Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Lead-212 PSV359 Therapy for Patients With Solid Tumors

A 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

Lead-212 PSV359 Therapy for Patients With Solid Tumors (NCT06710756) is a Phase 1 / Phase 2 interventional studying Pancreatic Ductal Adenocarcinoma and Gastric Cancer, sponsored by Perspective Therapeutics. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Pancreatic Ductal Adenocarcinoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 112 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Pancreatic Ductal Adenocarcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

[203Pb]Pb-PSV359

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

DRUG

[212Pb]Pb-PSV359

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

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Biogenix

Miami, Florida, United States

University of Kentucky

Lexington, Kentucky, United States

Saint Louis University

St Louis, Missouri, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Ohio State University

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06710756), the sponsor (Perspective Therapeutics), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06710756 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06710756?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06710756?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06710756. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06710756. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.