Zanzalintinib + MO-03 for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a new combination of treatments, zanzalintinib and MO-03, can address kidney cancer that has spread and worsened despite previous immunotherapy. Zanzalintinib blocks enzymes that aid cancer cell growth, while MO-03 enhances zanzalintinib's effectiveness by altering gut bacteria. The trial seeks participants with renal cell carcinoma that has progressed after treatments, including immunotherapy and cabozantinib, and who can provide tumor biopsy samples. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you must stop any complementary medications like herbal supplements two weeks before starting the trial. If you're on certain anticoagulants, you may need to switch or stop them before the trial, so it's best to discuss this with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that zanzalintinib offers promising results for treating advanced kidney cancer. Patients have experienced good antitumor activity, indicating the drug can shrink or control tumors. Importantly, the treatment is mostly well-tolerated, with manageable side effects.
Zanzalintinib has been tested with other drugs, such as nivolumab, and has demonstrated both safety and effectiveness. For instance, one study found that zanzalintinib combined with atezolizumab reduced the risk of death by 20% compared to other treatments, suggesting the drug's relative safety.
MO-03, a drug that helps control gut bacteria, is expected to work well with zanzalintinib, potentially enhancing the cancer treatment's effectiveness. However, specific safety data for MO-03 alone is not highlighted here.
Overall, previous research supports that the combination of zanzalintinib and MO-03 is generally safe for patients with advanced kidney cancer, with manageable side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Zanzalintinib for kidney cancer because it introduces a novel mechanism of action compared to standard treatments like sunitinib and pazopanib. Unlike these existing therapies, which mainly target the vascular endothelial growth factor (VEGF) pathway, Zanzalintinib offers a broader approach by also inhibiting additional pathways that may contribute to tumor growth and spread. This comprehensive targeting could potentially improve treatment outcomes and provide benefits to patients who have limited options with current therapies.
What evidence suggests that zanzalintinib and MO-03 might be effective for metastatic renal cell cancer?
This trial will evaluate the combination of zanzalintinib and MO-03 for kidney cancer. Studies have shown that zanzalintinib, when combined with another drug like nivolumab, has a strong effect on kidney cancer. In one study, 63% of patients responded positively, and their cancer progression halted for about 18.5 months. This is promising because zanzalintinib targets key enzymes that cancer cells need to grow. Adding MO-03, which influences gut bacteria, could enhance this effect. Early research suggests that zanzalintinib with MO-03 might be effective for kidney cancer that has spread and worsened after other treatments.13678
Who Is on the Research Team?
Sumanta K Pal
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with kidney cancer that has spread to other parts of the body and has gotten worse after previous immunotherapy treatment. Participants should be able to take oral medications and have no major health issues that would prevent them from joining.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive XL092 orally once daily and MO-03 twice daily on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and every 12 weeks for 2 years.
What Are the Treatments Tested in This Trial?
Interventions
- MO-03
- Zanzalintinib
Trial Overview
The study is testing a combination of two treatments: zanzalintinib (a targeted therapy) and MO-03 (a probiotic capsule), to see if they work together to treat advanced kidney cancer after immunotherapy has stopped working.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive XL092 PO QD and MO-03 PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Study treatment may continue after progression if the Investigator believes that the subject is still receiving clinical benefit. Patients undergo CT scan, bone scan, and blood and urine sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Zanzalintinib and MO-03 for the Treatment of Metastatic ...
Giving zanzalintinib with MO-03 may be effective for treating metastatic renal cell cancer after progression on immunotherapy. Detailed ...
Zanzalintinib Combinations for Renal Cell Carcinoma
Research has shown that combining zanzalintinib and AB521 may help treat advanced kidney cancer, known as renal cell carcinoma (RCC). ... efficacy data from this ...
3.
urologytimes.com
urologytimes.com/view/zanzalintinib-plus-nivolumab-shows-safety-efficacy-for-stage-4-rccZanzalintinib plus nivolumab shows safety, efficacy for ...
Zanzalintinib and nivolumab showed a 63% response rate and 18.5-month median PFS in stage 4 RCC. · The study included patients with advanced RCC, ...
4.
onclive.com
onclive.com/view/dr-runcie-on-treatment-approaches-in-rcc-after-progression-on-adjuvant-therapyDr Runcie on Treatment Approaches in RCC After ...
The ongoing phase 2 EXACT trial (NCT06863311) is further investigating zanzalintinib in combination with immunotherapy for patients with RCC who ...
5.
cancertherapyadvisor.com
cancertherapyadvisor.com/cch/advanced-renal-cell-carcinoma-ikcs-2025-cabozantinib-axitinib/Advanced Renal Cell Carcinoma: Treatment Insights From ...
Key efficacy results included a 6-month progression-free rate in brain metastases of 56% and a brain metastases response rate of 61.5%. These findings highlight ...
Combination drug regimens for metastatic clear cell renal cell ...
The N3l1 and N1l3 combination groups had similarly efficacious results (2-year OS was 67.3% and 69.6% respectively) but the N3l1 group had significantly less ...
7.
targetedonc.com
targetedonc.com/view/novel-tki-zanzalintinib-confers-promising-antitumor-activity-in-advanced-ccrccNovel TKI Zanzalintinib Confers Promising Antitumor ...
Patients with advanced clear cell renal cell carcinoma treated with zanzalintinib had experienced promising antitumor activity with manageable toxicity.
Zanzalintinib and MO-03 for the Treatment of Metastatic ...
This phase II trial tests how well zanzalintinib and MO-03 works for the treatment of renal cell cancer that has spread from where it first started (primary ...
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