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Recruiting Phase 1/2

Lead-212 PSV359 Therapy for Patients With Solid Tumors

NCT06710756 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2025-04-28
Last updated
2026-10-28

Condition(s) studied

Pancreatic Ductal AdenocarcinomaGastric CancerEsophageal CancerColorectal CancerOvarian CancerHead and Neck CancerSarcomaMesothelioma

Investigational drug(s) / intervention(s)

[203Pb]Pb-PSV359[212Pb]Pb-PSV359

[203Pb]Pb-PSV359: \[203Pb\]Pb-PSV359 is administered by intravenous bolus injection for single-photon emission computed tomography imaging.

[212Pb]Pb-PSV359: \[212Pb\]Pb-PSV359 is administered by intravenous infusion for treatment of FAP expressing cancers.

Study 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

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (16)

FacilityCityRegionStatus
VA Greater Los Angeles Healthcare System Los Angeles California Recruiting
UCLA Department of Medicine - Hematology/Oncology Los Angeles California Recruiting
University of Miami Miami Florida Recruiting
Biogenix Miami Florida Recruiting
University of Kansas Kansas City Kansas Recruiting
University of Kentucky Lexington Kentucky Recruiting
Mayo Clinic in Rochester, Minnesota Rochester Minnesota Recruiting
Saint Louis University St Louis Missouri Recruiting
Nebraska Cancer Specialists Omaha Nebraska Recruiting
Memorial Sloan Kettering Cancer Center - Main Campus New York New York Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Ohio State University Columbus Ohio Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
UT Southwestern University Hospital Radiology Clinic Dallas Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
University of Wisconsin Madison Wisconsin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06710756 on ClinicalTrials.gov ↗ ← All trials in the USA