Study on Patritumab Deruxtecan for Patients with Brain Tumors

Sponsor: Mustafa Khasraw, MBChB, MD, FRCP, FRACP

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05620914

Provider View

This clinical trial is exploring whether the drug patritumab deruxtecan can be detected in brain tumor tissue after a single dose is given before surgery. The study aims to understand how the drug behaves in the body and its effects on the immune system.

Patient Parameters

Program Overview

The study is designed to see if patritumab deruxtecan, a drug being tested, can be found in brain tumor tissue after patients receive one dose before their surgery. Researchers will look at how the drug moves through the body, its effects on the immune system around the tumor, and any side effects. Patients will receive the drug through an IV before surgery and will undergo various tests, including blood draws, MRI scans, and other procedures. The study will last about 40 days, and potential side effects include nausea, fatigue, and low blood counts.

Description

This study involves giving patients with brain metastases a single dose of patritumab deruxtecan before they undergo surgery to remove the tumor. The goal is to measure how much of the drug reaches the brain tumor and to study its effects on the immune system and any side effects. Participants will have a series of tests, including blood tests, MRI scans, and possibly a lumbar puncture, to monitor their health and the drug's impact. The study will last approximately 40 days, and participants will be closely monitored for any side effects, which may include diarrhea, nausea, fatigue, and low blood counts. All participants will be included in the analysis of any adverse events that occur during the study.

Eligibility Criteria

Inclusion Criteria

  • Have newly diagnosed or returning brain metastases, with at least one tumor that can be surgically removed.
  • The original cancer must be one of the following types: melanoma, stomach cancer, breast cancer, colorectal cancer, bladder cancer, ovarian cancer, bile duct cancer, prostate cancer, or lung cancer.
  • Be either symptom-free or have well-controlled symptoms from the brain metastasis.
  • Be willing and able to undergo brain surgery.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 7 months after.
  • Men must agree to use effective birth control during the study and for 4 months after.
  • Be 18 years or older.
  • Have a performance status score of 70 or higher, indicating the ability to care for oneself.
  • Have adequate blood cell counts and organ function based on recent lab tests.
  • Be able to understand and sign an informed consent form.
  • Be able to undergo an MRI scan.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have a life-threatening brain condition as assessed by a doctor.
  • Have severe active health issues, such as infections or heart disease.
  • Have had another cancer within the past year, except for certain non-threatening types.
  • Have a known allergy to patritumab deruxtecan or its components.
  • Have been treated with patritumab deruxtecan before.
  • Have active autoimmune diseases requiring treatment.
  • Have lung diseases or conditions affecting the lungs.
  • Have had a complete lung removal surgery.
  • Are taking high doses of steroids or immunosuppressive drugs.
  • Have leptomeningeal disease (cancer spread to the membranes around the brain and spinal cord).
  • Have significant eye disease.
  • Have unresolved side effects from previous cancer treatments.
  • Have uncontrolled heart disease or high blood pressure.
  • Have active hepatitis B or C infections.
  • Have HIV infection.
  • Have any other serious health conditions that could interfere with the study.

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