Study of XB010 in Subjects With Solid Tumors
Start Date
8/6/2024
Completion Date
10/20/2027
Summary
This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.
Detailed Description
This study consists of Dose-Escalation and Cohort-Expansion Stages. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]) of XB010 as a single agent, and to evaluate XB010 monotherapy RDE(s) in combination with pembrolizumab. The Cohort-Expansion Stage is designed to explore the clinical activity and further characterize the safety and tolerability of XB010 as monotherapy in multiple tumor-specific cohorts.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
XB010
Pembrolizumab
Conditions
Locations
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California 91010
United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California 90095
United States
Georgetown University Medical Center
Washington D.C., District of Columbia 20007
United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida 32827
United States
Winship Cancer Institute
Atlanta, Georgia 30322
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Siteman Cancer Center
St Louis, Missouri 63110
United States
Montefiore Medical Center - Montefiore Medical Park
The Bronx, New York 10461
United States
Carolina BioOncology Institute
Huntersville, North Carolina 28078
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
NEXT Austin
Austin, Texas 78758
United States
Baylor University Medical Center
Dallas, Texas 75246
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Inova Schar Cancer
Fairfax, Virginia 22031
United States
NEXT Virginia
Fairfax, Virginia 22031
United States
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
United Kingdom
Sarah Cannon Research Institute London
London, W1G 6AD
United Kingdom
University College London Hospitals NHS Foundation Trust
London, W1T 7HA
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom