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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06007482




Registration number
NCT06007482
Ethics application status
Date submitted
10/08/2023
Date registered
23/08/2023
Date last updated
15/11/2023

Titles & IDs
Public title
A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors
Scientific title
An Open-Label, Multicenter, First-in-Human, Phase 1 Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
ES009-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ES009

Experimental: Dose Escalation Cohort - ES009 monotherapy dose level will be escalated in participants with advanced solid tumors.


Treatment: Drugs: ES009
ES009 is administered via intravenous infusion, once every 21 days.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The frequency and severity of adverse events of ES009
Timepoint [1] 0 0
1-3 years
Primary outcome [2] 0 0
Maximum tolerated dose (MTD) of ES009
Timepoint [2] 0 0
1-3 years
Primary outcome [3] 0 0
Optimal biological dose (OBD) of ES009
Timepoint [3] 0 0
1-3 years
Primary outcome [4] 0 0
Recommended phase 2 dose (RP2D) of ES009
Timepoint [4] 0 0
1-3 years
Primary outcome [5] 0 0
Maximum administered dose (MAD) of ES009
Timepoint [5] 0 0
1-3 years
Secondary outcome [1] 0 0
Maximum observed serum concentration (Cmax) of ES009
Timepoint [1] 0 0
1-3 years
Secondary outcome [2] 0 0
Trough observed serum concentration (Ctrough) of ES009
Timepoint [2] 0 0
1-3 years
Secondary outcome [3] 0 0
Area under the serum concentration time curve (AUC) of ES009
Timepoint [3] 0 0
1-3 years
Secondary outcome [4] 0 0
Time to Cmax (Tmax) of ES009
Timepoint [4] 0 0
1-3 years
Secondary outcome [5] 0 0
The terminal elimination half life of ES009
Timepoint [5] 0 0
1-3 years
Secondary outcome [6] 0 0
Immunogenicity of ES009
Timepoint [6] 0 0
1-3 years
Secondary outcome [7] 0 0
Preliminary antitumor activity of ES009
Timepoint [7] 0 0
1-3 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/08/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peninsula and South Eastern Oncology and Haematology Group - Frankston
Recruitment hospital [2] 0 0
St George Private Hospital - Kogarah
Recruitment hospital [3] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [4] 0 0
Sunshine Coast University Private Hospital - Sunshine Coast
Recruitment postcode(s) [1] 0 0
- Frankston
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment postcode(s) [4] 0 0
- Sunshine Coast

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Elpiscience Biopharma Australia Pty. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06007482
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sydney Gong, PM
Address 0 0
Country 0 0
Phone 0 0
86-021-50651310
Fax 0 0
Email 0 0
clinical-operation@elpiscience.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06007482