A Phase 1 Study Investigating the Safety, Biodistribution, and Dosimetry of [68Ga]Ga-A9-6217 in Participants with Select Advanced or Metastatic Solid Tumors
Alpha-9 Theranostics
40 participants
May 30, 2025
Interventional
Conditions
Summary
This study aims to assess the Safety, Biodistribution, and Dosimetry of [68Ga]Ga-A9-6217 in Participants with Select Advanced or Metastatic Solid Tumors. [68Ga]Ga-A9-6217 is a radioactive tracer that is used to assist with visualising potential tumors. 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 colorectal cancer. Study details All participants in this study will be asked to attend a Screening Visit which may need to take place over more than 1 day. Participants deemed eligible following their screening visits will be required to attend a single session that lasts for approximately 6 hours to complete at least 2 full body PET scans, which will include an injection of the tracer ([68Ga]Ga-A9-6217) and collection of blood and urine samples at various timepoints. Participants may be asked to complete 2 additional scans and will then be followed up for 2 days, including general monitoring. It is hoped that this study will help determine if [68Ga]Ga-A9-6217 is a safe and effective tracer that can be used in diagnosis or monitoring of tumours in individuals with cancer.
Eligibility
Inclusion Criteria22
- Histologically or cytologically confirmed advanced or metastatic breast cancer, prostate cancer, NSCLC, SCLC, or CRC
- Willing to provide an archival tumor sample, if available, for immunohistochemistry
- Age equal to or greater than 18 years old
- Mentally competent and able to understand and sign the Informed Consent Form
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
- 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
- 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
- At least 4 weeks from prior major surgery
- 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
- 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
Exclusion Criteria17
- 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.
- Residual toxicity > Grade 1 from prior anticancer therapy (except alopecia and/or fatigue).
- 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.
- 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
- Other exclusions:
- a. Previous enrollment in this study
- b. Concomitant treatment with a radiopharmaceutical agent
- Prior External Beam Radiation Therapy (EBRT) comprising a volume > 25% of the bone marrow.
- 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
- 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.
- Pregnant or lactating.
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Interventions
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.
Locations(1)
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ACTRN12625000268448