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Lead-212 PSV359 Therapy for Solid Tumors

This study is testing a new treatment called [212Pb]Pb-PSV359 for solid tumors like pancreatic, stomach, esophageal, colorectal, and ovarian cancers. This treatment targets a protein called Fibroblast Activation Protein (FAP) found on some cancer cells. Before treatment, you'll receive a small amount of [203Pb]Pb-PSV359 for imaging to confirm your tumor has FAP. The main goals are to see how safe [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 are, and to find the best dose of [212Pb]Pb-PSV359. You might be able to join if you are 18 to 90 years old, have good organ function, and your cancer has progressed despite standard treatments or if no standard treatment exists. The study plans to enroll 112 people.

Study design
This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It is designed to find the right dose of [212Pb]Pb-PSV359 and then expand to test that dose in more participants.
What's involved
You would receive an intravenous bolus injection of [203Pb]Pb-PSV359 for imaging, followed by intravenous infusions of [212Pb]Pb-PSV359 for treatment. Safety will be checked for up to 3 years.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability to [203Pb]Pb-PSV359 will be checked around 30 days after your dose. Your safety and tolerability to [212Pb]Pb-PSV359 will be checked for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06710756

Lead-212 PSV359 Therapy for Patients With Solid Tumors

Recruiting
PHASE1Ages 18–90InterventionalTreatment
Perspective Therapeutics
~112 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:[203Pb]Pb-PSV359[212Pb]Pb-PSV359

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determination of safety and tolerability of [203Pb]Pb-PSV359
Measured over 30 days (±1day) post dose
+2 more outcomes measured

Conditions

Pancreatic Ductal Adenocarcinoma
Gastric Cancer
Esophageal Cancer
Colorectal Cancer
Ovarian Cancer
Head and Neck Cancer
Sarcoma
Mesothelioma

Explore related trials

Colorectal CarcinomaEsophageal CarcinomaGastric CarcinomaMalignant Head and Neck NeoplasmMalignant Ovarian NeoplasmMesothelial NeoplasmPancreatic Ductal AdenocarcinomaSarcomaSolid NeoplasmProlyl Endopeptidase FAP

Where it's being run

11 sites across 10 states
Florida2
Kansas1
Kentucky1
Minnesota1
Missouri1
Nebraska1
Ohio1
Pennsylvania1

Who to contact

ClinicalTrials at Perspectivetherapeutics
[email protected]
(206) 676-0900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Determination of safety and tolerability of [203Pb]Pb-PSV35930 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-PSV359Up 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-PSV359Up to approximately 6 months

    The recommended phase 2 dose as determined by cohort observations and review by the Safety Monitoring Committee