A Phase 1, First-in-human Single Photon Emission Computed Tomography (SPECT) Imaging Study to Assess [203Pb]Pb-AB102 in Participants with Advanced Solid Tumours

Intervention Drug #1: [203Pb]Pb-AB102 Participants will receive a single intravenous (IV) solus bolus injection of [203Pb]Pb-AB102. The radioactivity is 315-400MBq and 10ml in volume, the dose is the same for all participants (360MBq) and may be adjusted at Sponsor discretion based off scan quality. The study imaging agent will be administered by authorised and appropriately trained site personnel in the Nuclear Medicine department, under the supervision of the Investigator. [203Pb]Pb-AB102 is administered as a slow IV injection (not exceeding 15 minutes) during Imaging Period 1 (Day 1). As the study intervention is administered on-site by qualified personnel, adherence is ensured through direct administration and source documentation. The protocol requires recording of the date, time and dose administered. Drug administration records are maintained to document compliance. SPECT/CT Imaging The SPECT/CT component involves acquisition of SPECT images together with low-dose CT images following administration of [203Pb]Pb-AB102. The imaging is performed to evaluate the biodistribution and tumour lesion uptake of the investigational imaging agent. Participants undergo one [203Pb]Pb-AB102 imaging period following a single administration of the investigational imaging agent, the scans are 1.5 hours, 8 hours and 24 hours after injection. The imaging period includes 3 SPECT/CT acquisitions over two days following injection. SPECT/CT imaging is performed at the participating site's Nuclear Medicine Department using standard clinical SPECT/CT imaging equipment. The SPECT/CT scans will be performed by appropriately qualified Nuclear Medicine Technologists and Nuclear Medicine staff in accordance with local site procedures and under the supervision of the Investigator and Nuclear Medicine Physician. As all imaging procedures are conducted on-site under direct supervision, adherence is ensured through completion of required imaging procedures. Imaging completion and acquisition details are documented in source records and the eCRF. Intervention Drug #2 – [68Ga]Ga-AB101 Participants will receive a single intravenous (IV) administration of [68Ga]Ga-AB101 at 2MBq/kg up to a maximum of 200MBq at 10ml. This component of the trial occurs at least 5 days after the [203Pb]Pb-AB102 administration, participation is optional and determined by the participant, it requires an additional consent form to be signed as part of the trial. The study imaging agent will be administered by authorised and appropriately trained site personnel in the Nuclear Medicine Department, under the supervision of the Principal Investigator. [68Ga]Ga-AB101 is administered as a slow IV injection (not exceeding 15 minutes) during the Imaging Period 2 (after the SPECT scan). As the study intervention is administered on-site by qualified study personnel, adherence is ensured through direct administration and source documentation. The date, time and dose administered are recorded in source documents and the electronic case report form (eCRF), and drug administration records are maintained to document compliance. PET/CT Imaging The PET/CT component involves acquisition of PET images together with CT images following administration of [68Ga]Ga-AB101. The imaging is performed to identify and evaluate P-cadherin-expressing lesions and to assess tumour uptake of the investigational imaging agent. Participants undergo one [68Ga]Ga-AB101 PET/CT imaging period following a single administration of [68Ga]Ga-AB101, the scan is 1 hour after injection. The PET/CT imaging period occurs on a single study day and may include protocol-specified image acquisitions associated with that visit. PET/CT imaging is performed at the participating site's Nuclear Medicine Department using standard clinical PET/CT imaging equipment. The PET/CT scans will be performed by appropriately qualified Nuclear Medicine Technologists/Radiographers and Nuclear Medicine staff in accordance with local site procedures and under the supervision of the Investigator and Nuclear Medicine Physician, where applicable. As all imaging procedures are conducted on-site under direct supervision, adherence is ensured through participant attendance at scheduled imaging visits and completion of required imaging procedures. Imaging completion and acquisition details are documented in source records and the eCRF.