A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
Summary
The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.
Arms & interventions
- BiologicalXmAb541
Monoclonal bispecific antibody
Outcome measures
Primary
Incidence of adverse events
Time frame: Day 1 to 2 years
Incidence of dose-limiting toxicities (DLTs)
Time frame: Day 1 to Day 28
Incidence of cytokine release syndrome (CRS)
Time frame: Day 1 to Day 28
Secondary
Measurement of Cmax
Time frame: Day 1 to 2 years
Measurement of area under curve (AUC)
Time frame: Day 1 to 1.4 years
Measurement of Ctrough
Time frame: Day 1 to 2 years
Objective Response Rate
Time frame: Day 1 to 2 years
Duration of Response
Time frame: Day 1 to 2 years
Changes in Circulating Tumor DNA (ctDNA)
Time frame: Day 1 to 4 months
Eligibility criteria
Study locations (17)
City of Hope
Duarte, California, 91010
Stanford
Palo Alto, California, 94304
University of California
San Francisco, California, 94158
Moffitt Cancer Center
Tampa, Florida, 33612
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
University of Chicago Medical Center
Chicago, Illinois, 60637
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Minnesota
Minneapolis, Minnesota, 55455
The John Theruer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
The Ohio State University
Columbus, Ohio, 43210
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
SCRI Oncology Partners
Nashville, Tennessee, 37203
University of Virginia
Charlottesville, Virginia, 22903