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Trial registered on ANZCTR


Registration number
ACTRN12620001178932
Ethics application status
Approved
Date submitted
8/10/2020
Date registered
9/11/2020
Date last updated
17/09/2023
Date data sharing statement initially provided
9/11/2020
Date results information initially provided
17/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of EARLI-001 in subjects with lung cancer
Scientific title
A Phase 1, open label, single dose, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of EARLI-001 in subjects with locally advanced or metastatic lung cancer or subjects with metastases in the lung or liver of a primary cancer origin other than lung cancer
Secondary ID [1] 301970 0
Protocol EARLI-001-CT01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 318531 0
Condition category
Condition code
Cancer 316536 316536 0 0
Lung - Non small cell
Cancer 316537 316537 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Up to 30 subjects with locally advanced or metastatic lung cancer will be enrolled in this study in up to 4 cohorts. Subjects within each cohort will receive a single dose of EARLI-001 given by intravenous administration. The doses will be administered in the clinic to ensure adherence.
The doses to be administered are noted below:
Cohort 1 - 0.003 mg/kg
Cohort 2 - 0.013 mg/kg
Cohort 3 - 0.054 mg/kg
Cohort 4 (Expansion Cohort) - The cohort 4 dose is to be determined and will be the highest tolerable dose or a lower alternate dose as selected by the Principal Investigators and Sponsor
Intervention code [1] 318258 0
Early detection / Screening
Intervention code [2] 318259 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324664 0
To evaluate the safety of EARLI-001 in subjects with lung cancer through the assessment of treatment-emergent adverse events assessed through regular solicitation of subjects and review of physical examination data, vital sign data (including temperature taken orally, blood pressure determined using a digital blood pressure monitor, pulse rate and respiration rate), ECG data and clinical laboratory assessments of blood and urine: hematology (standard panel), chemistry (standard panel). Example of adverse events that might occur include transient increases in liver function tests, and transient decreases in white blood cells, granulocytes and red blood cells.
Timepoint [1] 324664 0
- Treatment-emergent adverse events will be collected from the time of dosing on Day 1 through the Day 60 final follow-up visit - Physical examinations will be conducted at screening, on Day 1, Day 3, Day 5, Day 8, Day 15, Day 30 and Day 60 - Clinical laboratory assessments of blood and urine will be collected at screening, pre-dose on Day 1, Day 3, Day 5, Day 8, Day 15, Day 30 and Day 60 - ECGs will be collected at screening, pre-dose on Day 1, 15, 30, 45 and 60 minutes and 2, and 4 hours after the start of dosing on Day 1, Day 3, Day 5, and Day 15 - Vital signs will be collected at screening, pre-dose on Day 1, 15, 30, 45 and 60 minutes and 2, and 4 hours after the start of dosing on Day 1, Day 3, Day 5, Day 8, Day 15, Day 30 and Day 60
Secondary outcome [1] 385360 0
To characterise the pharmacokinetic profile of EARLI-001 in subjects with lung cancer. Pharmacokinetic parameters include maximal concentration (Cmax), time for maximal concentration (Tmax), area under the concentration–time curve (AUC, 0–10 h), half-life (t1/2), elimination rate constant (Ke), and total body clearance (CL).
Timepoint [1] 385360 0
Blood samples for PK assessments will be taken at the following times: screening, pre-dose, and 4 hours after dosing on Day 1, and on Day 3, Day 5, Day 8, Day 30 and Day 60 (9 blood draws)
Secondary outcome [2] 385361 0
To assess the pharmacodynamic effect of EARLI-001 in subjects with lung cancer through measurement of the levels of the biomarker secreted embryonic alkaline phosphatase (SEAP) and comparison to baseline levels
Timepoint [2] 385361 0
Blood samples for PD assessments will be taken at the following times: screening, pre-dose, and 4 hours after dosing on Day 1, and on Day 3, Day 5, Day 8, Day 30 and Day 60 (9 blood draws)

