Study on Zanzalintinib for Advanced Kidney Cancer with Bone Spread

Sponsor: Kelly Fitzgerald, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07043608

Provider View

This clinical trial is testing a new treatment, zanzalintinib, combined with a bone-strengthening agent, for patients with advanced kidney cancer that has spread to the bones. The study aims to see if this combination can help control the cancer in patients who have already tried other treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of zanzalintinib, a new drug, in combination with a bone-strengthening agent, for patients with advanced kidney cancer that has spread to the bones. The study will focus on patients whose cancer has progressed despite previous treatments, including at least one immune-based therapy. Participants will receive zanzalintinib and a bone-strengthening agent, and their progress will be monitored to see if the treatment helps control the cancer and improve their quality of life.

Description

The main goal of this study is to see if the combination of zanzalintinib and a bone-strengthening agent can help keep the cancer from getting worse for at least 12 months in patients with advanced kidney cancer that has spread to the bones. Researchers will also look at how often patients experience bone-related issues, jaw problems, and other side effects. They will measure how long patients live without the cancer getting worse and overall survival rates. Additionally, the study will explore how the treatment affects the bone environment and patients' quality of life.

Participants will receive zanzalintinib and a bone-strengthening agent. Radiation therapy for bone pain is allowed if needed. The treatment will continue until the cancer progresses, side effects become unacceptable, or the patient decides to stop. Patients will be followed for up to 24 months to monitor their survival and health outcomes.

Eligibility Criteria

Inclusion Criteria

  • Have advanced kidney cancer that cannot be surgically removed and has spread to the bones.
  • Have at least three bone metastases, with at least one not planned for radiation treatment.
  • Previously treated with 1-3 lines of therapy, including immune-based treatments.
  • Be 18 years or older.
  • Have seen a dentist within 90 days before joining the study and cleared for bone-strengthening treatment.
  • Provide a tumor sample for diagnosis.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have adequate organ function based on specific blood tests.
  • Have recovered from any side effects of previous treatments.
  • Be able to understand and sign a consent form.
  • HIV-positive individuals on effective treatment with undetectable viral load are eligible.
  • Hepatitis B and C infections must be under control or treated.
  • Agree to use effective contraception during and after the study.

Exclusion Criteria

  • Previous treatment with zanzalintinib for kidney cancer.
  • Recent treatment with certain cancer drugs or participation in another drug study.
  • Untreated or unstable brain metastases.
  • Need for whole brain radiation therapy.
  • Incomplete healing from previous radiation.
  • Severe allergic reactions to similar treatments.
  • Pregnant or breastfeeding women.
  • Recent significant vascular disease or bleeding issues.
  • Gastrointestinal problems that require special feeding or hydration.
  • Use of certain anticoagulants or complementary medicines.
  • Uncontrolled heart, lung, or other serious health conditions.
  • Recent major surgery or inability to swallow tablets.
  • Other conditions that may affect safety or study completion.

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