Status:
COMPLETED
A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Elpiscience Biopharma Australia Pty. Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 adva...
Detailed 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 im...
Eligibility Criteria
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.
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06007482
Start Date
September 26 2023
End Date
February 18 2025
Last Update
June 23 2025
Active Locations (4)
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1
Peninsula and South Eastern Oncology and Haematology Group
Frankston, Australia
2
St George Private Hospital
Kogarah, Australia
3
Scientia Clinical Research
Randwick, Australia
4
Sunshine Coast University Private Hospital
Sunshine Coast, Australia