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Trial registered on ANZCTR


Registration number
ACTRN12624001377527
Ethics application status
Approved
Date submitted
26/09/2024
Date registered
20/11/2024
Date last updated
20/11/2024
Date data sharing statement initially provided
20/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A study determining the safety of a new PET scan tracer ([68Ga]Ga-A9-5209) in people with advanced cancer.
Scientific title
A Phase 1 Study Investigating the Safety, Tumor Uptake, Biodistribution, and Dosimetry of PET tracer [68Ga]Ga-A9-5209 in Participants with Select Advanced or Metastatic Solid Tumors.
Secondary ID [1] 312977 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metastatic breast cancer 335158 0
metastatic prostate cancer 335357 0
metastatic non small cell lung cancer 335358 0
metastatic small cell lung cancer 335359 0
metastatic mesothelioma 335360 0
Condition category
Condition code
Cancer 331651 331651 0 0
Breast
Cancer 331652 331652 0 0
Prostate
Cancer 331653 331653 0 0
Lung - Non small cell
Cancer 331655 331655 0 0
Lung - Small cell
Cancer 331656 331656 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
[18F]FDG-PET and/or [68Ga]Ga PSMA 11-PET and/or [18F]DCFPyL-PET scans may be performed during screening for disease confirmation.
Following an ultra-low dose CT scan for attenuation correction, [68Ga]Ga A9 5209 will be administered to all participants as a slow intravenous push using an intravenous catheter, followed by a flush of 10 to 20 mL of normal saline for the Whole Body PET-CT. Participants will have two scans, one 60 minutes after injection and another scan 150 minutes after injection. Each scan will take 10-20 minutes.
[68Ga]Ga-A9-5209 will be administered at 2 MBq/kg by a nuclear medicine technologist, a study nurse, or by an investigator.
Part 1: 10 participants evaluating tumour uptake, biodistribution and dosimetry
Part 2: Up to 30 additional participants: a minimum of 4 participants per indication should be included in the study. Target indications are advanced or metastatic breast cancer, prostate cancer, non small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), or mesothelioma.
There will be no differences in the assessments conducted for participants in Parts 1 and 2, the analysis however will differ.
Part 1 participants will be enrolled first, once that cohort is complete then Part 2 participants will be enrolled.
Intervention code [1] 329515 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339382 0
safety and tolerability
Timepoint [1] 339382 0
Vital signs: blood pressure, heart rate determined using oximeter, and oxygen saturation are to be performed at screening, within 30 minutes prior to [68Ga]Ga A9 5209 administration and 30 ± 10 minutes following administration.
Electrocardiogram: resting for at least 5 minutes before measurements; triplicate 12-lead electrocardiogram (2 minutes apart), to be performed during screening and twice on Day 1: within 30 minutes prior to [68Ga]Ga A9 5209 administration and 30 ± 10 minutes following administration.
Hematology, blood chemistry, and urinalysis assessments at Screening and Day 1 pre-dose.
AEs on Day 1 and Day 2
Secondary outcome [1] 439728 0
To determine normal tissue biodistribution and tumour uptake and dosimetry of [68Ga]Ga A9 5209. This a composite secondary outcome.
Timepoint [1] 439728 0
Day 1
Whole Body PET/CT (CT combined with PET imaging will be a low dose):
• Conventional (15 - 30 cm axial) scanners: From skull to thigh (with extension to feet per Investigator discretion); static scans at 60 + 10 min, 150 + 10 min post [68Ga]Ga A9 5209 injection.
• Long axial field of view (LAFOV) (>100 cm) scanners: 60 + 10 min, and 120 + 10 min post [68Ga]Ga A9 5209 injection, with an optional dynamic scan (0 – 30 minutes) and an optional scan time point of 180 ± 10 min post injection.
Venous blood samples will be taken just prior to each scan that is performed. and again within 10 minutes following the scan.
Secondary outcome [2] 440568 0
To assess the level of correlation between [68Ga]Ga A9 5209 and [18F]Fluorodeoxyglucose (FDG)- positron emission tomography (PET) and/or [68Ga]Ga-PSMA-11-PET (or [18F]DCFPyL-PET or equivalent) and computed tomography (CT) scans
Timepoint [2] 440568 0
Day 1
Whole Body PET/CT (CT combined with PET imaging will be a low dose):
• Conventional (15 - 30 cm axial) scanners: From skull to thigh (with extension to feet per Investigator discretion); static scans at 60 + 10 min, 150 + 10 min post [68Ga]Ga A9 5209 injection.
• Long axial field of view (LAFOV) (>100 cm) scanners: 60 + 10 min, and 120 + 10 min post [68Ga]Ga A9 5209 injection, with an optional dynamic scan (0 – 30 minutes) and an optional scan time point of 180 ± 10 min post injection.

Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed advanced or metastatic breast cancer, prostate cancer, NSCLC, SCLC, or mesothelioma
2. Willing to provide an archival tumour sample, if available, for B1R immunohistochemistry
3. Age 18 years old or older
4. Mentally competent and able to understand and sign the Informed Consent Form
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
6. Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST 1.1): Participants with bone-only disease evaluable by PSMA-PET and/or FDG-PET may be included in the study after discussion with the Medical Monitor.
7. 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 administration of investigational product
b. Symptoms are stable and steroid/antiepileptic doses remain unchanged for a minimum of 4 weeks
8. At least 4 weeks from prior major surgery
9. 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 6 months following exposure to the investigational product.
10. Laboratory values at screening must be as follows:
a. Hematology:
i. Absolute neutrophil count greater than 1,000 cells/mm3
ii. Platelet count greater than 75,000 cells/mm3
iii. Haemoglobin greater than or equal to 8 g/dL (4.96 mmol/L): Transfusion is acceptable to meet this criterion but not within 7 days before administration of investigational product.
b. Renal:
i. Creatinine clearance greater than or equal to 40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation
c. Coagulation:
i. International normalized ratio (INR) must be less than 1.5 × upper limit of normal (ULN)
d. Liver:
i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 × ULN or less than or equal to 5 × 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
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
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 a peptide-based imaging or therapeutic agent or any excipient present in [68Ga]Ga-A9-5209
4. Cardiovascular exclusions:
a. A medical condition that, in the opinion of the Investigator, could interfere with the administration of diagnostic agent or assessment of toxicity
b. Clinically significant cardiac disease not controlled on medical therapy (e.g., congestive cardiac failure, arrhythmia, coronary heart disease)
c. History of myocardial infarction or unstable angina within 6 months before Day 1
5. Other exclusions:
a. Previous enrollment in this study
b. Concomitant treatment with a radiopharmaceutical agent
6. Prior External Beam Radiation Therapy (EBRT) comprising a volume > 25% of the bone marrow
7. Recent medical concerns exclusions:
a. Uncontrolled bleeding or a bleeding diathesis within 7 days prior to Day 1
b. Serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture within 7 days prior to Day 1
c. 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 after discussion with the Medical Monitor.
9. 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
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Sample Size Determination
The sample size in this study is not based on formal statistical hypothesis testing. The number of participants is based on safety and feasibility and is similar to other dosimetry studies. All analysis will be descriptive in this open-label, single-arm trial. Summaries of safety, biodistribution and dosimetry will be summarized by incidence, median, mean, and 95% confidence interval (CI).
Safety Analysis
Data will be graded according to CTCAE v5.0 (or higher) and coded using the Medical Dictionary for Regulatory Activities (MedDRA) v25.0 or higher. Frequencies and percentages of participants with treatment-emergent adverse events (TEAEs) will be summarized by system organ class and preferred term for all TEAEs, treatment related TEAEs, TEAEs by maximal grade, Grade 3 TEAEs, serious TEAEs, TEAEs leading to death.
Summary tables will include the number and proportion of participants experiencing an adverse event and the number of adverse events. An AE is treatment emergent if it occurs or worsens after the first dose of study treatment. Descriptive statistics (e.g., arithmetic mean, standard deviation, median, minimum, and maximum) will be calculated for continuous safety data, while frequency summary (e.g., number of observed and percentage of each category) will be applied for categorical safety data.
Clinical laboratory tests, electrocardiograms, and vital signs will be listed and summarized. Clinically significant laboratory abnormalities and physical examination findings will be captured as AEs.
Biodistribution and Dosimetry
The site and intensity of [68Ga]Ga-A9-5209 uptake, mean, and maximum SUV in tumour lesions assessed by PET/CT. A comparison to [18F]FDG -PET/CT and/or PET/CT with either [68Ga]Ga-PSMA-11 or [18F]F-PSMA-I&T will be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/12/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2026
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 317417 0
Commercial sector/Industry
Name [1] 317417 0
Alpha-9 Theranostics
Country [1] 317417 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Alpha-9 Theranostics
Address
Country
Australia
Secondary sponsor category [1] 319700 0
None
Name [1] 319700 0
Address [1] 319700 0
Country [1] 319700 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316137 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 316137 0
https://bellberry.com.au/
Ethics committee country [1] 316137 0
Australia
Date submitted for ethics approval [1] 316137 0
18/09/2024
Approval date [1] 316137 0
07/11/2024
Ethics approval number [1] 316137 0