Eligibility
Key inclusion criteria
1. Signed written informed consent prior to the initiation of any study-specific procedures.
2. Males and females aged 18 years or older at time of consent
3. Histologically or cytologically confirmed locally advanced or metastatic lung cancer. Subjects with metastases in the lung or liver of a primary cancer origin other than lung cancer may also be considered for inclusion
4. Expected survival greater than 3 months
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Body mass index (BMI) less than or equal to 32.0 kg/m2
7. Adequate organ and marrow function based on clinical laboratory assessments
8. Female subjects must be of non-childbearing potential
9. Male patients must use highly effective contraception methods consisting of 2 forms of birth control starting at screening and continuing throughout the study period and for 3 months after the last study treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Females of child-bearing potential or who are breastfeeding or who have a positive pregnancy test
2. Has a known severe hypersensitivity to any of the excipients in the formulation of EARLI-001.
3. Has a clinically significant history or presence of ECG findings as judged by the PI or designee at screening
4. Has received treatment within 30 days or 5 half-lives (whichever is greater) before dosing for their current diagnosis of histologically or cytologically confirmed locally advanced or metastatic lung cancer or their current diagnosis with metastases in the lung or liver of a primary cancer origin other than lung cancer. Subjects will be permitted to start on an approved treatment after the Day 8 assessments have been completed.
5. Has received treatment with another investigational drug, or investigational device, within 30 days or 5 half-lives (whichever is longer) before dosing.
6. Is currently taking heparin, or a heparin analog.
7. Has signs or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocol.
8. Is unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements
9. Other unspecified reasons that, in the opinion of the PI or Sponsor, make the patient unsuitable for enrollment.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
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
Single group
Other design features
Dose escalation
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
This is an early development study, and therefore no statistical considerations were involved in the sample size determination. The sample size was chosen based on clinical experience. It is expected that the sample size of 9 to 30 subjects in up to 4 cohorts should be adequate for evaluation of safety, tolerability, pharmacokinetics and pharmacodynamics in this single ascending dose study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/12/2020
Actual
28/06/2021
Date of last participant enrolment
Anticipated
1/03/2023
Actual
29/11/2022
Date of last data collection
Anticipated
1/05/2023
Actual
27/01/2023
Sample size
Target
30
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 17204 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 17205 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [3] 22060 0
Icon Cancer Care Adelaide - Kurralta Park
Recruitment hospital [4] 23053 0
Peninsula Oncology Centre - Frankston
Recruitment postcode(s) [1] 30912 0
3084 - Heidelberg
Recruitment postcode(s) [2] 30913 0
2050 - Camperdown
Recruitment postcode(s) [3] 37184 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 38383 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 306393 0
Commercial sector/Industry
Name [1] 306393 0
Earli, Pty Ltd
Country [1] 306393 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Earli, Pty Ltd
Address
c/o William Buck
Level 20
181 William Street
Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 306897 0
None
Name [1] 306897 0
Address [1] 306897 0
Country [1] 306897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306592 0
Austin Health
Ethics committee address [1] 306592 0
145 Studley Road
PO Box 5555
Heidelberg Victoria 3084
Ethics committee country [1] 306592 0
Australia
Date submitted for ethics approval [1] 306592 0
27/10/2020
Approval date [1] 306592 0
28/04/2021
Ethics approval number [1] 306592 0
Ethics committee name [2] 306594 0
Bellberry Limited Human Research Ethics Committee
Ethics committee address [2] 306594 0
29 Glen Osmond Road
EASTWOOD SOUTH AUSTRALIA 5063
Ethics committee country [2] 306594 0
Australia
Date submitted for ethics approval [2] 306594 0
22/10/2020
Approval date [2] 306594 0
11/01/2021
Ethics approval number [2] 306594 0

Summary
Brief summary
This project is testing the safety, pharmacokinetics (PK, the amount of study drug in your blood), and pharmacodynamics of single intravenous doses of a new drug called EARLI-001. EARLI-001 is a method for the detection of cancers.

Who is it for?
You may be eligible for this study if you are an adult man or woman over the age of 18 who has been newly diagnosed with locally advanced or metastatic lung cancer.

Study details
Participants will receive a single dose of EARLI-001 at one of 4 different dose levels. EARLI-001 will be given to you intravenously.

Total participation will last up to 60 days which includes 8 visits to the clinic for assessments and to collect blood and urine samples.

It is hoped that this research will help determine the safety of EARLI-001 when given to patients with lung cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104398 0
Prof Andrew Scott
Address 104398 0
Olivia Newton-John Cancer Research Institute
145 Studley Road
Heidelberg
VIC 3084
Country 104398 0
Australia
Phone 104398 0
+61 394963335
Fax 104398 0
Email 104398 0
[email protected]
Contact person for public queries
Name 104399 0
Dr David Suhy
Address 104399 0
Earli Pty Ltd
c/o William Buck
Level 20, 181 William Street
Melbourne, VIC 3000
Country 104399 0
Australia
Phone 104399 0
+1 925 8589299
Fax 104399 0
Email 104399 0
[email protected]
Contact person for scientific queries
Name 104400 0
Dr David Suhy
Address 104400 0
Earli Pty Ltd
c/o William Buck
Level 20, 181 William Street
Melbourne, VIC 3000
Country 104400 0
Australia
Phone 104400 0
+1 925 858 9299
Fax 104400 0
Email 104400 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be made available for this study. All subject data obtained will be de-identified and captured in a final study report that will not identify individual participants


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.