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A 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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| DRUG: ES009
|
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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