Lead-212 PSV359 Therapy for Patients With Solid Tumors

NCT06710756 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PSV359-001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 7

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; Sarcoma; Mesothelioma; Head and Neck Cancer

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

Outcome Measures

Primary Outcomes (3)

• 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

  30 days (±1day) post dose

• 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

• 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

  Up to approximately 6 months

Secondary Outcomes (6)

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

  Up to 3 years

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

  Up to 3 years

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

  Up to approximately 3 yrs

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

  up to approximately 3 years

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

  up to approximately 3 years

Study Arms (2)

Dose Escalation

EXPERIMENTAL

* 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.

Drug: [203Pb]Pb-PSV359; Drug: [212Pb]Pb-PSV359

Dose Expansion

EXPERIMENTAL

* 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; Drug: [212Pb]Pb-PSV359

Interventions

[212Pb]Pb-PSV359 DRUG

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

Dose Escalation; Dose Expansion

[203Pb]Pb-PSV359 DRUG

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

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Perspective Therapeutics: lead

Study Sites (7)

Biogenix

Miami, Florida, 33165, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Saint Louis University

St Louis, Missouri, 63110, United States

RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43221, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Head and Neck Neoplasms; Sarcoma; Mesothelioma

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Esophageal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms, Mesothelial

Central Study Contacts

ClinicalTrials at Perspectivetherapeutics

CONTACT

(206) 676-0900; clinicaltrials@perspectivetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: April 28, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): May 28, 2032
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (7)