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

NCT06007482 | Completed Phase 1

• 1 other identifier: ES009-1001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

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 advanced solid tumors.

Conditions

Advanced Solid Tumor

Keywords

Leukocyte immunoglobulin-like receptor B2 (LILRB2)

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Maximum observed serum concentration (Cmax) of ES009

  1-3 years

• Trough observed serum concentration (Ctrough) of ES009

  1-3 years

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

  1-3 years

• Time to Cmax (Tmax) of ES009

  1-3 years

• The terminal elimination half life of ES009

  1-3 years

Study Arms (1)

Dose Escalation Cohort

EXPERIMENTAL

ES009 monotherapy dose level will be escalated in participants with advanced solid tumors.

Drug: ES009

Interventions

ES009 DRUG

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

Dose Escalation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elpiscience Biopharma Australia Pty. Ltd.: lead

Study Sites (4)

Peninsula and South Eastern Oncology and Haematology Group

Frankston, Australia

Location

St George Private Hospital

Kogarah, Australia

Location

Scientia Clinical Research

Randwick, Australia

Location

Sunshine Coast University Private Hospital

Sunshine Coast, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 23, 2023
• Study Start: September 26, 2023
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: June 23, 2025

Record last verified: 2025-06

Locations

AU (4)