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Pancreatic Ductal AdenocarcinomaPhase 1/2NCT06710756

Lead-212 PSV359 Therapy for Patients With Solid Tumors

A Phase 1/2 study testing [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in people with Pancreatic Ductal Adenocarcinoma and Gastric Cancer, run by Perspective Therapeutics at 16 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
[203Pb]Pb-PSV359 and [212Pb]Pb-PSV359
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
16 sitesUnited States
Study dates
28 Apr 2025to 28 May 2032
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

ClinicalTrials at Perspectivetherapeutics contact

(206) 676-0900

clinicaltrials@perspectivetherapeutics.com

16 sites in 1 country

United States16 sites, 16 recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Cancer Answer Line, 866-223-8100, kolliar@ccf.org

    Elcin Zan, MD

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43221

    Pierce Burris, 1-614-685-0720, pierce.burris@osumc.edu

    Vineeth Sukrithan, MD

    Recruiting

  • UT Southwestern University Hospital Radiology Clinic

    Dallas, Texas, 75390

    Radiology Clinical Research Center, 214-645-1568, RCRO@UTSouthwestern.edu

    Orhan K Oz, MD, PhD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Brian Briones, 832-266-3892, bbbriones@mdanderson.org

    Yang Lu, MD, PhD

    Recruiting

  • University of Kansas

    Kansas City, Kansas, 66205

    KUCC Nurse Navigation, (913) 945-7752, CTNurseNav@kumc.edu

    Raed Al-Rajabi, M.D.

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Sarah Martin, 859-323-6837, SarahC.Martin@uky.edu

    Denise Fabian, MD

    Recruiting

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

    Janake Wijesuriya, 310-977-5209, Janake.Wijesuriya@va.gov

    Gholam R Berenji, MD

    Recruiting

  • UCLA Department of Medicine - Hematology/Oncology

    Los Angeles, California, 90095

    Lim Christopher, 310-633-8400 ext. 16043, christopherlim@mednet.ucla.edu

    Lee S Rosen, MD

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Cancer Connect, (800) 622-8922, clinicaltrials@cancer.wisc.edu

    Grace Blitzer, M.D.

    Recruiting

  • University of Miami

    Miami, Florida, 33125

    Sandel Cepero, 305-243-6855, s.cepero@miami.edu

    Emily Jonczak, MD

    Recruiting

  • Biogenix

    Miami, Florida, 33165

    Jerry Joseph, 1-786-719-1799, jjoseph@cira-health.com

    Julio Cordero

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York, 10065

    Daisy Yascaribay, 332-229-1096, yascard@mskcc.org

    Lisa Bodei, MD, PhD

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Hanna Kurz, (402) 691-6974, hkurz@nebraskacancer.com

    Samuel Mehr, M.D.

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

    Eunice Acampado, 412-623-1322, acampadoem@upmc.edu

    Ravi Patel, MD, PhD

    Recruiting

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, 55905

    Cancer Center Clinical Trials Referral Office, (855) 776-0015, MAYOCLINICCANCERSTUDIES@mayo.edu

    Thorardur R Halfdanarson, M.D.

    Recruiting

  • Saint Louis University

    St Louis, Missouri, 63110

    Anna Scannell, anna.scannell@health.slu.edu

    Medhat Osman, MD

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

This is a prospective, multi-center open label dose finding, dose expansion study of [212Pb]Pb-PSV359 in subjects with a positive Fibroblast Activation Protein (FAP) imaging scan with imaging agent.

FAP is specifically expressed on the surface of cancer-associated fibroblasts in some tumor tissues and therefore is an attractive target in the diagnosis and treatment of various cancers. Lead-212 ([212Pb]Pb-) based peptide-radiopharmaceuticals are an emerging class of targeted alpha-particle cancer therapies that have potential to improve delivery of a highly effective form of radiation.

This study will be conducted in 2 parts:

Part 1: Dose-escalation: [212Pb]Pb-PSV359 is administered in escalating doses to determine the Maximum Tolerated radioactivity (MTD) Dose and potential recommended Phase 2 dose (RP2D).

Part 2: Dose-expansion: This part will enroll subjects in expansion cohorts based on the identified MTD and RP2D for the selection of [212Pb]Pb-PSV359 doses for further clinical development.

