Targeted therapy using Lead-212 for solid tumors
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
PHASE1; PHASE2 · Perspective Therapeutics · NCT06710756
This study is testing a new targeted radiation treatment for patients with solid tumors that have a specific protein to see if it can effectively treat their cancer while protecting healthy tissue.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Perspective Therapeutics (industry) |
| Drugs / interventions | radiation |
| Locations | 7 sites (Miami, Florida and 6 other locations) |
| Trial ID | NCT06710756 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a peptide-based radiopharmaceutical, Lead-212 PSV359, in patients with solid tumors that express Fibroblast Activation Protein (FAP). The study is divided into two parts: a dose-escalation phase to determine the maximum tolerated dose and a dose-expansion phase to further assess the identified doses. Patients will undergo imaging to confirm FAP expression and will receive escalating doses of the treatment to evaluate its therapeutic potential. The trial aims to improve targeted radiation delivery to cancerous tissues while minimizing exposure to healthy tissues.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with locally advanced or metastatic solid tumors that have shown progression despite standard therapies.
Not a fit: Patients with known brain metastases or active secondary malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new targeted treatment option for patients with advanced solid tumors.
How similar studies have performed: Other studies using targeted alpha-particle therapies have shown promise, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Miami, Florida and 6 other locations
- Biogenix — Miami, Florida, United States (RECRUITING)
- University of Kentucky — Lexington, Kentucky, United States (RECRUITING)
- Saint Louis University — St Louis, Missouri, United States (RECRUITING)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (RECRUITING)
- Ohio State University — Columbus, Ohio, United States (RECRUITING)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: ClinicalTrials at Perspectivetherapeutics
- Email: clinicaltrials@perspectivetherapeutics.com
- Phone: (206) 676-0900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Ductal Adenocarcinoma, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Ovarian Cancer, Head and Neck Cancer, Sarcoma, Mesothelioma