A Phase 1 Study Investigating the Safety, Biodistribution, and Dosimetry of [68Ga]Ga-A9-6217 in Participants with Select Advanced or Metastatic Solid Tumors

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.