Lead-212 PSV359 Therapy for Patients With Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Pancreatic Ductal Adenocarcinoma, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Ovarian Cancer, Head and Neck Cancer, Sarcoma, Mesothelioma

In brief

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 facts

Study ID

NCT06710756

Run by

Perspective Therapeutics

People needed

112

Starts

2025-04-28

Expected to finish

2032-05-28

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• University of Miami — Miami, Florida, United States (enrolling)
• Biogenix — Miami, Florida, United States (enrolling)
• University of Kansas — Kansas City, Kansas, United States (enrolling)
• University of Kentucky — Lexington, Kentucky, United States (enrolling)
• Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States (enrolling)
• Saint Louis University — St Louis, Missouri, United States (enrolling)
• Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• University of Wisconsin — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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