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.
Age 18 years or older on the day of consent.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Adequate organ and marrow function.
Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.
None
Sequential
XB010
DrugIV administration of XB010
Pembrolizumab
DrugIV administration of Pembrolizumab
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.
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)
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
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
Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010
To evaluate the maximum plasma concentration of XB010 alone and in combination.
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.
Dose-Escalation Stage: Clearance of XB010
To evaluate the volume of plasma cleared of XB010 alone and in combination for a specified time period
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
