Recruiting
Phase 1
Phase 2

Lead-212

Sponsor:

Perspective Therapeutics

Code:

NCT06710756

Conditions

Pancreatic Ductal Adenocarcinoma

Gastric Cancer

Esophageal Cancer

Colorectal Cancer

Ovarian Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

[203Pb]Pb-PSV359

[212Pb]Pb-PSV359

Study Details

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma

Gastric Cancer

Esophageal Cancer

Colorectal Cancer

Ovarian Cancer

Study ID

NCT06710756

Start date

Apr 28, 2025

Status verified date

Jul, 2026

Completion date

May 28, 2032

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

112 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

  • 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.

experimental: Dose Expansion

  • 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

Interventions

[203Pb]Pb-PSV359

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

[212Pb]Pb-PSV359

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

Primary outcome measure

  • Determination of safety and tolerability of [203Pb]Pb-PSV359 [ Time Frame: 30 days (±1day) post dose ]
  • Determination of safety and tolerability of [212Pb]Pb-PSV359 [ Time Frame: Up to 3 years ]
  • To determine the recommended phase 2 dose of [212Pb]Pb-PSV359 [ Time Frame: Up to approximately 6 months ]

Central Contacts and Locations

Central contacts

ClinicalTrials at Perspectivetherapeutics

(206) 676-0900clinicaltrials@perspectivetherapeutics.com

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33125

Contacts

Sandel Cepero

305-243-6855s.cepero@miami.edu

Principal Investigator:

Emily Jonczak, MD

Biogenix

Recruiting

Miami, Florida, United States, 33165

Contacts

Jerry Joseph

786-719-1799jjoseph@cira-health.com

Principal Investigator:

Julio Cordero

University of Kansas

Recruiting

Kansas City, Kansas, United States, 66205

Contacts

Jesse Garcia

913-945-5165jgarcia34@kumc.edu

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Sarah Martin

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

Principal Investigator:

Denise Fabian, MD

Mayo Clinic in Rochester, Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Cancer Center Clinical Trials Referral Office

855-776-0015mayocliniccancertrials@mayo.edu

Saint Louis University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Anna Scannell

anna.scannell@health.slu.edu

Principal Investigator:

Medhat Osman, MD

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Hanna Kurz

402-691-6974hkurz@nebraskacancer.com

Principal Investigator:

Samuel Mehr, M.D.

Ohio State University

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Pierce Burris

614-685-0720pierce.burris@osumc.edu

Principal Investigator:

Vineeth Sukrithan, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Eunice Acampado

412-623-1322acampadoem@upmc.edu

Principal Investigator:

Ravi Patel, MD, PhD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Brian Briones

832-266-3892bbbriones@mdanderson.org

Principal Investigator:

Yang Lu, MD, PhD

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Cancer Connect

800-622-8922clinicaltrials@cancer.wisc.edu

More Information

Sponsor

Perspective Therapeutics

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Perspective Therapeutics on 2026-07-06.