The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts are non-randomized. Part A of the expansion cohorts is randomized.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Intravenous (IV) infusion.
Exelixis Clinical Site #5
Rogers, Arkansas, United States
RECRUITINGExelixis Clinical Site #9
Los Angeles, California, United States
RECRUITINGNumber of Participants with a Dose-limiting Toxicity (DLT)
Time frame: Up to the end of the first cycle (Up to Day 21 of a 21-day cycle)
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Time frame: Up to approximately 7 months
Area Under the Plasma Concentration-time Curve (AUC) of XB371, Total Antibody and Unconjugated Belotecan
Time frame: Up to approximately 7 months
Maximum Observed Plasma Concentration (Cmax) of XB371, Total Antibody and Unconjugated Belotecan
Time frame: Up to approximately 7 months
Time to Maximum Observed Plasma Concentration (Tmax) of XB371, Total Antibody and Unconjugated Belotecan
Time frame: Up to approximately 7 months
Trough Observed Plasma Concentration (Ctrough) of XB371, Total Antibody and Unconjugated Belotecan
Time frame: Up to approximately 7 months
Number of Participants with Antidrug Antibodies to XB371
Time frame: Up to approximately 7 months
Dose-escalation Cohorts Only: Recommended Dose(s) for Expansion
Time frame: Through completion of dose-escalation (up to approximately 18 months)
Dose-expansion Cohorts Only: Objective Response Rate as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Up to approximately 18 months
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Exelixis Clinical Site #6
Washington D.C., District of Columbia, United States
Exelixis Clinical Site #4
Orlando, Florida, United States
RECRUITINGExelixis Clinical Site #3
Grand Rapids, Michigan, United States
RECRUITINGExelixis Clinical Site #7
New Brunswick, New Jersey, United States
RECRUITINGExelixis Clinical Site #2
Huntersville, North Carolina, United States
RECRUITINGExelixis Clinical Site #8
Houston, Texas, United States
RECRUITINGExelixis Clinical Site #1
San Antonio, Texas, United States
RECRUITINGDose-expansion Cohorts Only: Duration of Response as Assessed by the Investigator per RECIST v1.1
Time frame: Up to approximately 18 months