Lead-212 PSV359 Therapy for Patients With Solid Tumors
Phase I/IIa image-guided, alpha-particle therapy study of \[203Pb\]Pb-PSV359 and \[212Pb\]Pb-PSV359 in patients with solid tumors that are known to be Fibroblast Activation Protein (FAP)-positive.
| Condition(s) | Pancreatic Ductal Adenocarcinoma, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Ovarian Cancer, Head and Neck Cancer, Sarcoma, Mesothelioma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Phase I/IIa image-guided, alpha-particle therapy study of \[203Pb\]Pb-PSV359 and \[212Pb\]Pb-PSV359 in patients with solid tumors that are known to be Fibroblast Activation Protein (FAP)-positive. |
| Who can participate | Inclusion Criteria: * Aged ≥ 18 years * Satisfactory organ function as determined by laboratory testing * Eastern Cooperative Oncology Group performance (ECOG) status of 0 to 1 * Life expectancy \> 3 months * Progressive disease despite standard therapy or for whom no standard therapy exists * Positive \[203Pb\]Pb-PSV359 SPECT/CT scan showing uptake of \[203Pb\]Pb-PSV359 in at least 1 known lesion on the 1-hour SPECT/ CT scan * Histological, pathological, and/or cytological confirmation of solid tumor malignancy that is locally advanced or metastatic Exclusion Criteria: * Known hypersensitivity to the active agent or any of the excipients * Active secondary malignancy * Pregnancy or breastfeeding a child * Known brain metastases * Known active or uncontrolled infections requiring ongoing a |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Lead sponsor | Perspective Therapeutics |
| Locations | Miami, Florida, United States; Miami, Florida, United States; Lexington, Kentucky, United States; St Louis, Missouri, United States; Omaha, Nebraska, United States; Columbus, Ohio, United States (+2 more sites) |
| Start date | 2025-04-28 |
| NCT ID | NCT06710756 |
| Official listing | https://clinicaltrials.gov/study/NCT06710756 |