Clinicaltrials.gov identifier:
NCT05932862 (https://clinicaltrials.gov/show/NCT05932862)
Treatment
Treatment study for people with advanced solid tumors
Study Contact Information:
Please contact Exelixis Clinical Trials by phone 1-888-393-5494 or email medinfo@exelixis.com
The study will test if an investigational treatment, XL309, is safe and works when used alone or in combination with a PARP inhibitor to treat people with some advanced solid tumors. The study is looking to enroll adults with certain types of cancer, including those with:
XL309 is an inhibitor that blocks an enzyme called USP1. Blocking USP1 in cancer cells may prevent tumors from repairing their damaged DNA, causing the cancer cells to die.
Some people in the study will be treated with XL309 in combination with olaparib. Olaparib is an inhibitor that blocks an enzyme called PARP. Olaparib is approved to treat certain cancers, including some forms of breast cancer, ovarian cancer, pancreatic cancer and prostate cancer.
The use of XL309, alone or in combination with olaparib, is being investigated in this clinical trial and has not been approved by the FDA. Safety and efficacy have not been established and are being studied as part of this trial.
This is a phase 1, open-label study, which means if you take part in the study, you and your doctor will know which drug(s) are being given. The study will be run in two different parts:
If you are eligible and decide to take part in the XL309 study:
The time between visits will depend on which part of the study you join.
Talk to your doctor to learn more about this study and if it may be an option for you.
Florida
Orlando
Florida Cancer Specialists & Research Institute
Missouri
Kansas City
St. Luke's Cancer Institute
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
New York
New York City
Icahn School of Medicine at Mount Sinai
Ohio
Cleveland
University Hospitals Cleveland Medical Center
Tennessee
Germantown
West Cancer Center
Nashville
SCRI Oncology Partners
Texas
Austin
Next Oncology
Houston
MD Anderson Cancer Center
San Antonio
Next Oncology
People may be eligible who:
Note: If you had treatment with a PARP inhibitor before, you may be eligible for the study. Talk to the study doctor about how your body tolerated prior PARP inhibitor therapy to see if you are eligible for this study treatment.
There are other requirements to participate in this study. The study doctor will help determine if this study is right for you.
People may not be eligible who:
There are other requirements to participate in this study. The study doctor will help determine if this study is right for you.
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.