Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000268448
Ethics application status
Approved
Date submitted
22/01/2025
Date registered
10/04/2025
Date last updated
11/05/2025
Date data sharing statement initially provided
10/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Study Investigating the Safety, Biodistribution, and Dosimetry of [68Ga]Ga-A9-6217 in Participants with Select Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1 Study Investigating the Safety, Biodistribution, and Dosimetry of [68Ga]Ga-A9-6217 in Participants with Select Advanced or Metastatic Solid Tumors
Secondary ID [1] 313783 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
advanced or metastatic breast cancer 336410 0
advanced or metastatic prostate cancer 336411 0
advanced or metastatic non-small cell lung cancer 336412 0
advanced or metastatic small cell lung cancer 336413 0
advanced or metastatic colorectal cancer 336414 0
Condition category
Condition code
Cancer 332930 332930 0 0
Breast
Cancer 332931 332931 0 0
Prostate
Cancer 332932 332932 0 0
Lung - Non small cell
Cancer 332933 332933 0 0
Lung - Small cell
Cancer 332934 332934 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A target activity of 2MBq/kg (maximum dose 200MBq) will be administered once via intravenous injection of A9-6217 prior to the participant receiving 2 mandatory (and up to 2 additional and optional) PET scans in a clinic/outpatient setting.

Participants will be expected to have a Screening CT scan and FDG-PET or PSMA-PET scan.
The on-study post-dose PET scans will be done at the following timepoints after the intervention is administered:
1) 0-30min dynamic scan (optional) - conducted over 30min
2) 60mins (mandatory) - 10-20mins long
3) 120mins or 150mins (mandatory) - 10-20mins long
4) 180mins (optional) - 10-20mins long

A qualified nuclear medicine technologist or nuclear medicine physician will administer the tracer prior to any on-study scans being done.

The participant will provide written consent for the 2 additional/optional scans prior to the scans being done. The Electronic Data Capture (EDC) will capture data on the 2 additional/optional scans completed. Additionally, the central image reviewer will have access to the additional/optional scans.

The screening CT/PET scans will be Standard of Care scans that show measurable disease (as per RECIST 1.1) as requested by the participant's usual physician.
On-study PET scans will be skull to thigh (with extension to the feet, per Investigator discretion).

Assessment of fidelity to the intervention will be done via regular monitoring visits (where source verification of data in the EDC will take place) conducted by qualified Clinical Research Associates.
Intervention code [1] 330370 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340464 0
safety and tolerability
Timepoint [1] 340464 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 6217 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 6217 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] 444175 0
To determine normal tissue biodistribution and tumour uptake and dosimetry of [68Ga]Ga A9 6217. This a composite secondary outcome.
Timepoint [1] 444175 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 6217 injection. • Long axial field of view (LAFOV) (>100 cm) scanners: 60 + 10 min, and 120 + 10 min post [68Ga]Ga A9 6217 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] 444176 0
To assess the level of correlation between [68Ga]Ga A9 6217 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] 444176 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 6217 injection. • Long axial field of view (LAFOV) (>100 cm) scanners: 60 + 10 min, and 120 + 10 min post [68Ga]Ga A9 6217 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 CRC
2. Willing to provide an archival tumor sample, if available, for GRPR immunohistochemistry
3. Age equal to or greater than 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 to 2
6. Measurable disease per Response Evaluation Criteria in Solid Tumors (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 the first 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 2 weeks following exposure to the investigational product
10. Laboratory values at screening must be as follows:
a. Hematology:
i. Absolute neutrophil count equal to 1,000 cells/mm3
ii. Platelet count equal to 75,000 cells/mm3
iii. Hemoglobin 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 equal to 40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation
c. Coagulation:
i. International normalized ratio must be < 1.5 × upper limit of normal (ULN)
d. Liver:
i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) equal to 2.5 × ULN 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
1. 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-A9-6217.
4. Cardiovascular exclusions:
a. A medical condition that the Investigator assesses 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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2025
Actual
Date of last participant enrolment
Anticipated
27/02/2026
Actual
Date of last data collection
Anticipated
27/03/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 26933 0
South Africa
State/province [1] 26933 0

Funding & Sponsors
Funding source category [1] 318249 0
Commercial sector/Industry
Name [1] 318249 0
Alpha-9 Theranostics
Country [1] 318249 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Alpha-9 Theranostics
Address
Country
Australia
Secondary sponsor category [1] 320634 0
None
Name [1] 320634 0
Address [1] 320634 0
Country [1] 320634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316890 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 316890 0
Ethics committee country [1] 316890 0
Australia
Date submitted for ethics approval [1] 316890 0
20/02/2025
Approval date [1] 316890 0
25/03/2025
Ethics approval number [1] 316890 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139330 0
Prof Louise Emmett
Address 139330 0
St. Vincent's Hospital Sydney, 390 Victoria Street, Darlinghurst, Sydney, 2010, NSW
Country 139330 0
Australia
Phone 139330 0
+61 02 8382 1830
Fax 139330 0
Email 139330 0
[email protected]
Contact person for public queries
Name 139331 0
Ovid Trifan
Address 139331 0
Alpha-9 Theranostics USA, Inc. 185 Dartmouth St, 6th Floor Boston, MA 02116
Country 139331 0
United States of America
Phone 139331 0
+16178651004
Fax 139331 0
Email 139331 0
[email protected]
Contact person for scientific queries
Name 139332 0
Ovid Trifan
Address 139332 0
Alpha-9 Theranostics USA, Inc. 185 Dartmouth St, 6th Floor Boston, MA 02116
Country 139332 0
United States of America
Phone 139332 0
+16178651004
Fax 139332 0
Email 139332 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.