A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Metastatic Solid Tumors Which Have Progressed Despite Standard Treatments

UVA Tracking #
Principal Investigator
Robert Dreicer
Contact Phone
Official Trial Title
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 Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with metastatic solid tumors which have not responded to standard anti-cancer treatments to participate in a research study. This study will evaluate the investigational drug XL092 alone or in combination with nivolumab, nivolumab plus ipilimumab, or nivolumab/relatlimab fixed dose combination. This is an open label study, which means you, the study doctor, and the Sponsor will know which study treatment you were given. XL092 is considered an investigational drug for use in this study because it has not been approved by the FDA. The purpose of this study is to evaluate potential new anticancer treatments for people with tumors similar to yours, and to test the safety of the study drugs and how your body and your cancer react to the drugs, and if the drugs are effective in treating your type of cancer.

The study involves receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, and talking to the study doctor. If you are eligible for the study and consent to participate, your involvement includes a screening visit, a treatment period where you will visit the clinic at least every 3 or 4 weeks, two follow-up visits after treatment, and a follow-up period via phone calls to keep track of how you are doing. How long you will be on the study depends on your ability to safely tolerate the study treatment, your response to study treatment, and your and/or your study doctor’s decision for you to continue study treatment. It is estimated that you will be on the study for about 6 – 14 months; however, it is possible that you could take part in this study for 2 years or even longer.

The study drugs, XL092, nivolumab and ipilimumab, and nivolumab/relatlimab, will be provided by the sponsor at no cost to you. All additional study procedures, including laboratory tests, physical examinations, and visits to the study center are provided to you at no charge.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05176483



Mileage reimbursement - $0.22 cents per mile Hotel Reimbursement – up to $200 for subjects living greater than 75 miles from the clinic.