A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors

Last updated: June 20, 2025
Sponsor: Elpiscience Biopharma Australia Pty. Ltd.
Overall Status: Completed

Phase

1

Condition

Neoplasms

Treatment

ES009

Clinical Study ID

NCT06007482
ES009-1001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Capable of giving signed informed consent.

  • Histological or cytological documentation of unresectable locally advanced ormetastatic solid tumors, if 1) disease has progressed despite standard therapy, andno further standard therapy exists; or 2) standard therapy has proven to beineffective or intolerable or is considered inappropriate.

  • At least one measurable lesion per RECIST v1.1.

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.

  • Life expectancy of at least 12 weeks.

  • Adequate hematologic, hepatic, renal and coagulation function per protocol.

  • Male and female subjects of childbearing potential must be willing to completelyabstain or agree to use a highly effective method of contraception per protocol.

Exclusion

Exclusion Criteria:

  • Any prior therapy targeting LILRB2.

  • Receipt of any investigational therapies within 28 days or 5 half-lives prior to thefirst dose of study drug.

  • Prior treatment with the following therapies:• Anticancer therapy within 28 days or 5 half-lives of the drug prior to the first dose of study drug, whichever isshorter. Exception: hormonal replacement therapy.• A wash out of at least 2 weeksbefore the start of study drug for radiation to the extremities and 4 weeks forradiation to the chest, brain, or visceral organs is required.

  • Prior allogeneic or autologous bone marrow transplantation or solid organtransplantation.

  • Toxicity from previous anticancer treatment per protocol.

  • Treatment with systemic immunosuppressive medications within 4 weeks prior to thefirst dose of study drug with certain exceptions.

  • Subjects who received transfusion of blood products (including platelets or redblood cells), G-CSF, GM-CSF, recombinant erythropoietin, or recombinantthrombopoietin 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 firstdose of study treatment.

  • Known allergies to CHO-produced antibodies.

  • Invasive malignancy or history of invasive malignancy other than disease under studywithin the last two years with certain exceptions.

  • CNS metastases with certain exceptions.

  • Active autoimmune disease or documented history of autoimmune disease that requiredsystemic steroids or other immunosuppressive medications.

  • Active interstitial lung disease (ILD) or pneumonitis requiring treatment withsteroids or other immunosuppressive medications.

  • Active infection requiring systemic therapy, known human immunodeficiency virus (HIV) infection, or positive test for hepatitis B active infection (HBsAg) orhepatitis C active infection (hepatitis C antibody).

  • Current active liver or biliary disease (with the exception of Gilbert's syndrome orasymptomatic gallstones, liver metastases, or otherwise stable chronic liver diseaseper investigator assessment).

  • History or evidence of cardiac abnormalities.

  • Pregnant or nursing females.

  • Any known, documented, or suspected history of illicit substance abuse that wouldpreclude subject from participation, unless clinically justified.

  • Any other disease or clinically significant abnormality in laboratory parameters,including serious medical or psychiatric illness/condition, which in the judgment ofthe Investigator might compromise the safety of the subject or integrity of thestudy, interfere with the subject participation in the trial or compromise the trialobjectives.

  • Involvement in the planning and/or conduct of the study (applies to both Sponsor/CROstaff and staff at the study site)

  • Judgment by the Investigator that the subject is unlikely to comply with studyprocedures, restrictions and requirements.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: ES009
Phase: 1
Study Start date:
September 26, 2023
Estimated Completion Date:
February 18, 2025

Study Description

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.

Connect with a study center

  • Peninsula and South Eastern Oncology and Haematology Group

    Frankston,
    Australia

    Site Not Available

  • St George Private Hospital

    Kogarah,
    Australia

    Site Not Available

  • Scientia Clinical Research

    Randwick,
    Australia

    Site Not Available

  • Sunshine Coast University Private Hospital

    Sunshine Coast,
    Australia

    Site Not Available

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