Zanzalintinib for Cancer

LS
Overseen ByLuana Sousa, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called zanzalintinib to determine its effectiveness in controlling recurrent or metastatic ONB cancer. The study also evaluates the treatment's safety for patients. Individuals with this specific cancer type, who have not received similar drugs and are unsuitable for surgery or radiotherapy, might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take certain medications like oral anticoagulants and some complementary medicines close to the start of the trial. 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 generally well-tolerated by patients. Previous studies found its safety comparable to other treatments that target multiple pathways to inhibit blood vessel growth in tumors. While some side effects may occur, they are usually manageable and expected with this type of treatment.

In one study, combining zanzalintinib with another drug significantly reduced the risk of death compared to another treatment, highlighting its effectiveness and tolerability. Another study suggested that zanzalintinib might be safer than similar treatments like cabozantinib, which the FDA has already approved for other uses. This suggests that zanzalintinib could be a safer option for some patients.

Overall, while every treatment carries potential risks, evidence so far indicates that zanzalintinib has an acceptable safety profile for patients with serious conditions. Patients should always consult their healthcare provider to understand what this means for their personal situation.12345

Why do researchers think this study treatment might be promising?

Zanzalintinib is unique because it targets cancer cells with a novel mechanism that isn't addressed by many standard treatments like chemotherapy or radiation. Unlike most traditional therapies that can affect both healthy and cancerous cells, Zanzalintinib is designed to specifically target and inhibit pathways critical for cancer cell survival, potentially leading to fewer side effects. Researchers are excited about Zanzalintinib because its oral administration makes it more convenient for patients, and its targeted approach offers promise for more effective and personalized cancer treatment options.

What evidence suggests that zanzalintinib might be an effective treatment for recurrent/metastatic ONB?

This trial will evaluate Zanzalintinib as a standalone cancer treatment. Research has shown that Zanzalintinib, when combined with other treatments like atezolizumab, yields promising results in cancer studies. One study demonstrated that this combination extended patient survival to an average of 10.9 months, compared to 9.4 months with regorafenib. It also reduced the risk of death by 20% in some cases. The treatment shrank tumors in 63% of patients and stabilized or improved the disease in 90% of cases. These findings suggest that Zanzalintinib could effectively treat recurring or spreading cancers.26789

Who Is on the Research Team?

LS

Luana Sousa, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for adults (18+) with recurrent or metastatic olfactory neuroblastoma who can't be cured by surgery or radiation. Participants must have good organ function, not be pregnant or breastfeeding, and haven't been treated before with VEGFR inhibitors like Zanzalintinib.

Inclusion Criteria

I am not pregnant right now.
I understand the study and have signed the consent form.
My blood, kidney, and liver tests show normal organ function.
See 6 more

Exclusion Criteria

I have not had radiation therapy for bone metastasis recently.
I do not have any serious or uncontrolled illnesses right now.
Subjects must not have known hypersensitivity to study drugs or related components
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Zanzalintinib at a dose of 60 mg orally once daily in a 28-day cycle

12 months
Monthly visits for each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Zanzalintinib

Trial Overview

The study is testing Zanzalintinib, a targeted cancer drug, to see if it can help control advanced olfactory neuroblastoma. Researchers will also monitor how safe the drug is for participants.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Phase 2: Treatment with ZanzalintinibExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Exelixis Announces Detailed Results from Phase 3 STELLAR ...

Zanzalintinib in combination with atezolizumab improved median overall survival to 10.9 months versus 9.4 months with regorafenib, and significantly reduced ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41130252/

Zanzalintinib plus atezolizumab versus regorafenib in ...

Grade 3 or worse treatment-related adverse events occurred in 268 (60%) of 446 patients receiving zanzalintinib-atezolizumab and 161 (37%) of ...

Zanzalintinib Plus Immune Checkpoint Inhibitor in ...

In a statement issued earlier this year,3 zanzalintinib demonstrated a 20% reduction in the risk of death, one of two study endpoints, with the ...

Results from an expansion cohort of the phase 1 STELLAR ...

In pts without LM, mOS was not reached and 12.5 months (HR 0.46, 0.15–1.36) with 6-month survival rates of 88% and 65%, confirmed ORR was 18.0% ...

Articles Zanzalintinib plus atezolizumab versus regorafenib ...

Introduction. Outcomes for metastatic colorectal cancer remain poor, with a 5-year relative survival rate of approximately 15%.1 Immune ...

STELLAR-303: randomized phase III study of zanzalintinib + ...

In this heavily pretreated patient population, zanzalintinib demonstrated an ORR of 10 and 4% for single-agent and combination therapy, respectively, and ...

Zanzalintinib as Cabozantinib's Successor: The Case for ...

It is possible that zanzalintinib (100 mg once daily) offers a safety advantage over cabozantinib administered at the FDA-labeled monotherapy ...

Exelixis Announces Zanzalintinib in Combination with an ...

Zanzalintinib in combination with atezolizumab demonstrated a statistically significant reduction in risk of death versus regorafenib in ...

Zanzalintinib in MSS Metastatic Colorectal Cancer

Safety and Tolerability. The safety profile of zanzalintinib reflects the expected pattern of multi-target anti-angiogenic therapies, with ...