A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors
Study of XL092 Alone or in Combination with Anticancer Therapy in Patients with Unresectable orMetastatic Solid Tumors
Sponsor: Exelixis
Enrolling: Male and Female Patients
IRB Number: AAAU5737
U.S. Govt. ID: NCT05176483
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to evaluate the efficacy of the study drug, XL092 alone and/or in combination of other study drugs such as with nivolumab, nivolumab plus ipilimumab, or nivolumab/relatlimab fixed-dose combination as a potential anticancer therapy to treat people with locally advanced or metastatic cancers including advanced renal cell cancer, castration-resistant prostate cancer, bladder cancer, liver cancer, lung cancer, colon cancer, head and neck cancer. Nivolumab has been approved as single agent for the treatment of melanoma, lung cancer, and bladder cancer and in combination with a drug similar to XL092 for the treatment of kidney cancer by the United States Food and Drug Administration (FDA). The combination of drugs, Nivolumab and ipilimumab, was also approved as a combination therapy by the FDA for the treatment of certain types of kidney cancer, colon cancer (colorectal cancer), skin cancer (melanoma), and lung cancer (non-small cell lung cancer) that have spread to other areas of the body. Nivolumab with relatlimab has been FDA-approved for the treatment of melanoma that has spread to other areas of the body. However, XL092 alone and/or in these combinations of other study drugs are not approved by the FDA and are all considered study drugs because their combination as an anti-cancer therapy has not been approved. This study will provide information about the safety, the ability of the body to accept the study drug(s), the amount of study drug(s) and/or break-down products in the blood, and body's reaction to the study drug(s). We want to see if XL092 alone and in combination with the other study drugs induces an immune response and if it has an effect on prostate cancer. XL092 is considered immunotherapeutic study drug, which means that it is meant to work by stimulating a person's immune system to react and help fight against the studied cancers.
Karie D. Runcie, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Do you have a solid tumor that is unresectable (unable to be removed with surgery) or metastatic (cancer spread to second site)? Yes No
Are you able to swallow the study drug? Yes No
You may be eligible for this study

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