Zanzalintinib for Brain Tumor

Not yet recruiting at 2 trial locations

Overseen By Exelixis Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Exelixis

Must not be taking: Cytotoxic, Biologic, Anticancer, Investigational

Disqualifiers: Hypertensive encephalopathy, Uncontrolled hypertension, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests zanzalintinib, a new treatment for brain tumor patients with meningioma that has returned or continued to grow despite standard treatments like surgery or radiation. The main goal is to evaluate the effectiveness and safety of zanzalintinib for individuals with this condition. Participants must have a confirmed diagnosis of meningioma and have experienced tumor growth or new tumor spots after previous treatments. Those who have undergone at least one round of radiation and still face tumor progression may find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received any type of systemic anticancer therapy within 4 weeks before starting the trial treatment.

Is there any evidence suggesting that zanzalintinib is likely to be safe for humans?

Research has shown that zanzalintinib is generally safe for humans. Studies have found that, whether used alone or with other drugs, it does not raise major safety concerns. For example, a study testing zanzalintinib with an anti-PDL1 therapy found it safe without causing significant side effects.

In other studies involving different types of cancer, combining zanzalintinib with treatments like pembrolizumab also demonstrated a manageable safety profile. Although some reports do not detail specific side effects, these findings suggest a consistent pattern of safety for zanzalintinib in various uses.

Overall, while no treatment is completely without risk, current evidence suggests that zanzalintinib could be a safe option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Zanzalintinib is unique because it represents a novel approach to treating brain tumors. Unlike many current treatments, which often involve surgery, radiation, or chemotherapy to kill cancer cells, Zanzalintinib targets specific pathways within tumor cells, potentially minimizing damage to healthy brain tissue. Researchers are excited about this treatment because it could offer a more targeted and less invasive option, which might lead to fewer side effects and improved quality of life for patients.

What evidence suggests that zanzalintinib might be an effective treatment for brain tumors?

Research has shown that zanzalintinib, when combined with other drugs like nivolumab, yields promising results in treating various cancers. In one study, 63% of patients experienced tumor shrinkage, and 90% had their disease under control. Although these results come from different types of cancer, they suggest that zanzalintinib could be effective against difficult-to-treat tumors. This trial will evaluate zanzalintinib as a standalone treatment for brain tumors. The treatment targets specific proteins that aid tumor growth, potentially combating cancers that have not responded well to standard treatments. ^{2 3 6 7 8}

Who Is on the Research Team?

Study Director

Principal Investigator

Exelixis

Are You a Good Fit for This Trial?

This trial is for people with meningioma (a type of brain tumor) that has come back or gotten worse after standard treatments like surgery or radiation. Participants must have a certain level of daily functioning, measurable disease, and healthy major organs.

Inclusion Criteria

My tumor has grown or new tumors have appeared in the last 6 months.

I have a tumor that can be measured by recent scans.

I meet the main requirements for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zanzalintinib once daily for the duration of the study

12 weeks

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 the safety and effectiveness of zanzalintinib in patients with recurrent or progressive meningioma who haven't responded to usual therapies. All participants receive zanzalintinib.

How Is the Trial Designed?

Group I: Zanzalintinib Experimental Treatment 1 Intervention

Participants will receive zanzalintinib once daily (QD).

Who Is Running the Clinical Trial?

Exelixis

Lead Sponsor

Trials

126

Recruited

20,500+

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

Citations

1.

targetedonc.com

targetedonc.com/view/zanzalintinib-atezolizumab-improves-crc-survival-expands-tki-s-role-in-solid-tumors

Zanzalintinib/Atezolizumab Improves CRC Survival ...

Zanzalintinib combined with atezolizumab significantly improved overall survival in metastatic colorectal cancer patients compared to ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11916370/

STELLAR-304: a phase III study of zanzalintinib (XL092) plus ...

In a phase Ib study in advanced solid tumors, cabozantinib plus atezolizumab (a PD-L1 inhibitor) led to an ORR of 31% (80% CI: 20–44) and median PFS of 9.5 (95% ...

3.

ir.exelixis.com

ir.exelixis.com/news-releases/news-release-details/exelixis-announces-encouraging-results-phase-1b2-stellar-002

Press Release - Exelixis, Inc.

Zanzalintinib in combination with nivolumab demonstrated an objective response rate of 63% and a disease control rate of 90%.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05176483

NCT05176483 | Study of Zanzalintinib in Combination With ...

In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion ...

5.

withpower.com

withpower.com/trial/phase-2-and-3-neoplasms-6-2025-e4eca

Zanzalintinib for Neuroendocrine Tumors

One study found that when combined with nivolumab, 63% of patients experienced tumor shrinkage. Additionally, 90% of participants either saw their tumors shrink ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12057161/

STELLAR-305: phase II/III study of zanzalintinib plus ... - PMC

In vitro, zanzalintinib demonstrated potent inhibition of VEGFR2, MET, AXL, and MER kinases, and a decrease in tumor cell proliferation.

7.

onclive.com

onclive.com/view/zanzalintinib-plus-atezolizumab-boosts-os-in-previously-treated-non-msi-h-mcrc

Zanzalintinib Plus Atezolizumab Boosts OS in Previously ...

Zanzalintinib plus atezolizumab improved overall survival in previously treated, non–MSI-H metastatic colorectal cancer.

8.

withpower.com

withpower.com/trial/phase-2-and-3-carcinoma-10-2023-072d5

Zanzalintinib + Pembrolizumab for Head and Neck Cancer

The treatment showed clinically meaningful antitumor activity, with an overall response rate of 18%, and particularly higher in HPV-positive patients at 25%, ...