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Advanced Solid TumorPhase 1NCT06007482

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

A Phase 1 study testing ES009 in people with Advanced Solid Tumor, run by Elpiscience Biopharma Australia Pty. Ltd. at 4 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
ES009
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
4 sitesAustralia
Study dates
26 Sep 2023to 18 Feb 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Peninsula and South Eastern Oncology and Haematology Group

    Frankston

  • St George Private Hospital

    Kogarah

  • Scientia Clinical Research

    Randwick

  • Sunshine Coast University Private Hospital

    Sunshine Coast

Other trials in Australia

About this study

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

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.

Read the 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 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.

Being tested
ES009
Keywords
Leukocyte immunoglobulin-like receptor B2 (LILRB2)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ES009Drug

    ES009 is administered via intravenous infusion, once every 21 days.

Study groups in NCT06007482
Study groupRoleWhat they receive
Dose Escalation CohortExperimentalES009 monotherapy dose level will be escalated in participants with advanced solid tumors.
Receives: Drug: ES009

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1-3 years

  2. Maximum tolerated dose (MTD) of ES009

    The MTD of ES009 will be determined.

    Measured: 1-3 years

  3. Optimal biological dose (OBD) of ES009

    The OBD of ES009 will be determined.

    Measured: 1-3 years

  4. Recommended phase 2 dose (RP2D) of ES009

    The RP2D of ES009 will be determined.

    Measured: 1-3 years

  5. Maximum administered dose (MAD) of ES009

    The MAD of ES009 will be determined.

    Measured: 1-3 years

Secondary outcomes (7)

  1. Maximum observed serum concentration (Cmax) of ES009

    Maximum observed serum concentration (Cmax) of ES009 will be measured.

    Measured: 1-3 years

  2. Trough observed serum concentration (Ctrough) of ES009

    Trough observed serum concentration (Ctrough)of ES009 will be measured.

    Measured: 1-3 years

  3. Area under the serum concentration time curve (AUC) of ES009

    Area under the serum concentration time curve (AUC) of ES009 will be measured.

    Measured: 1-3 years

  4. Time to Cmax (Tmax) of ES009

    Time to Cmax (Tmax) of ES009 will be measured.

    Measured: 1-3 years

  5. The terminal elimination half life of ES009

    The terminal elimination half-life (t 1/2) of ES009 will be measured.

    Measured: 1-3 years

  6. Immunogenicity of ES009

    Frequency of anti-drug antibodies (ADA) against ES009 will be determined.

    Measured: 1-3 years

  7. 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.

    Measured: 1-3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start26 Sep 2023
  3. Primary completion18 Feb 2025
  4. Study completion18 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06007482
Sponsor's protocol ID
ES009-1001
Status last verified
Jun 2025
First submitted
10 Aug 2023
Last updated
23 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ES009 in people with Advanced Solid Tumor, run by Elpiscience Biopharma Australia Pty. Ltd. at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The frequency and severity of adverse events of ES009 (time frame: 1-3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06007482.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2025.

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