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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
396
IV administration of XB010
IV administration of Pembrolizumab
Exelixis Clinical Site #4
Irvine, California, United States
RECRUITINGExelixis Clinical Site #10
Washington D.C., District of Columbia, United States
RECRUITINGExelixis Clinical Site #12
Atlanta, Georgia, United States
RECRUITINGExelixis Clinical Site #15
Chicago, Illinois, United States
RECRUITINGExelixis Clinical Site #5
St Louis, Missouri, United States
RECRUITINGExelixis Clinical Site #3
Huntersville, North Carolina, United States
RECRUITINGExelixis Clinical Site #6
Oklahoma City, Oklahoma, United States
RECRUITINGExelixis Clinical Site #9
Nashville, Tennessee, United States
RECRUITINGExelixis Clinical Site #1
Austin, Texas, United States
RECRUITINGExelixis Clinical Site #7
Dallas, Texas, United States
RECRUITING...and 5 more locations
Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010
To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy.
Time frame: 18 months
Dose-Escalation Stage: Safety of XB010
To evaluate the safety of XB010 alone and in combination therapy through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs)
Time frame: 18 months
Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability]
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component
Time frame: 18 months
Dose-Escalation Stage: Dose intensity of XB010 [Tolerability]
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component
Time frame: 18 months
Cohort-Expansion Stage: Preliminary antitumor activity of XB010
Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1
Time frame: 24 months
Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010
To evaluate the maximum plasma concentration of XB010 alone and in combination.
Time frame: 18 Months
Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010
To evaluate the time to maximum plasma concentration of XB010 alone and in combination.
Time frame: 18 Months
Dose-Escalation Stage: Clearance of XB010
To evaluate the volume of plasma cleared of XB010 alone and in combination for a specified time period
Time frame: 18 Months
Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010
To measure the Area Under the Plasma Concentration Curve of XB010 alone and in combination
Time frame: 18 Months
Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010
To evaluate the minimum plasma concentration of XB010 alone and in combination
Time frame: 18 Months
Dose-Escalation Stage: Immunogenicity of XB010
To assess the immunogenicity of XB010 alone and in combination as measured by anti-drug antibody (ADA) analysis
Time frame: 18 Months
Cohort-Expansion Stage: Duration of exposure of XB010 [Tolerability]
To evaluate the tolerability of XB010 through the evaluation of the duration of exposure
Time frame: 24 Months
Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability]
To evaluate the tolerability of XB010 through the evaluation of the dose intensity
Time frame: 24 Months
Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010
To evaluate the maximum plasma concentration of XB010
Time frame: 24 Months
Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010
To evaluate the time to maximum plasma concentration of XB010
Time frame: 24 Months
Cohort-Expansion Stage: Clearance of XB010
To evaluate the volume of plasma cleared of XB010 for a specified time period
Time frame: 24 Months
Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010
To measure the Area Under the Plasma Concentration Curve of XB010
Time frame: 24 Months
Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010
To evaluate the minimum plasma concentration of XB010
Time frame: 24 Months
Cohort-Expansion Stage: Immunogenicity of XB010
To assess the immunogenicity of XB010 as measured by anti-drug antibody (ADA) analysis
Time frame: 24 Months
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