A Dosimetry sub-set utilizing an imaging surrogate, [203Pb]Pb-PSV359, has been incorporated into the study in order to assess organ biodistribution and tumor uptake of the investigational products. This sub study will also estimate radiation dosimetry and correlate uptake of the investigation products with observed toxicities and efficacy.

Being tested
[203Pb]Pb-PSV359, [212Pb]Pb-PSV359
Keywords
Fibroblast Activation Protein, Solid tumor malignancy, Gastric cancer, Esophageal cancer, Colorectal cancer, Ovarian cancer, Head and neck cancer, Theronostic, Radiopharmaceutical, Radiotherapy, Alpha Particle, Pb-203, Pb-212
Medical subject headings
Stomach Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms, Ovarian Neoplasms, Head and Neck Neoplasms, Sarcoma, Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [203Pb]Pb-PSV359Drug

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

  • [212Pb]Pb-PSV359Drug

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

Study groups in NCT06710756
Study groupRoleWhat they receive
Dose EscalationExperimental* Enrolled subjects are administered [203Pb]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers. * Approximately Four cohorts of [212Pb]Pb-PSV359 dose levels will be explored for determining Recommended Phase 2 Dose (RP2D). Study subjects will be assigned to cohorts sequentially.
Receives: Drug: [203Pb]Pb-PSV359; Drug: [212Pb]Pb-PSV359
Dose ExpansionExperimental* Enrolled subjects are administered [203Pb]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers. * Enrolled subjects are administered [212Pb]Pb-PSV359 (RP2D determined previously) for treatment of FAP-expressing cancers
Receives: Drug: [203Pb]Pb-PSV359; Drug: [212Pb]Pb-PSV359

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of safety and tolerability of [203Pb]Pb-PSV359

    Incidence and severity of treatment-related adverse events following a single administration of [203Pb]Pb-PSV359 is determined

    Measured: 30 days (±1day) post dose

  2. Determination of safety and tolerability of [212Pb]Pb-PSV359

    Incidence and severity of treatment-related adverse events following a single and each repeated administration of [212Pb]Pb-PSV359 is determined

    Measured: Up to 3 years

  3. To determine the recommended phase 2 dose of [212Pb]Pb-PSV359

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

    Measured: Up to approximately 6 months

Secondary outcomes (6)

  1. Determination of duration of response following treatment with [212Pb]Pb-PSV359

    Median duration of response for subjects receiving at least 1 administration of [212Pb]Pb-PSV359 is assessed by RECIST V1.1 criteria

    Measured: Up to 3 years

  2. Determination of progression free survival following treatment with [212Pb]Pb-PSV359

    Progression free survival for subjects receiving at least 1 administration of [212Pb]Pb-PSV359 is assessed by RECIST V1.1 criteria

    Measured: Up to 3 years

  3. Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359

    Blood radioactivity pharmacokinetic parameter such as area under the plasma concentration versus time curve (AUC) is determined.

    Measured: Up to approximately 3 yrs

  4. Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359

    Blood radioactivity pharmacokinetic parameter such as peak plasm concentration (Cmax) is determined

    Measured: up to approximately 3 years

  5. Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359

    Blood radioactivity pharmacokinetic parameter such as the time (Tmax) to reach the maximum concentration (Cmax) is determined

    Measured: up to approximately 3 years

  6. Estimation of biodistribution of 203Pb PSV 359 using SPECT/CT scans

    Activity in tumor(s) and organs as percentage of injected dose is assessed

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start28 Apr 2025
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion28 May 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06710756
Sponsor's protocol ID
PSV359-001
Status last verified
Oct 2026
First submitted
25 Nov 2024
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Fabian D, Levy MS, Piecoro DW, Napier D, Miller RW, Kunos CA. Cancer-associated fibroblast activation protein in Appalachian women with uterine cervix cancer. Front Oncol. 2026 Jun 1;16:1799494. doi: 10.3389/fonc.2026.1799494. eCollection 2026.

    PubMed 42306799

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in people with Pancreatic Ductal Adenocarcinoma and Gastric Cancer, run by Perspective Therapeutics at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ClinicalTrials at Perspectivetherapeutics ((206) 676-0900, clinicaltrials@perspectivetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of safety and tolerability of [203Pb]Pb-PSV359 (time frame: 30 days (±1day) post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06710756, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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