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

First listed
Nov 29, 2024
Start date
Apr 28, 2025
Status verified
Jul 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 (11)

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 KansasKansas CityKansas66205
Jesse Garcia
[email protected]
913-945-5165
Raed Al-Rajabi, M.D.
University of KentuckyLexingtonKentucky40536
Sarah Martin
[email protected]
859-323-6837
Denise Fabian, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in Rochester, MinnesotaRochesterMinnesota55905
Cancer Center Clinical Trials Referral Office
[email protected]
855-776-0015
Thorardur R Halfdanarson, M.D.
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)
University of WisconsinMadisonWisconsin53792
Cancer Connect
[email protected]
800-622-8922
Grace Blitzer, M.D.

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