Targeted therapy using Lead-212 for solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• VA Greater Los Angeles Healthcare System
  Los Angeles, California, United States Recruiting
• UCLA Department of Medicine - Hematology/Oncology
  Los Angeles, California, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• Biogenix
  Miami, Florida, United States Recruiting
• University of Kansas
  Kansas City, Kansas, United States Recruiting
• University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Study coordinator: ClinicalTrials at Perspectivetherapeutics
• Email: clinicaltrials@perspectivetherapeutics.com
• Phone: (206) 676-0900

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Virtual exercise program to preserve function and prevent disability during chemotherapy

  This trial tests whether supervised resistance sessions by video plus short home aerobic workouts help adults 18–64 maintain strength and stay active while receiving curative-intent chemotherapy.

  Recruiting at 29 sites Alliance for Clinical Trials in Oncology · Dublin, California and 29 other locations · NCT07059884

• IDOV-Immune for advanced solid tumors

  This trial will try a single IV infusion of an engineered oncolytic vaccinia virus called IDOV-Immune in adults with advanced solid tumors that no longer respond to standard treatments.

  Recruiting at 5 sites Phase 1 ViroMissile, Inc. · St Louis, Missouri and 4 other locations · NCT06910657

• Using Riluzole to Help Breast Cancer Survivors with Cognitive Issues

  This study is testing if the medication riluzole can help breast cancer survivors who are having trouble with thinking and memory feel better.

  Recruiting Phase 2 University of California, Irvine · Orange, California · NCT06580002

• Using a new imaging agent to detect various cancers

  This study is testing a new imaging agent to see if it can better detect certain cancers in adults compared to standard imaging methods.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06503146

• Testing MDX2001 for advanced solid tumors

  This study is testing a new drug called MDX2001 to see if it can safely help people with advanced solid tumors like breast or colon cancer.

  Recruiting at 6 sites Phase 1/2 ModeX Therapeutics, An OPKO Health Company · Denver, Colorado and 5 other locations · NCT06239194

• Validation of a blood test for early cancer detection and monitoring

  This study is testing a blood test to see if it can help find different types of cancer early and monitor patients after treatment.

  Recruiting at 3 sites Adela, Inc · Duarte, California and 16 other locations · NCT05366881

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.