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N-(4-Fluorophenyl)-N-(4-((7-Methoxy-6-(Methylcarbamoyl)Quinolin-4- Yl)Oxy)Phenyl)Cyclopropane-1,1-Dicarboxamide

This article summarizes several clinical trials investigating the use of N-(4-Fluorophenyl)-N-(4-((7-Methoxy-6-(Methylcarbamoyl)Quinolin-4-Yl)Oxy)Phenyl)Cyclopropane-1,1-Dicarboxamide, also known as XL092 or zanzalintinib, in patients with various advanced cancers. XL092 is being studied alone and in combination with other cancer drugs for conditions like renal cell carcinoma, colorectal cancer, head and neck cancer, and other solid tumors. The trials aim to determine the safety, effectiveness, and optimal dosing of XL092 in treating these difficult-to-treat cancers.

Table of Contents

What is XL092?

XL092, also known as zanzalintinib, is a new investigational drug being developed for the treatment of various advanced cancers[1]. It is a type of medication called a multi-targeted inhibitor of receptor tyrosine kinases. This means it works by blocking several proteins that are important for cancer growth and spread[2].

How does XL092 work?

XL092 is designed to target multiple proteins involved in cancer growth and progression. By inhibiting these proteins, it may help to slow down or stop the growth of cancer cells. The drug is being studied both alone and in combination with other cancer treatments, particularly immunotherapy drugs like nivolumab, ipilimumab, relatlimab, and atezolizumab[3]. These combinations aim to enhance the body’s immune response against cancer while also directly targeting cancer cells.

What types of cancer is XL092 being studied for?

XL092 is being investigated for several types of advanced or metastatic cancers, including:

  • Renal cell carcinoma (kidney cancer), both clear cell and non-clear cell types[1]
  • Metastatic castration-resistant prostate cancer[3]
  • Urothelial carcinoma (bladder cancer)[3]
  • Colorectal cancer[3][4]
  • Hepatocellular carcinoma (liver cancer)[3]
  • Non-small cell lung cancer[3]
  • Head and neck squamous cell carcinoma[2][3]

How is XL092 administered?

XL092 is taken orally as a tablet, typically once daily[1][2][3][4]. The exact dosage may vary depending on the specific clinical trial and the type of cancer being treated. In some studies, the maximum daily dose being tested is 100-120 mg[1][2][4].

What are the potential side effects of XL092?

As XL092 is still in clinical trials, the full range of potential side effects is not yet known. However, some general considerations for patients participating in these trials include:

  • Patients must have adequate organ and bone marrow function to participate in the trials[1][2][3][4].
  • Patients with certain heart conditions, including a history of prolonged QT interval (a measure of heart rhythm), may be excluded from the trials[1][2][3][4].
  • As with many cancer treatments, there may be risks related to fertility and pregnancy. Patients of childbearing potential must use effective contraception during the trials and for a period after treatment[1][2][3][4].

The clinical trials are closely monitoring for any adverse events (side effects) to better understand the safety profile of XL092.

Ongoing Clinical Trials

Several clinical trials are currently underway to evaluate the safety and effectiveness of XL092:

  • A Phase 3 study comparing XL092 plus nivolumab to sunitinib for advanced non-clear cell renal cell carcinoma[1].
  • A Phase 2/3 study of XL092 plus pembrolizumab for recurrent or metastatic head and neck squamous cell carcinoma[2].
  • A Phase 1b study evaluating XL092 alone and in combination with various immunotherapy drugs for multiple types of advanced solid tumors[3].
  • A Phase 3 study comparing XL092 plus atezolizumab to regorafenib for metastatic colorectal cancer[4].

These trials are assessing various outcomes, including how well the drug works (efficacy), its safety profile, and how patients’ bodies process the drug (pharmacokinetics).

Conclusion

XL092 (zanzalintinib) is a promising new drug being studied for multiple types of advanced cancers. Its unique mechanism of action, targeting multiple proteins involved in cancer growth, makes it an interesting candidate for cancer treatment. The ongoing clinical trials will provide crucial information about its effectiveness and safety. Patients interested in learning more about XL092 or potentially participating in clinical trials should discuss this with their oncologist.

