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

PHASE1RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-09-07

Primary completion: 2024-08-15

Study completion finish: 2025-08-15

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06007482

Intervention or treatment

DRUG: ES009

Conditions

• Advanced Solid Tumor

Condition: Advanced Solid Tumor
DRUG: ES009
Frankston, Not Specified, Australia and more
Sponsor: Elpiscience Biopharma Australia Pty. Ltd.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Peninsula and South Eastern Oncology and Haematology Group

Research sites nearby

Select from list below to view details:

Peninsula and South Eastern Oncology and Haematology Group
Frankston, Not Specified, Australia
St George Private Hospital
Kogarah, Not Specified, Australia
Scientia Clinical Research
Randwick, Not Specified, Australia
Sunshine Coast University Private Hospital
Sunshine Coast, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dose Escalation Cohort ES009 monotherapy dose level will be escalated in participants with advanced solid tumors.	DRUG: ES009 ES009 is administered via intravenous infusion, once every 21 days.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
The frequency and severity of adverse events of ES009	Adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.	1-3 years
Maximum tolerated dose (MTD) of ES009	The MTD of ES009 will be determined.	1-3 years
Optimal biological dose (OBD) of ES009	The OBD of ES009 will be determined.	1-3 years
Recommended phase 2 dose (RP2D) of ES009	The RP2D of ES009 will be determined.	1-3 years
Maximum administered dose (MAD) of ES009	The MAD of ES009 will be determined.	1-3 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Maximum observed serum concentration (Cmax) of ES009	Maximum observed serum concentration (Cmax) of ES009 will be measured.	1-3 years
Trough observed serum concentration (Ctrough) of ES009	Trough observed serum concentration (Ctrough)of ES009 will be measured.	1-3 years
Area under the serum concentration time curve (AUC) of ES009	Area under the serum concentration time curve (AUC) of ES009 will be measured.	1-3 years
Time to Cmax (Tmax) of ES009	Time to Cmax (Tmax) of ES009 will be measured.	1-3 years
The terminal elimination half life of ES009	The terminal elimination half-life (t 1/2) of ES009 will be measured.	1-3 years
Immunogenicity of ES009	Frequency of anti-drug antibodies (ADA) against ES009 will be determined.	1-3 years
Preliminary antitumor activity of ES009	Tumor response will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.	1-3 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors