: A dose-escalation and expansion study of the safety and pharmacokinetics of XB002 (an antibody drug conjugate targeting tissue factor) as single-agent and combination therapy in subjects with inoperable locally advanced or metastatic solid tumors

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with advanced or metastatic solid tumors without standard treatment options to participate in a research study. This study will evaluate the investigational drug XB002 alone or in combination with nivolumab or bevacizumab. XB002 is considered an investigational drug for use in this study because it has not been approved by the FDA; its safety and efficacy have not been established. XB002 is used to treat cancer. It is given through a vein or intravenous (IV), and it targets the protein "Tissue Factor" that is found in many cancers. The purpose of this study is to learn about the effects of the study drug XB002 alone and in combination with nivolumab or bevacizumab by testing its safety 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, talking to the study doctor, and answering questionnaires. If you are eligible for the study and consent to participate, your involvement includes a screening visit, 3-5 visits per cycle during treatment, two follow-up visits after treatment, and a follow-up period via phone calls to keep track of how you are doing. Treatment cycles for this study are 21 days. It is estimated that you will be on study treatment for about 4-6 months; however, it is possible that you could receive study treatment for up to 24 months if you are responding to study treatment and are not having tolerable side effects.

The investigational drug, XB002, and nivolumab or bevacizumab if you receive the combination therapy, as well as study related doctor's visits and laboratory tests, will be provided at no cost to you.

Contact: uvacancertrials@hscmail.mcc.virginia.edu

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT04925284