Trial Name Cancer Type Treatment Phase Primary Endpoints
STELLAR-303 Metastatic Colorectal Cancer XL092 + Atezolizumab vs Regorafenib 3 Overall Survival
2023-506308-24-00 Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma XL092 + Pembrolizumab vs Pembrolizumab alone 2/3 Progression-free Survival, Overall Survival
2023-510061-10-00 Advanced Solid Tumors XL092 alone and with Nivolumab, Ipilimumab, or Relatlimab 1b Safety, Tolerability, Recommended Dose
2022-501703-27-00 Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma XL092 + Nivolumab vs Sunitinib 3 Progression-free Survival, Objective Response Rate

FAQ

  • What is XL092? XL092, also called zanzalintinib, is an experimental cancer drug that targets multiple proteins involved in cancer growth. It's being tested to treat various advanced cancers, often in combination with other medications.
  • What types of cancer is XL092 being studied for? XL092 is being investigated for several types of advanced cancers, including renal cell carcinoma (kidney cancer), colorectal cancer, head and neck cancer, and other solid tumors that have spread or cannot be removed surgically.
  • How is XL092 given to patients? XL092 is taken orally as a tablet, usually once daily. The exact dose may vary depending on the specific trial and combination of drugs being tested.
  • What are some of the other drugs XL092 is being combined with? In these trials, XL092 is being studied in combination with drugs like nivolumab, ipilimumab, relatlimab, atezolizumab, and pembrolizumab. These are types of immunotherapy drugs that help the immune system fight cancer.
  • What are the main goals of these clinical trials? The main goals are to determine if XL092 is safe and effective for treating various advanced cancers, find the best dose to use, understand how it interacts with other cancer drugs, and measure how well it works in shrinking tumors or helping patients live longer.

Ongoing Clinical Trials on N-(4-Fluorophenyl)-N-(4-((7-Methoxy-6-(Methylcarbamoyl)Quinolin-4- Yl)Oxy)Phenyl)Cyclopropane-1,1-Dicarboxamide

  • Belzutifan and Zanzalintinib in Adults with Advanced Renal Cell Carcinoma After PD-1/L1 and VEGF-TKI Therapy

    Recruiting

    3 1 1
    Investigated drugs:
    Czechia Denmark France Germany Greece Italy +3

  • A Study of Belzutifan and Zanzalintinib Compared to Cabozantinib in Patients with Advanced Kidney Cancer that Returned After Previous Treatment

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Croatia Czechia Denmark France +6

  • A study comparing XL092 versus everolimus in patients with previously treated advanced or metastatic neuroendocrine tumors

    Recruiting

    4 1 1 1
    Investigated drugs:
    Austria Belgium France Germany Italy The Netherlands +2

  • Study of XL092 and belzutifan combination therapy in people with clear cell kidney cancer who had disease return during or after immunotherapy treatment

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Poland Spain

  • Study comparing XL092 plus nivolumab versus sunitinib for patients with advanced or metastatic non-clear cell kidney cancer

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    Bulgaria Croatia Czechia Denmark Finland France +8

  • Efficacy Comparison of Zanzalintinib (XL092) and Pembrolizumab Versus Pembrolizumab Monotherapy in PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    Not recruiting

    4 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia France Germany +7

  • Study Comparing XL092 and Atezolizumab with Regorafenib for Patients with Metastatic Colorectal Cancer

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Belgium France Germany Hungary Poland Portugal +1

  • Study on the Safety and Effects of XL092 with Nivolumab, Ipilimumab, and Relatlimab for Patients with Advanced Solid Tumors

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium France Germany Italy Poland +1

Glossary

  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Renal Cell Carcinoma (RCC): The most common type of kidney cancer in adults.
  • Colorectal Cancer: Cancer that starts in the colon or rectum.
  • Immunotherapy: A type of cancer treatment that helps the body's immune system fight cancer.
  • Solid Tumor: An abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign or malignant.
  • Progression-free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Overall Survival (OS): The length of time from either the date of diagnosis or the start of treatment that patients are still alive.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it is absorbed, distributed, metabolized, and excreted.
  • Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.
  • RECIST: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer patient responds to treatment.

References

  1. http://clinicaltrials.eu/trial/study-comparing-xl092-and-nivolumab-with-sunitinib-for-patients-with-advanced-or-metastatic-non-clear-cell-kidney-cancer/
  2. http://clinicaltrials.eu/trial/study-of-xl092-and-pembrolizumab-for-patients-with-pd-l1-positive-recurrent-or-metastatic-head-and-neck-cancer/
  3. http://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-xl092-with-nivolumab-ipilimumab-and-relatlimab-for-patients-with-advanced-solid-tumors/
  4. http://clinicaltrials.eu/trial/study-comparing-xl092-and-atezolizumab-with-regorafenib-for-patients-with-metastatic-colorectal-cancer/