Phase
Condition
Neoplasms
Treatment
ES009
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Peninsula and South Eastern Oncology and Haematology Group
Frankston,
AustraliaSite Not Available
St George Private Hospital
Kogarah,
AustraliaSite Not Available
Scientia Clinical Research
Randwick,
AustraliaSite Not Available
Sunshine Coast University Private Hospital
Sunshine Coast,
AustraliaSite Not Available

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