A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors
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ClinicalTrials.gov Identifier: NCT06007482 |
Recruitment Status :
Recruiting
First Posted : August 23, 2023
Last Update Posted : November 15, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | August 10, 2023 | ||||
First Posted Date ICMJE | August 23, 2023 | ||||
Last Update Posted Date | November 15, 2023 | ||||
Actual Study Start Date ICMJE | September 7, 2023 | ||||
Estimated Primary Completion Date | August 15, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors | ||||
Official Title ICMJE | An Open-Label, Multicenter, First-in-Human, Phase 1 Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors | ||||
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. | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Solid Tumor | ||||
Intervention ICMJE | Drug: ES009
ES009 is administered via intravenous infusion, once every 21 days.
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Study Arms ICMJE | Experimental: Dose Escalation Cohort
ES009 monotherapy dose level will be escalated in participants with advanced solid tumors.
Intervention: Drug: ES009
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 15, 2025 | ||||
Estimated Primary Completion Date | August 15, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Australia | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT06007482 | ||||
Other Study ID Numbers ICMJE | ES009-1001 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Elpiscience Biopharma, Ltd. ( Elpiscience Biopharma Australia Pty. Ltd. ) | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Elpiscience Biopharma Australia Pty. Ltd. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Elpiscience Biopharma, Ltd. | ||||
Verification Date | September 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |