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Trial registered on ANZCTR


Registration number
ACTRN12624000085572
Ethics application status
Approved
Date submitted
30/11/2023
Date registered
31/01/2024
Date last updated
17/07/2024
Date data sharing statement initially provided
31/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Gallium Imaging Pilot Study in Metastatic Melanoma
Scientific title
A Multicentre, Phase 1 Study Investigating the Safety, Tumor Uptake, Biodistribution, and Dosimetry of 68Ga-A9T-3202 in Participants with Locally Advanced or Metastatic Melanoma
Secondary ID [1] 310850 0
A9T-3202-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Melanoma 332204 0
Locally Advanced Melanoma 334433 0
Condition category
Condition code
Cancer 328917 328917 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves the use of an investigational imaging product, 68Ga-A9T-3202.

68Ga-A9T-3202 is an investigational imaging agent being developed for patients with MC1R positive metastatic melanoma. A single dose of 68Ga-A9T-3202 will be administered via intravenous injection by a Nuclear Medicine Physician prior to whole body PET-CT scans being performed at 4 timepoints post dose (15mins, 30mins, 60mins and 150mins post dose for conventional scanners; dynamic scan at 0-30mins post dose, static scans at 60mins, and 120min with an optional scan at 240mins post dose for Long Axial Field-of-View scanners). The radioactivity of the injected dose will be determined according to body weight, with a target administration activity of 2MBq/kg ±10%. The maximum administered activity will not exceed 300MBq.
Intervention code [1] 327516 0
Diagnosis / Prognosis
Comparator / control treatment
Active Comparator: 18FDG-PET & CT Scans, current first line scan for diagnosis.
18FDG-PET & CT Scans will be collected during the screening period, within 28 days of Day 1.
Control group
Active

Outcomes
Primary outcome [1] 336726 0
Safety and tolerability of a single intravenous dose of 68Ga-A9T-3202
Timepoint [1] 336726 0
SAEs will be assessed continuously from the time of consent until the completion of the End of Observation Visit (1 day post IP administration +1 day). AEs will be assessed continuously from the time of IP administration (Day 1) until the completion of the End of Observation Visit (1 day post IP administration +1 day).

Clinical safety blood tests and vital signs will be assessed at every study visit (screening visit, Day 1 and End of Observation Visit at Day 2) from the screening visit until the End of Observation Visit (Day 2 +1 day), and at other times if deemed necessary by the Investigator.
Secondary outcome [1] 429482 0
Normal tissue biodistribution and tumour update and dosimetry (all components will be assessed as a composite secondary outcome)
Timepoint [1] 429482 0
Day 1 - Conventional Scanners: 15mins, 30mins, 60mins, and 150mins post dose
Day 1 - Long Axial Field-of-View (LAFOV) Scanners: Dynamic scan at 0-30mins post dose, static scans at 60mins, 120mins and 240mins post dose.
Secondary outcome [2] 429483 0
Level of correlation between 68Ga-A9T-3202 and 18FDG-PET and CT Scans
Timepoint [2] 429483 0
• Screening 18F-FDG-PET and CT Scans
• Day 1 68GA-A9T-3202 whole body PET-CT scans

Eligibility
Key inclusion criteria
1. Has histologically or cytologically confirmed locally advanced or metastatic melanoma.
2. 18F-FDG-PET proven disease in the recent 3 months. 18F-FDG-PET scans performed prior to date of consent, as part of a participant’s routine clinical assessments, but within the 28 day screening window can be used to assess eligibility and are not required to be repeated unless specified by the Study Investigator.
3. Age greater than or equal to 18 years old.
4. Mentally competent and able to understand and sign the Informed Consent Form.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
6. Expected life expectancy of >12 weeks per the Investigator.
7. Participants must have at least one lesion with the following characteristics (measured by diagnostic CT imaging). CT scans performed prior to date of consent, as part of a participant’s routine clinical assessments, but within the 28 day screening window can be used to assess eligibility and are not required to be repeated unless specified by the Study Investigator.:
• visceral organ metastases greater than 1 cm
• nodal metastases greater than 1 cm short axis diameter
• bone lesions with a soft-tissue component of at least 1 cm in short axis
8. Participants with brain metastases are eligible provided they meet the following criteria:
a. Radiotherapy or surgery for brain metastases was completed at least 4 weeks prior to
the first administration of investigational product.
b. Symptoms are stable and steroid/antiepileptic doses remain unchanged for a
minimum of 4 weeks.
9. At least 4 weeks from prior major surgery.
10. Willing to use contraceptive measures: women of childbearing potential and men must agree to use effective methods of contraception (hormonal or barrier methods or abstinence) before study entry, during study participation, and for 1 month following exposure to the investigational product.
11. Laboratory values at screening must be as follows:
a. Hematology:
i. Absolute neutrophil count greater than or equal to 1,500 cells/mm3.
ii. Platelet count greater than or equal to 100,000 cells/mm3.
iii. Hemoglobin greater than or equal to 10 g/dL (transfusion is acceptable to meet this
criterion but must be longer than 14 days before administration).
b. Renal:
i. Serum creatinine < 1.5 × upper limit of normal (ULN) or creatinine clearance greater
than or equal to 60 mL/min based on the Cockcroft-Gault glomerular filtration rate
estimation.
c. Coagulation:
i. International normalized ratio must be < 1.5 × ULN.
ii. Prothrombin time or activated partial thromboplastin time greater than or equal to
1.5 × ULN unless undergoing anticoagulation therapy.
d. Cardiac QTc<0.44sec based on 12-lead electrocardiogram within 30 days of
enrolment.
e. Liver:
i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than or
equal to 2.5 × ULN or greater than or equal to 5 x ULN in the presence of liver
metastases .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have any medical condition that would, in the Investigator’s judgment, prevent the
participant’s full participation in the clinical study due to safety concerns or compliance
with clinical study procedures such as participants with severe claustrophobia who are
unresponsive to oral anxiolytics, participants with low back pain who cannot lie
comfortably on an imaging table, participants who are hyperactive or hyperkinetic such
that they cannot tolerate lying still for multiple time-point imaging procedures, etc.
2. Residual toxicity > Grade 1 from prior anticancer therapy (except alopecia and/or fatigue) 3. History of uncontrolled allergic reactions and/or known or expected hypersensitivity to
peptide therapeutics, 68Ga-A9T-3202.
4. Cardiovascular exclusions:
a. Has a medical condition that the Investigator assesses could interfere with the
administration of the diagnostic agent or assessment of toxicity or response to the
diagnostic agent.
b. Has clinically significant cardiac disease not controlled on medical therapy (e.g.,
congestive cardiac failure, arrhythmia, coronary heart disease).
c. Has a medical history of myocardial infarction or unstable angina within 6 months
before Day 1.
5. Other exclusions:
a. Was previously enrolled in this study.
b. Is actively enrolled in another clinical study unless it is an observational
(noninterventional) clinical study or the follow-up component of an interventional
study.
c. Use of another systemic anticancer therapy within 3 weeks prior to Day 1 or 5 half-lives,
whichever is shorter, unless agreed to following discussion with the Medical Monitor.
6. Prior External Beam Radiation Therapy (EBRT)
• Volume > 25% of the bone marrow.
• Within 4 weeks of 68Ga-A9T-3202 dosing. (Exceptions may be approved on a case-by-
case basis in discussion with study Sponsor.)
7. Recent medical concerns exclusions:
• Has evidence of active infection requiring IV antibiotics within 7 days prior to Day 1.
• Has active uncontrolled bleeding or a bleeding diathesis within 7 days prior to Day 1.
• Has serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture
within 7 days prior to Day 1.
• History of organ transplant.
8. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with study Sponsor.
9. Participants with a history of leptomeningeal disease may not participate even if clinically
stable.
10. Pregnant or lactating.

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
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/02/2024
Actual
24/04/2024
Date of last participant enrolment
Anticipated
22/09/2024
Actual
Date of last data collection
Anticipated
23/09/2024
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315100 0
Commercial sector/Industry
Name [1] 315100 0
Alpha-9 Theranostics Australia Pty Ltd
Country [1] 315100 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Alpha-9 Theranostics Australia Pty Ltd
Address
Level 40, 2 Park Street, Sydney, NSW 2000
Country
Australia
Secondary sponsor category [1] 317121 0
Commercial sector/Industry
Name [1] 317121 0
GenesisCare Clinical CRO Pty Ltd
Address [1] 317121 0
Building 7, Level 1, The Mill, 41-43 Bourke Road Alexandria NSW 2015
Country [1] 317121 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314041 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 314041 0
123 Glen Osmond Road Eastwood Adelaide South Australia 5063
Ethics committee country [1] 314041 0
Australia
Date submitted for ethics approval [1] 314041 0
18/10/2023
Approval date [1] 314041 0
11/01/2024
Ethics approval number [1] 314041 0

Summary
Brief summary
This study aims to assess the safety and tolerability of a new tumour imaging agent in patients with locally advanced or metastatic melanoma.

Who is it for?
You may be eligible for this study if you are an adult aged 18 years or older and have been diagnosed with locally advanced or metastatic melanoma. All potential participants will be reviewed by the study investigators to ensure that they meet additional health criteria before enrolment.

Study details
All participants who choose to consent in this study will undergo a screening visit to assess their eligibility. An 18F-FDG-PET and CT scans will be required for assessing participant eligibility, however if these scans were performed as part of standard of care prior to the date of consent but are within 28 days of the Day 1, they may not need to be repeated. Each participant's circumstances will be assessed by a study investigator and participants will be advised if scans need to be repeated. If eligible, participants will receive a single dose of 68Ga-A9T-3202 via intravenous injection, and then undergo 4 whole body PET-CT scans at set timepoints on the day of administration. Participants will then complete an End of Observation visit (one day post IP administration) to check participant safety and tolerability of 68Ga-A9T-3202.

It is hoped this research will demonstrate that 68Ga-A9T-3202 is safe and well tolerated by patients with metastatic melanoma, and provide more accurate staging and treatment response evaluation when compared to the current standard of care PET/CT imaging.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130218 0
Prof Rodney Hicks
Address 130218 0
Melbourne Theranostic Innovation Centre, Level 8/14-20 Blackwood St, North Melbourne VIC 3051
Country 130218 0
Australia
Phone 130218 0
+61 03 9454 5800
Fax 130218 0
Email 130218 0
[email protected]
Contact person for public queries
Name 130219 0
Sam Vohra
Address 130219 0
Melbourne Theranostic Innovation Centre, Level 8/14-20 Blackwood St, North Melbourne VIC 3051
Country 130219 0
Australia
Phone 130219 0
+61 03 8373 7666
Fax 130219 0
Email 130219 0
[email protected]
Contact person for scientific queries
Name 130220 0
Rodney Hicks
Address 130220 0
Melbourne Theranostic Innovation Centre, Level 8/14-20 Blackwood St, North Melbourne VIC 3051
Country 130220 0
Australia
Phone 130220 0
+61 03 9454 5800
Fax 130220 0
Email 130220 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
No individual participant data will be publicly available. Data will be anonymised and analysed as a cohort.


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.