A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination with Pembrolizumab in Advanced Solid Tumors

UVA Tracking #
HSR230132
Principal Investigator
Matthew J Reilley
Contact
Contact Phone
Official Trial Title
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination with Pembrolizumab in Advanced Solid Tumors
Study Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with advanced solid tumors to participate in a research study. The study will test the safety and tolerability of an investigational drug called XmAb662 alone or XmAb662 given in combination with pembrolizumab. XmAb662 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 determine the effect, good and/or bad, the investigational drug has on your cancer by testing different dose levels.

The study involves receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, having your blood drawn, and talking to the study doctor. Participation includes a screening period before receiving the study treatment, 3 visits per cycle during treatment (5 visits in cycle 1, and 4 visits in cycle 2), an end of treatment visit, and a follow-up period via phone calls to keep track of how you are doing. Treatment cycles for this study are 21 days. Your total length of time in the study will depend upon the number of individual treatment cycles you receive, or until your study doctor thinks you are no longer benefiting from the study treatment.

The investigational drugs, XmAb662 alone or XmAb662 with pembrolizumab, as well as all study-related procedures including doctor's visits and laboratory tests, will be provided at no cost to you.

More information about this study can be found at https://clinicaltrials.gov

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

Mileage Reimbursement - $0.54 cents per mile. Hotel Reimbursement – Eligible if you live 100 miles round trip from UVA