Purpose of this Study
We are doing this study to find out if an investigational drug called XL092 (the study drug) is a safe and effective option on its own or in combination with other anticancer drugs.
Who Can Participate?
Eligibility
Adults ages 18+ who match 1 of the following descriptions:
- Are diagnosed with advanced or metastatic kidney cancer with a clear cell component and have not received prior anticancer drugs; OR
- Are diagnosed with advanced or metastatic kidney cancer with a clear cell component that progressed after receiving first-line anticancer drugs; OR
- Are diagnosed with metastatic prostate cancer that progressed after receiving hormone therapy; OR
- Are diagnosed with advanced or metastatic bladder cancer that progressed after chemotherapy and who have not received more than 1 previous anticancer therapy; OR
- Are diagnosed with advanced or metastatic bladder cancer that progressed after PD-1/L1 therapy and who have not received more than 2 previous anticancer therapies; OR
- Are diagnosed with advanced or metastatic non-clear cell kidney cancer who have not received previous anticancer drugs
For more information about who can join this study, please contact the study team at catrin.davies@duke.edu.
- Are diagnosed with advanced or metastatic kidney cancer with a clear cell component and have not received prior anticancer drugs; OR
- Are diagnosed with advanced or metastatic kidney cancer with a clear cell component that progressed after receiving first-line anticancer drugs; OR
- Are diagnosed with metastatic prostate cancer that progressed after receiving hormone therapy; OR
- Are diagnosed with advanced or metastatic bladder cancer that progressed after chemotherapy and who have not received more than 1 previous anticancer therapy; OR
- Are diagnosed with advanced or metastatic bladder cancer that progressed after PD-1/L1 therapy and who have not received more than 2 previous anticancer therapies; OR
- Are diagnosed with advanced or metastatic non-clear cell kidney cancer who have not received previous anticancer drugs
For more information about who can join this study, please contact the study team at catrin.davies@duke.edu.
What is Involved?
If you choose to join this study, you will be assigned to a study drug regimen. The regimen to which you are assigned will depend on the type of cancer you have and when you join the study. The possible study drug regimens are:
- The study drug on its own
- The study drug + nivolumab
- The study drug + nivolumab and ipilimumab
- Nivolumab and ipilimumab on their own without the study drug
The study drug is a pill that you take once a day. Nivolumab and ipilimumab are intravenous (IV) infusions given in the clinic every 3 weeks.
No matter what study group you are assigned to, you will also:
- Have blood draws and give urine samples
- Have ECGs, which is a test to measure your heart function
- Have imaging tests (CT and/or MRI, and possibly bone and brain scans)
- Provide a tumor tissue sample
- The study drug on its own
- The study drug + nivolumab
- The study drug + nivolumab and ipilimumab
- Nivolumab and ipilimumab on their own without the study drug
The study drug is a pill that you take once a day. Nivolumab and ipilimumab are intravenous (IV) infusions given in the clinic every 3 weeks.
No matter what study group you are assigned to, you will also:
- Have blood draws and give urine samples
- Have ECGs, which is a test to measure your heart function
- Have imaging tests (CT and/or MRI, and possibly bone and brain scans)
- Provide a tumor tissue sample
Study Details
Full 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
Principal Investigator
Daniel
George
Protocol Number
PRO00110667
NCT ID
NCT05176483
Phase
I
Enrollment Status
OPEN TO ACCRUAL