A 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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Phase I/IIa clinical study evaluating the safety and efficacy of peptide-based theranostic (therapeutic and diagnostic) radiopharmaceuticals, i.e. \[203Pb\]Pb-PSV359 and \[212Pb\]Pb-PSV359 targeting Fibroblast Activation Protein in subjects with solid tumors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• 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
Locations
United States
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
Contact Information
Primary
ClinicalTrials at Perspectivetherapeutics
clinicaltrials@perspectivetherapeutics.com
(206) 676-0900
Time Frame
Start Date:2025-04-28
Estimated Completion Date:2032-05-28
Participants
Target number of participants:112
Treatments
Experimental: Dose Escalation
* Enrolled subjects are administered \[203Pb\]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers.~* Enrolled subjects are administered \[212Pb\]Pb-PSV359 (starting at 2.5 mCi upto 10 mCi) for treatment of FAP-expressing cancers and for determining Recommended Phase 2 Dose (RP2D)
Experimental: Dose Expansion
* Enrolled subjects are administered \[203Pb\]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers.~* Enrolled subjects are administered \[212Pb\]Pb-PSV359 (RP2D determined previously) for treatment of FAP-expressing cancers