Lead-212 PSV359 Therapy for Patients With Solid Tumors

April 28, 2026 updated by: Perspective Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33165
        • Recruiting
        • Biogenix
        • Contact:
        • Principal Investigator:
          • Julio Cordero
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky
        • Contact:
        • Principal Investigator:
          • Denise Fabian, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists
        • Principal Investigator:
          • Samuel Mehr, M.D.
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Vineeth Sukrithan, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University Of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Ravi Patel, MD, PhD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Yang Lu, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 likely to interfere with study conductor that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions
  • Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the investigational product or excipients
  • Major surgery within 21 days prior to the administration of [212Pb]Pb-PSV359; the subject must be sufficiently recovered and stable before treatment administration
  • Diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to enrollment into the study
  • Current abuse of alcohol or illicit drugs
  • Treatment with any live/attenuated vaccine in the 7 days prior to enrollment
  • Previous treatment with any systemic anticancer therapy within 4 weeks prior to treatment on study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: [203Pb]Pb-PSV359
[203Pb]Pb-PSV359 is administered by intravenous bolus injection for single-photon emission computed tomography imaging.
Drug: [212Pb]Pb-PSV359
[212Pb]Pb-PSV359 is administered by intravenous infusion for treatment of FAP expressing cancers.
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.
Drug: [203Pb]Pb-PSV359
[203Pb]Pb-PSV359 is administered by intravenous bolus injection for single-photon emission computed tomography imaging.
Drug: [212Pb]Pb-PSV359
[212Pb]Pb-PSV359 is administered by intravenous infusion for treatment of FAP expressing cancers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of safety and tolerability of [212Pb]Pb-PSV359
Time Frame: Up to 3 years
Incidence and severity of treatment-related adverse events following a single and each repeated administration of [212Pb]Pb-PSV359 is determined
Up to 3 years
Determination of safety and tolerability of [203Pb]Pb-PSV359
Time Frame: 30 days (±1day) post dose
Incidence and severity of treatment-related adverse events following a single administration of [203Pb]Pb-PSV359 is determined
30 days (±1day) post dose
To determine the recommended phase 2 dose of [212Pb]Pb-PSV359
Time Frame: Up to approximately 6 months
The recommended phase 2 dose as determined by cohort observations and review by the Safety Monitoring Committee
Up to approximately 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of duration of response following treatment with [212Pb]Pb-PSV359
Time Frame: Up to 3 years
Median duration of response for subjects receiving at least 1 administration of [212Pb]Pb-PSV359 is assessed by RECIST V1.1 criteria
Up to 3 years
Determination of progression free survival following treatment with [212Pb]Pb-PSV359
Time Frame: Up to 3 years
Progression free survival for subjects receiving at least 1 administration of [212Pb]Pb-PSV359 is assessed by RECIST V1.1 criteria
Up to 3 years
Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359
Time Frame: Up to approximately 3 yrs
Blood radioactivity pharmacokinetic parameter such as area under the plasma concentration versus time curve (AUC) is determined.
Up to approximately 3 yrs
Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359
Time Frame: up to approximately 3 years
Blood radioactivity pharmacokinetic parameter such as peak plasm concentration (Cmax) is determined
up to approximately 3 years
Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359
Time Frame: up to approximately 3 years
Blood radioactivity pharmacokinetic parameter such as the time (Tmax) to reach the maximum concentration (Cmax) is determined
up to approximately 3 years
Estimation of biodistribution of 203Pb PSV 359 using SPECT/CT scans
Time Frame: Up to approximately 3 years
Activity in tumor(s) and organs as percentage of injected dose is assessed
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perspective Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2025

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

May 28, 2032

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSV359-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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