RECRUITING

Lead-212 PSV359 Therapy for Patients With Solid Tumors

Conditions

Pancreatic Ductal Adenocarcinoma Gastric Cancer Esophageal Cancer Colorectal Cancer Ovarian Cancer Head and Neck Cancer Sarcoma Mesothelioma Fibroblast Activation Protein Solid tumor malignancy Theronostic Radiopharmaceutical Radiotherapy Alpha Particle Pb-203 Pb-212

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-04-28

Study Completion:2032-05-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06710756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

ClinicalTrials at Perspectivetherapeutics

CONTACT

(206) 676-0900

clinicaltrials@perspectivetherapeutics.com

Study Locations (Sites)

Saint Louis University

St Louis, Missouri, 63110

United States

Nebraska Cancer Specialists

Omaha, Nebraska, 68130

United States

Collaborators and Investigators

Sponsor: Perspective Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-28

Study Completion Date2032-05-28

Study Record Updates

Study Start Date2025-04-28

Study Completion Date2032-05-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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