives of the drug prior to the first dose of study drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered. Exception: hormonal and/or hormonal replacement therapy.
• A wash out of at least 2 weeks before the start of study drug for radiation to the extremities and 4 weeks for radiation to the chest, brain, or visceral organs is required.
• Prior allogeneic or autologous bone marrow transplantation or solid organ transplantation.
• Toxicity from previous anticancer treatment
• Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug.
• Subjects who received transfusion of blood products (including platelets or red blood cells), G-CSF, GM-CSF, recombinant erythropoietin, or recombinant thrombopoietin within 14 days prior to the first dose of study treatment.
• Major surgery within 4 weeks prior to the first dose of study treatment.
• Live vaccine therapies within 4 weeks prior to the first dose of study treatment.
• Recent history of allergen desensitization therapy within 4 weeks prior to the first dose of study treatment.
• Allergy or sensitivity to ES002023 or known allergies to CHO-produced antibodies
• Invasive malignancy or history of invasive malignancy other than disease under study within the last two years
• CNS metastases

Sponsors & Collaborators

• Elpiscience Biopharma, Ltd.: lead

Study Sites (7)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Fayetteville Oncology

Fayetteville, Arkansas, 72703, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Sarah Cannon Research Institute

Orlando, Florida, 32827, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

NEXT Austin

Austin, Texas, 78758, United States

Location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location

Study Officials

• Clinical Development

  Elpiscience Biopharma, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 13, 2021
• Study Start: December 23, 2021
• Primary Completion: October 13, 2022
• Study Completion: October 13, 2022
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)