Lead-212 PSV359 Therapy for Patients With Solid Tumors

Part of paid clinical trials in Miami, Florida.

Sponsor
Perspective Therapeutics
Study ID
NCT06710756
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • [203Pb]Pb-PSV359 — DRUG
    \[203Pb\]Pb-PSV359 is administered by intravenous bolus injection for single-photon emission computed tomography imaging.
  • [212Pb]Pb-PSV359 — DRUG
    \[212Pb\]Pb-PSV359 is administered by intravenous infusion for treatment of FAP expressing cancers.

Study Details

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.

Key Dates

Start date
Apr 28, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
May 28, 2032

Study Design

Enrollment
112 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Determination of safety and tolerability of [203Pb]Pb-PSV359 [ Time Frame: 30 days (±1day) post dose ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
BiogenixMiamiFlorida33165
Jerry Joseph
[email protected]
786-719-1799
Julio Cordero (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33125
Sandel Cepero
[email protected]
305-243-6855
Emily Jonczak, MD (PRINCIPAL_INVESTIGATOR)
University of KentuckyLexingtonKentucky40536
Sarah Martin
[email protected]
859-323-6837
Denise Fabian, MD (PRINCIPAL_INVESTIGATOR)
Saint Louis UniversitySt LouisMissouri63110
Anna Scannell
[email protected]
Medhat Osman, MD (PRINCIPAL_INVESTIGATOR)
Nebraska Cancer SpecialistsOmahaNebraska68130
Hanna Kurz
[email protected]
402-691-6974
Samuel Mehr, M.D. (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43221
Pierce Burris
[email protected]
614-685-0720
Vineeth Sukrithan, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15232
Eunice Acampado
[email protected]
412-623-1322
Ravi Patel, MD, PhD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Brian Briones
[email protected]
832-266-3892
Yang Lu, MD, PhD (PRINCIPAL_INVESTIGATOR)

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