Lead-212 PSV359 Therapy For Patients With Solid Tumors

Study Overview

Lead-212 PSV359 Therapy for Patients With Solid Tumors

Phase I/IIa clinical study evaluating the safety and efficacy of peptide-based theranostic (therapeutic and diagnostic) radiopharmaceuticals, i.e. [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 targeting Fibroblast Activation Protein in subjects with solid tumors.

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-study 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.

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

DRUG: [203Pb]Pb-PSV359
DRUG: [212Pb]Pb-PSV359

PSV359-001

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	Results Reporting Dates	Study Record Updates
First Submitted 2024-11-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-20
First Submitted that Met QC Criteria 2024-11-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-23
First Posted (ACTUAL) 2024-11-29	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dose Escalation * Enrolled subjects are administered [203Pb]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers. * Enrolled subjects are administered [212Pb]Pb-PSV359 (starting at 2.5 mCi upto 10 mCi) for treatment of FAP-expressing cancers and for determining Recommende	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.
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	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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Dose Escalation

* Enrolled subjects are administered [203Pb]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers. * Enrolled subjects are administered [212Pb]Pb-PSV359 (starting at 2.5 mCi upto 10 mCi) for treatment of FAP-expressing cancers and for determining Recommende

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.

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

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.

Primary Outcome Measures	Measure Description	Time Frame
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	Up to 3 years
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	Up to 3 years
Determination of an antitumor efficacy of [212Pb]Pb-PSV359	The objective response rate (proportion of subjects with complete response or partial response) in dose expansion cohort for subjects receiving at least 1 administration of [212Pb]Pb-PSV359 is determined	Up to 3 years

Secondary Outcome Measures	Measure Description	Time Frame
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	Up to 3 years
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	Up to 3 years
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.	Up to 3 years
Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359	Blood radioactivity pharmacokinetic parameter such as peak plasm concentration (Cmax) is determined	Up to 3 years
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	Up to 3 years
Estimation of biodistribution of 203Pb PSV 359 using SPECT/CT scans	Activity in tumor(s) and organs as percentage of injected dose is assessed	Up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: ClinicalTrials at Perspectivetherapeutics

Phone Number: (206) 676-0900

Email: clinicaltrials@perspectivetherapeutics.com

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:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record

Study Overview

Study Record Dates

Study Plan

Design Details

Contacts and Locations

Participation Criteria

Collaborators and Investigators

Publications

About

Events

Fundraising

Contact Us

Learn

Resources

Patients

Caregivers

Learn

Resources

PatientS

Caregivers

Clinical Trial Record