Phase 1 64Cu-DOTA-A2DM PET: PSCA-targeted immunoPET tracer (anti-PSCA scFv-Fc2)

This Phase 1 City of Hope study evaluates whether 64Cu-DOTA-A2 scFv-Fc2 DM (64Cu-DOTA-A2DM) can safely and feasibly generate high-quality PET images in locally advanced or metastatic, unresectable PSCA-expressing pancreatic cancer. The intervention is an anti-PSCA antibody fragment (scFv-Fc2) engineered for faster clearance (A2DM double-mutant) and chelated with DOTA to carry copper-64 for PET imaging—an “immunoPET” approach meant to visualize PSCA-positive disease noninvasively. Participants receive unlabeled DOTA-A2DM IV followed hours later by 64Cu-labeled 64Cu-DOTA-A2DM, then undergo PET imaging over the next 1–2 days, with serial blood/urine sampling for pharmacokinetics and safety. The scientific angle is companion-style target imaging in a tumor where biopsy can be difficult and where PSCA is expressed in a substantial subset of pancreatic tumors (~60–80% in published clinical-pathology series). Today’s care for locally advanced/metastatic pancreatic adenocarcinoma is systemic chemotherapy (modified FOLFIRINOX or gemcitabine/nab-paclitaxel), with biomarker-driven options (e.g., PARP inhibition for germline BRCA) and clinical trials; this study explores whether PSCA-PET can better map target expression and disease extent for future PSCA-directed therapies.