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 all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
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
Missouri
Saint Louis University
RECRUITING
St Louis
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.~* Approximately Four cohorts of \[212Pb\]Pb-PSV359 dose levels will be explored for determining Recommended Phase 2 Dose (RP2D). Study subjects will be assigned to cohorts sequentially.
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
Related Therapeutic Areas
Sponsors
Leads: Perspective Therapeutics