Study on Lead-212 PSV359 Therapy for Patients with Solid Tumors

Sponsor: Perspective Therapeutics

Sponsor score: 0

ClinicalTrials ID:NCT06710756

Provider View

This clinical trial is testing a new treatment using a special type of radiation therapy called Lead-212 PSV359, which targets a protein found in some cancer cells. The study aims to find out if this treatment is safe and effective for patients with solid tumors.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new type of treatment that uses a radioactive substance called Lead-212 PSV359. This treatment targets a specific protein found on cancer cells, known as the Fibroblast Activation Protein (FAP). The study is divided into two parts: the first part will test different doses to find the safest and most effective amount, while the second part will expand the study to more patients to further test the treatment's effectiveness. An additional part of the study will use imaging to see how the treatment spreads in the body and how well it targets the cancer.

Description

This study is exploring a new cancer treatment that uses a radioactive substance called Lead-212 PSV359, which targets a protein found on certain cancer cells. The study is being conducted at multiple locations and involves two main parts. In the first part, different doses of the treatment will be tested to find the safest and most effective dose. In the second part, more patients will receive the treatment to further evaluate its effectiveness.

The treatment works by targeting the Fibroblast Activation Protein (FAP), which is found on the surface of cancer cells in some tumors. This makes it a promising target for both diagnosing and treating various cancers. The study also includes a sub-study that uses imaging to see how the treatment spreads in the body and how well it targets the cancer. This will help researchers understand the treatment's safety and effectiveness better.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have good organ function based on lab tests.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of more than 3 months.
  • Have cancer that is getting worse despite standard treatments or for which no standard treatment exists.
  • Have a positive imaging scan showing uptake of the treatment in at least one known tumor.
  • Have a confirmed diagnosis of a solid tumor that is advanced or has spread to other parts of the body.

Exclusion Criteria

  • Have an allergy to the treatment or its ingredients.
  • Have another active cancer.
  • Be pregnant or breastfeeding.
  • Have cancer that has spread to the brain.
  • Have an active or uncontrolled infection requiring treatment in the last 3 days.
  • Have a medical condition that makes the study too risky.
  • Have issues that could interfere with the study or increase risk, such as inability to follow safety precautions.
  • Have a history of severe allergic reactions to the treatment.
  • Have had major surgery within the last 21 days and not fully recovered.
  • Have had a blood clot in the last 4 weeks.
  • Have a current substance abuse problem.
  • Have received a live vaccine in the last 7 days.
  • Have had any cancer treatment in the last 4 weeks.

Locations

FACILITYZIPCITYSTATE
Nebraska Cancer Specialists68130OmahaNebraska

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