XL092 for Thyroid Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Must not be taking: Anticoagulants, CYP inhibitors, CYP inducers, others

Disqualifiers: Hepatitis B, Hepatitis C, Pregnancy, 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: 3

Duration: 12 months

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, XL092, to evaluate its effectiveness for individuals with a type of thyroid cancer that hasn't responded to certain previous treatments and has spread locally or to other parts of the body. XL092 aims to stop cancer cells from growing by blocking signals that prompt them to multiply. The trial may suit those whose thyroid cancer is unresponsive to radioiodine treatment and has spread, and for whom other treatments have failed. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are taking certain anti-retroviral drugs or oral anticoagulants, you may need to change or stop them before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that XL092 is likely to be safe for humans?

Research shows that XL092 is generally safe for people. Studies have found that side effects are mostly mild to moderate, meaning some people might feel uncomfortable, but it's usually not serious. In earlier studies, XL092, both alone and with another drug, proved safe for patients who had already tried several treatments. Importantly, one study confirmed that XL092 was well-tolerated without major safety concerns. This suggests that many people can take XL092 without serious problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for thyroid cancer, which often include surgery, radioactive iodine, and traditional chemotherapy, XL092 offers a new approach by targeting specific cancer pathways. XL092 is a small molecule inhibitor that acts on multiple tyrosine kinases, which are enzymes involved in the growth and spread of cancer cells. This mechanism could potentially lead to more effective control of the disease with fewer side effects. Researchers are excited about XL092 because it could provide a more targeted treatment option, reducing the impact on healthy cells and improving patients' quality of life.

What evidence suggests that XL092 might be an effective treatment for thyroid cancer?

Research has shown that XL092 holds promise for treating a type of thyroid cancer unresponsive to standard radioiodine treatment. XL092 is a tyrosine kinase inhibitor, which blocks certain proteins that aid cancer cell growth. In earlier studies, XL092, both alone and with another drug called atezolizumab, produced positive results in patients who had tried other treatments. This trial will focus on XL092 alone, suggesting it might help slow or stop the growth of thyroid cancer cells. Although more research is needed, these early findings offer hope for patients with this type of cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Jochen H Lorch

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for patients with differentiated thyroid cancer that hasn't responded to radioiodine treatment and has spread locally or elsewhere in the body. Participants should have a history of disease progression despite prior therapies.

Inclusion Criteria

Patients must have measurable disease according to RECIST v 1.1

My thyroid cancer is advanced, doesn't respond to iodine treatment, and has worsened in the last year.

ALP (alkaline phosphatase) ≤ 3 x Institutional ULN; For subjects with documented bone metastasis, ≤ 5 x ULN

Exclusion Criteria

I have not had significant blood in my urine, vomit, or coughed up blood in the last 3 months.

I have symptoms from lung cavities or airway disease.

I have hepatitis B.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive XL092 orally daily on days 1-21 of each cycle, with cycles repeating every 21 days in the absence of disease progression or unacceptable toxicity

12 months

Regular visits for imaging and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days then every 3 months for 12 months

12 months

Follow-up visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• XL092

Trial Overview

The study tests XL092, a tyrosine kinase inhibitor designed to block proteins that signal cancer cells to grow. It's given to see if it can stop the growth of thyroid cancer cells in patients with advanced stages of the disease.

How Is the Trial Designed?

Group I: Treatment (XL092) Experimental Treatment 6 Interventions

Patients receive XL092 PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and x-ray imaging, and blood and urine sample collection throughout the study.

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

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06959641

XL092 for the Treatment of Locally Advanced or Metastatic ...

This phase II trial tests how well XL092 works for the treatment of patients with differentiated thyroid cancer that has not responded to previous treatment ...

2.

cancer.northwestern.edu

cancer.northwestern.edu/clinical-trials/trials.html?code[]=thyroid_cancer&cancerType=Thyroid+Cancer

Search Thyroid Cancer Trials

This study assesses efficacy of treatment with XL092 (Zanzalintinib) in radioactive iodine refractory Differentiated Thyroid Cancer patients by evaluating ...

3.

ir.exelixis.com

ir.exelixis.com/news-releases/news-release-details/exelixis-announces-dose-escalation-results-phase-1-stellar-001

Exelixis Announces Dose-Escalation Results from the Phase ...

Both single-agent XL092 and XL092 in combination with atezolizumab demonstrated encouraging efficacy and safety in a heavily pretreated patient population.

4.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-01421

XL092 and Cemiplimab for the Treatment of BRAF V600E- ...

Giving XL092 and cemiplimab before and after surgery may be safe, tolerable and/or effective in treating patients with BRAF V600E wild type anaplastic thyroid ...

5.

withpower.com

withpower.com/trial/phase-2-adenocarcinoma-8-2026-7beba

XL092 for Thyroid Cancer

This phase II trial tests how well XL092 works for the treatment of patients with differentiated thyroid cancer that has not responded to previous treatment ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06959641

XL092 for the Treatment of Locally Advanced or Metastatic ...

This phase II trial tests how well XL092 works for the treatment of patients with differentiated thyroid cancer that has not responded to previous treatment ...

7.

tandfonline.com

tandfonline.com/doi/abs/10.1080/13543784.2024.2388571

Zanzalintinib (XL092): a next-generation tyrosine kinase ...

Furthermore, a recent phase 1 dose escalation study confirmed the tolerability of the zanzalintinib and anti-PDL1 combination without major safety concerns.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9890135/

Preclinical Characterization of XL092, a Novel Receptor ...

In summary, XL092 was shown to have significant antitumor and immunomodulatory activity in animal models both alone and in combination with immune checkpoint ...