Zanzalintinib for Liver Cancer

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests zanzalintinib, a medication that may stop liver cancer cells from growing by blocking a protein that signals them to multiply. The goal is to determine the safest and most effective dose for patients with advanced and metastatic liver cancer. The trial will also examine any side effects of the treatment. Individuals diagnosed with incurable liver cancer who have not found success with other treatments might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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, but it does mention that you cannot take certain medications like small-molecule kinase inhibitors or complementary medicines for the disease within a specific time before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

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

Research has shown that zanzalintinib might help treat advanced liver cancer. Earlier studies tested doses ranging from 10 to 140 mg, and the body handled the drug similarly across different patients. Although some individuals stopped treatment due to side effects, this occurrence was uncommon.

While specific side effects were not detailed, the drug's current phase 1 and 2 trials ensure careful monitoring for safety. These early phases aim to determine the right dose and identify any serious issues. If the drug passes these safety checks, it generally indicates that most patients can tolerate the side effects. Overall, zanzalintinib is being studied as a promising treatment for liver cancer, with ongoing research to fully understand its safety and effectiveness.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about zanzalintinib for liver cancer because it offers a novel approach compared to traditional treatments. Unlike standard therapies that often involve chemotherapy or targeted therapies like sorafenib, zanzalintinib is an experimental drug that may work through a unique mechanism of action, potentially targeting liver cancer cells differently. This could mean better outcomes for patients, especially if the drug can effectively slow down disease progression with fewer side effects. Additionally, the oral administration of zanzalintinib provides a more convenient option for patients, potentially enhancing their quality of life during treatment.

What evidence suggests that zanzalintinib might be an effective treatment for liver cancer?

Research has shown that zanzalintinib, a type of medication, may help treat advanced liver cancer by inhibiting proteins that promote tumor cell growth. In this trial, participants will receive zanzalintinib alone. Early results from other studies demonstrated that when combined with treatments like nivolumab, zanzalintinib helped shrink tumors in 63% of certain cancer cases, which is promising. In studies where zanzalintinib was used alone, it showed a 38% success rate in shrinking tumors and an 88% rate in stopping cancer growth, effectively controlling the disease in many patients. These findings suggest that zanzalintinib could be a helpful option for people with advanced liver cancer.12367

Who Is on the Research Team?

DM

Devalingam Mahalingam

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults with advanced liver cancer (hepatocellular carcinoma) that can't be cured by surgery or other treatments. They should have tried at least one treatment before, but not more than two, and can't have used cabozantinib. Their liver function must be fairly good (Child-Pugh class A or B7/B8), and they need to be physically well enough to do daily activities without much help (ECOG Status of 0-1).

Inclusion Criteria

I am 18 years old or older.
I've had up to two treatments for advanced cancer, not counting cabozantinib or palliative care.
My cancer can be measured by standard health tests.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zanzalintinib orally once daily on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Up to 1 year
Regular visits for ECHO/MUGA, urine and blood sample collection, and CT/MRI

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

1 year
Follow-up at 30 days post-treatment, then every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Zanzalintinib
Trial Overview The trial is testing Zanzalintinib's safety, side effects, best dose, and effectiveness in treating advanced liver cancer. It's a phase Ib/II study where Zanzalintinib—a tyrosine kinase inhibitor—is given to block proteins that cause tumor cells to grow.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (zanzalintinib)Experimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Zanzalintinib Plus Nivolumab Generates Early Antitumor ...Zanzalintinib plus nivolumab achieved a 63% ORR in ccRCC, outperforming the triplet with relatlimab, which had a 40% ORR. The doublet arm showed ...
Phase II trial of zanzalintinib (XL-092) in combination with ...A Phase II study (CHECKMATE 040) reported an impressive objective response rate (ORR) of 29% with the combination of ipilimumab/nivolumab and ...
Maintenance Zanzalintinib and Durvalumab in Participants ...The purpose of this study is to find out if taking zanzalintinib with durvalumab will improve how long people with advanced liver cancer will live. Detailed ...
Press Release - Exelixis, Inc.Results for Exelixis' next-generation tyrosine kinase inhibitor demonstrated an objective response rate of 38% and a disease control rate of 88% –.
Zanzalintinib in Second Line and Beyond for the Treatment ...Giving zanzalintinib may be safe, tolerable, and/or effective in treating patients with advanced liver cancer. SECONDARY OBJECTIVES: I.
Zanzalintinib Plus Atezolizumab Signals New Progress for ...Zanzalintinib plus atezolizumab significantly improved OS vs regorafenib, with a 20% reduction in the risk of death (HR, 0.80; 95% CI, 0.69-0.93 ...
Zanzalintinib (XL-092) Plus Durvalumab and ...Patients must have unresectable hepatocellular carcinoma. · Patients must be treatment naïve for systemic therapy in the unresectable setting. · ≥ ...
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