Lead-212 PSV359 Therapy for Patients With Solid Tumors
Start Date
4/28/2025
Completion Date
5/28/2032
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.
Detailed Description
This is a prospective, multi-center open label dose finding, dose expansion study of \[212Pb\]Pb-PSV359 in subjects with a positive Fibroblast Activation Protein (FAP) imaging scan with imaging agent. FAP is specifically expressed on the surface of cancer-associated fibroblasts in some tumor tissues and therefore is an attractive target in the diagnosis and treatment of various cancers. Lead-212 (\[212Pb\]Pb-) based peptide-radiopharmaceuticals are an emerging class of targeted alpha-particle cancer therapies that have potential to improve delivery of a highly effective form of radiation. This study will be conducted in 2 parts: Part 1: Dose-escalation: \[212Pb\]Pb-PSV359 is administered in escalating doses to determine the Maximum Tolerated radioactivity (MTD) Dose and potential recommended Phase 2 dose (RP2D). Part 2: Dose-expansion: This part will enroll subjects in expansion cohorts based on the identified MTD and RP2D for the selection of \[212Pb\]Pb-PSV359 doses for further clinical development. A Dosimetry sub-set utilizing an imaging surrogate, \[203Pb\]Pb-PSV359, has been incorporated into the study in order to assess organ biodistribution and tumor uptake of the investigational products. This sub study will also estimate radiation dosimetry and correlate uptake of the investigation products with observed toxicities and efficacy.
Eligibility Criteria
Age Range: 18 years to 90 years
Interventions
[203Pb]Pb-PSV359
[212Pb]Pb-PSV359
Conditions
Locations
University of Miami
Miami, Florida 33125
United States
Biogenix
Miami, Florida 33165
United States
University of Kansas
Kansas City, Kansas 66205
United States
University of Kentucky
Lexington, Kentucky 40536
United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
United States
Saint Louis University
St Louis, Missouri 63110
United States
Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Ohio State University
Columbus, Ohio 43221
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
University of Wisconsin
Madison, Wisconsin 53792
United States