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Pipeline

PSV359

Overview

PSV359 is a clinical-stage radiopharmaceutical therapy for diagnosing and treating Fibroblast Activation Protein-alpha (FAP) expressing solid tumors. Perspective’s in-house discovery team has developed an optimized peptide targeting FAP-α with potential best-in-class characteristics as demonstrated in preclinical models. PSV359 uses Perspective Therapeutics' proprietary chelator (PSC) to bind Pb-203 for SPECT imaging and Pb-212 for alpha particle therapy.

Development

  • Ongoing multi-center Phase 1/2a dose-escalation/expansion trial (NCT06710756) evaluating [212Pb]PSV359 in patients with advanced FAP-α-positive solid tumors, currently recruiting across the US
  • First patient dosed in April 2025; second cohort dosing initiated in October 2025, with no dose-limiting toxicities reported to date and enrollment progressing
  • Preclinical data demonstrate superior therapeutic effects compared to other FAP-targeted agents; novel peptide design enables robust tumor penetration and ideal clearance
  • First-in-human imaging with [203Pb]PSV359 and [68Ga]VMT02 in FAP-expressing cancers confirms rapid uptake, tumor retention, and fast clearance, highlighting differentiated potential
  • Initial Phase 1 data expected late 2026, with plans for expansion into multiple large solid tumor types underway

[68Ga]PSV377 PET Imaging in Patient with Metastatic Colorectal Cancer

Diagnostic FAP-targeted peptide demonstrates excellent uptake in tumors

Standard of Care
PSV771 MIP
1PSV377 uses the same targeting moiety as PSV359 with a NOTA chelator.
Clinical Collaborator: Xiaowei Ma, M.D., Ph.D., The Second Xiangya Hospital, Central South University, China

Clinical Collaborator

Dr. Xiaowei Ma, MD PhD

The Second Xiangya Hospital, Central South University, China