Zanzalintinib for Kidney Cancer with Bone Metastases
(ZAMBONI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of zanzalintinib for treating kidney cancer that has spread to the bones. Researchers aim to determine if this drug, combined with a bone-strengthening agent, can benefit patients whose cancer has progressed after trying other treatments, including at least one type of immune therapy. Suitable candidates have advanced kidney cancer with at least three bone metastases and have previously tried 1-3 other therapies. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering a chance to contribute to important advancements in cancer care.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but it does mention that certain medications, like small molecule kinase inhibitors and some anticoagulants, should be stopped before starting the study treatment. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that zanzalintinib is likely to be safe for humans?
Research has shown that zanzalintinib is promising in terms of safety for patients with advanced kidney cancer. Patients have tolerated zanzalintinib well in studies, whether used alone or with other treatments like nivolumab. Specifically, the STELLAR-002 study found that the combination had manageable safety for those with untreated stage 4 kidney cancer, meaning side effects were not severe enough to outweigh the treatment's benefits.
Additionally, when used alone, zanzalintinib has shown promising results in shrinking tumors in patients who have already tried other treatments for clear cell kidney cancer. While specific side effects weren't detailed, "manageable safety" suggests that any side effects are generally not life-threatening or too difficult to handle.
This trial is in the second phase, indicating that zanzalintinib has already been tested for safety in humans. This offers some reassurance about its safety, but ongoing trials are still needed to confirm these findings.12345Why do researchers think this study treatment might be promising?
Zanzalintinib is unique because it specifically targets kidney cancer with bone metastases, offering a novel approach compared to traditional treatments like tyrosine kinase inhibitors or immune checkpoint inhibitors. Unlike these standard options, Zanzalintinib is administered orally, providing a more convenient mode of delivery. Researchers are particularly excited about its potential to work alongside bone-strengthening agents, addressing both the cancer and its impact on the bones simultaneously. This dual approach could enhance patient quality of life by managing symptoms effectively while targeting the cancer itself.
What evidence suggests that zanzalintinib might be an effective treatment for kidney cancer with bone metastases?
Studies have shown that zanzalintinib, the investigational drug tested in this trial for kidney cancer with bone metastases, has promising results. In one study, 38% of patients experienced a reduction in cancer size, and 88% saw their cancer either shrink or stop growing. Although this trial focuses on zanzalintinib alone, previous research indicates that combining zanzalintinib with nivolumab increased the number of patients who saw their cancer shrink to 63%, with 90% experiencing either shrinkage or stability. These findings suggest that zanzalintinib effectively manages advanced kidney cancer, even when other treatments have failed.16789
Who Is on the Research Team?
Kelly Fitzgerald, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for patients with advanced kidney cancer that has spread to the bones. They must have tried 1-3 previous treatments, including at least one immune-based therapy. It's not suitable for those who haven't had prior treatment or don't meet specific health requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 100 mg Zanzalintinib orally once a day in 28-day cycles, along with an investigator-choice bone-strengthening agent. Radiation therapy for symptomatic metastases is allowed.
Follow-up
Participants are monitored for safety, effectiveness, and survival after treatment, with assessments for progression-free survival and overall survival.
What Are the Treatments Tested in This Trial?
Interventions
- Zanzalintinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kelly Fitzgerald, MD
Lead Sponsor
Exelixis
Industry Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD