Evaluating ES009 for advanced solid tumors

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

This study is testing a new treatment called ES009 to see if it can help people with advanced solid tumors by improving their immune response against cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Elpiscience Biopharma, Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 4 sites (Frankston and 3 other locations)
• Trial ID: NCT06007482 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ES009, a monoclonal antibody targeting LILRB2, in patients with locally advanced or metastatic solid tumors. The study is a first-in-human, open-label, multicenter, non-randomized trial designed to determine the maximum tolerated dose and optimal biological dose of ES009. By reprogramming suppressive myeloid cells, ES009 seeks to create a more favorable immune environment to combat cancer progression.

Who should consider this trial

Good fit: Ideal candidates include individuals with unresectable locally advanced or metastatic solid tumors that have progressed despite standard therapies.

Not a fit: Patients who have previously received therapies targeting LILRB2 or those with rapidly progressing disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While this approach is novel in targeting LILRB2, similar immunotherapy strategies have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Frankston and 3 other locations

• Peninsula and South Eastern Oncology and Haematology Group — Frankston, Australia (Recruiting)
• St George Private Hospital — Kogarah, Australia (Not_yet_recruiting)
• Scientia Clinical Research — Randwick, Australia (Recruiting)
• Sunshine Coast University Private Hospital — Sunshine Coast, Australia (Not_yet_recruiting)

Study contacts

• Study coordinator: Sydney Gong, PM

Conditions Advanced Solid Tumor; Leukocyte immunoglobulin-like receptor B2