NCT06710756 · Perspective Therapeutics
Lead-212 PSV359 Therapy for Patients With Solid Tumors
What this study is about
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.
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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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Miami, Florida
- Kansas City, Kansas
- Lexington, Kentucky
- Rochester, Minnesota
- St Louis, Missouri
- Omaha, Nebraska
- Columbus, Ohio
- Pittsburgh, Pennsylvania
- Houston, Texas
- Madison, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations