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Advanced Solid TumorPhase 1NCT05075564

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

A Phase 1 study testing Part 1 ES002023 and Part 2 ES002023 in people with Advanced Solid Tumor, run by Elpiscience Biopharma, Ltd. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Part 1 ES002023 and Part 2 ES002023
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
7 sitesUnited States
Study dates
23 Dec 2021to 13 Oct 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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
  • Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications
  • Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
  • Active infection requiring systemic therapy, known human immunodeficiency virus (HIV) infection, or positive test for hepatitis B active infection (HBsAg) or hepatitis C active infection (hepatitis C antibody).
  • Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per investigator assessment).
  • History or evidence of cardiac abnormalities

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • NEXT Austin

    Austin, Texas, 78758

  • NEXT Virginia

    Fairfax, Virginia, 22031

  • Fayetteville Oncology

    Fayetteville, Arkansas, 72703

  • UCLA

    Los Angeles, California, 90095

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Sarah Cannon Research Institute

    Orlando, Florida, 32827

  • HonorHealth

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Part 1 ES002023, Part 2 ES002023

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Part 1 ES002023Drug

    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 ES002023Drug

    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.

Study groups in NCT05075564
Study groupRoleWhat they receive
Part 1 dose escalationExperimentalES002023 doses will be escalated in patients with advanced solid tumors with approximately 30 subjects.
Receives: Drug: Part 1 ES002023
Part 2 dose expansionExperimentalPart 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.
Receives: Drug: Part 2 ES002023

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1-3 years

  2. 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

    Measured: 1-3 years

Secondary outcomes (9)

  1. Maximum observed serum concentration (Cmax) of ES002023

    Maximum observed serum concentration (Cmax) of ES002023 will be measured.

    Measured: 1-3 years

  2. Trough observed serum concentration (Ctrough) of ES002023

    Trough observed serum concentration (Ctrough)of ES002023 will be measured.

    Measured: 1-3 years

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

    Area under the serum concentration time curve (AUC) of ES002023 will be measured.

    Measured: 1-3 years

  4. Time to Cmax (Tmax) of ES002023

    Time to Cmax (Tmax) of ES002023 will be measured.

    Measured: 1-3 years

  5. The terminal elimination half life of ES002023

    The terminal elimination half-life (t 1/2) of ES002023 will be measured.

    Measured: 1-3 years

  6. The clearance of ES002023

    A pharmacokinetic measurement of the volume of plasma from which ES002023 is completely removed per unit time.

    Measured: 1-3 years

  7. The volume of distribution of ES002023

    The amount of of ES002023 in the body divided by the plasma concentration will be measured.

    Measured: 1-3 years

  8. The immunogenicity of ES002023

    The presence and the frequency of anti-drug antibodies (ADA) against ES002023 will be measured.

    Measured: 1-3 years

  9. 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.

    Measured: 1-3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2021
  2. Study start23 Dec 2021
  3. Primary completion13 Oct 2022
  4. Study completion13 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05075564
Sponsor's protocol ID
ES002023-1001
Status last verified
May 2025
First submitted
21 Sep 2021
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Part 1 ES002023 and Part 2 ES002023 in people with Advanced Solid Tumor, run by Elpiscience Biopharma, Ltd. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The frequency and severity of adverse events of ES002023 (time frame: 1-3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05075564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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