Summary
Brief summary
This study aims to assess the safety, tolerability, tumour uptake, biodistribution and dosimetry of a new tumour imaging agent, [68Ga]Ga-A9-5209, in patients with advanced or metastatic cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above with advanced or metastatic breast cancer, prostate cancer, non-small cell lung cancer, small cell lung cancer or mesothelioma.

Study details
All participants who choose to consent in this study will undergo a screening visit to assess their eligibility. Participants will receive a single administration of [68Ga]Ga-A9-5209 via intravenous injection on Day 1. Participants will receive up to four PET/CT scans, and four blood draws (one for each scan) on Day 1. Participants will complete a safety follow up visit/end of study visit on Day 2.
Patients with advanced or metastatic breast cancer, prostate cancer, NSCLC, SCLC, or mesothelioma can participate in either Part 1 or Part 2 of this study. There will be no differences in the assessments conducted for participants in Parts 1 and 2, the analysis however will differ.
Part 1 participants will be evaluated for tumour uptake, biodistribution and dosimetry of [68Ga]Ga-A9-5209.
Part 2 participants will be evaluated for tumour uptake. A minimum of 4 participants per indication will be included in the study. Target indications are advanced or metastatic breast cancer, prostate cancer, non small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), or mesothelioma.
If successful, this potential new product could provide more accurate tumour staging and treatment response evaluation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136906 0
Prof Rodney Hicks
Address 136906 0
Melbourne Theranostic Innovation Centre, Level 8/14-20 Blackwood St, North Melbourne VIC 3051
Country 136906 0
Australia
Phone 136906 0
+6139454 5800
Fax 136906 0
Email 136906 0
[email protected]
Contact person for public queries
Name 136907 0
Ovid Trifan
Address 136907 0
Alpha-9 Theranostics Australia Pty Ltd. 185 Dartmouth St, 6th Floor Boston, MA 02116
Country 136907 0
United States of America
Phone 136907 0
+16174588411
Fax 136907 0
Email 136907 0
[email protected]
Contact person for scientific queries
Name 136908 0
Ovid Trifan
Address 136908 0
Alpha-9 Theranostics Australia Pty Ltd.,185 Dartmouth St, 6th Floor Boston, MA 02116
Country 136908 0
United States of America
Phone 136908 0
+16174588411
Fax 136908 0
Email 136908 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


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.