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RecruitingLast updated: 3 April 2024

This study is evaluating how safe, tolerable and effective a new targeted therapy (called ES009) is in people with advanced solid cancersAn Open-Label, Multicenter, First-in-Human, Phase 1 Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors

Clinical summary

Summary

Eligible participants will be assigned to receive the study drug (ES009) as monotherapy in escalating doses, with the aim of determining the maximum tolerated dose (MTD), maximum administered dose (MAD), optimal biological dose (OBD), and recommended phase 2 dose (RP2D). ES009 will be administered via intravenous infusion once every 21 days.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Elpiscience Biopharma Australia Pty. Ltd

Scientific Title

An Open-Label, Multicenter, First-in-Human, Phase 1 Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors

Eligibility

Inclusion

  • Capable of giving signed informed consent.
  • 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 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 completely abstain or agree to use a highly effective method of contraception per protocol.

Exclusion

  • Any prior therapy targeting LILRB2.
  • Receipt of any investigational therapies within 28 days or 5 half-lives prior to the first 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 is shorter. Exception: 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 per protocol.
  • Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug with certain exceptions.
  • 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.
  • Known allergies to CHO-produced antibodies.
  • Invasive malignancy or history of invasive malignancy other than disease under study within the last two years with certain exceptions.
  • CNS metastases with certain exceptions.
  • Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications.
  • Active interstitial lung disease (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.
  • Pregnant or nursing females.
  • Any known, documented, or suspected history of illicit substance abuse that would preclude 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 of the Investigator might compromise the safety of the subject or integrity of the study, interfere with the subject participation in the trial or compromise the trial objectives.
  • Involvement in the planning and/or conduct of the study (applies to both Sponsor/CRO staff and staff at the study site)
  • Judgment by the Investigator that the subject is unlikely to comply with study procedures, restrictions and requirements.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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