Lead-212 PSV359 Therapy for Patients With Solid Tumors
This study tests a new radioactive therapy called Lead-212 PSV359 that targets cancer cells in solid tumors, particularly pancreatic cancer. The therapy uses particles to deliver radiation directly to cancer cells that have a specific protein called FAP on their surface. Patients will receive imaging scans to track how the therapy works in their body.
Key Objective:This trial is testing whether Lead-212 PSV359 can effectively shrink or slow the growth of FAP-positive solid tumors, particularly pancreatic cancer, by delivering targeted radiation directly to cancer cells.
Who to Consider:Patients with pancreatic ductal adenocarcinoma or other FAP-positive solid tumors who have limited other treatment options should consider enrolling in this study.
Trial Parameters
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Brief 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.
Eligibility Criteria
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 antifungals or antibiotics in the 3 days prior to enrollment * Known medical condition which would make this protocol unreasonably hazardous for the patient * Existence of any medical or social issues