Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors

This is a first-in-human (FiH), open-label, multicenter, phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, pharmacokinetics (PK), and dosimetry properties of 68Ga-DFC413 and to explore whether 68Ga-DFC413 can be used to identify FAP-expressing lesions in patients with various solid tumors, including metastatic PDAC, NSCLC, ductal and lobular BC, TNBC, CRC, and STS. The study is divided in 2 parts: An imaging characterization part (Part 1) and a comparative assessment part (Part 2). All patients in Part 1 (imaging characterization part) will receive a single administered radioactive dose of 68Ga-DFC413. In Part 2 (comparative assessment part) patients will either receive a single administered radioactive dose of 68Ga-DFC413 followed by a single administered radioactive dose of 68Ga-NNS309; or a single administered radioactive dose of 68Ga-NNS309 followed by 68Ga-DFC413.