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


NCT Number:



Study Status:






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.

Are you Eligible? (Inclusion Criteria)

  • 18 years old or older - Able to swallow study drug - Confirmed to have solid tumor that is unresectable (unable to be removed with surgery), locally advanced (Cancer that has spread from where it started to nearby tissue or lymph nodes) or metastatic (spread of cancer from the primary site (place where it started) to other places in the body) - Do you have archival tumor tissue or willing to undergo a fresh tumor biopsy is none available?

Specialty Area(s)

Bladder Cancer , Colon and Rectal Cancer, Head and Neck/Oral Cancers, Kidney Cancer/Adrenal Cancer, Liver Cancer, Lung cancer, Prostate Cancer, Immunotherapy

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032