Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-21-148
Prinicipal Investigator
Joshi, Monika
Phase
Phase I
Age Group
Adult
Scope
National
Secondary Protocol No.
XL092-001
Title
A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Objective
Primary Objectives:
Dose-Escalation Stage: MTD/recommended dose for XL092 [ Time Frame: Up to 24 months ]
To determine the maximum tolerated dose (MTD) and/or recommended dose (RD) for further evaluation of XL092 when administered alone and in combination with immune checkpoint inhibitors (ICIs) to subjects with advanced solid tumors
Cohort-Expansion Stage: Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
To evaluate preliminary efficacy of XL092 when administered alone and in combination with ICIs by estimating ORR as assessed by the Investigator per RECIST 1.1
Cohort-Expansion Stage (except Cohort H): Progression-Free Survival (PFS) [ Time Frame: Up to 24 months ]
To evaluate preliminary efficacy of single-agent XL092 and XL092 in combination with ICIs for specific cohorts by estimating the percentage of subjects with PFS at 6 months (PFS rate) per RECIST 1.1 as assessed by the Investigator
Cohort-Expansion Stage (Cohort H only): Overall Survival (OS) [ Time Frame: Up to 24 months ]
To evaluate preliminary efficacy of single-agent XL092 and XL092 in combination with atezolizumab for subjects with RAS wild-type CRC (Cohort H Treatment Arms H-A and H-B) by estimating overall survival (OS).

Secondary Objectives:
Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 36 months ]
To evaluate the safety of XL092 when administered alone and in combination with ICIs through the evaluation of incidence and severity of nonserious AEs and SAEs, including immune-related adverse events (irAEs), and adverse events of special interest (AESIs)
Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Up to 24 months ]
To evaluate the Tmax of XL092 alone and in combination with ICI
Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) [ Time Frame: Up to 24 months ]
To evaluate the Cmax of XL092 alone and in combination with ICI
Dose-Escalation Stage: Area Under the Plasma Concentration-Time Curve Over the Last 24-hour Dosing Interval (AUC 0-24) [ Time Frame: Up to 24 months ]
To evaluate the AUC 0-24 of XL092 alone and in combination with ICI
Dose-Escalation Stage: Terminal Half-Life [ Time Frame: Up to 24 months ]
To evaluate the terminal half-life of XL092 alone and in combination with ICI
Dose-Escalation Stage: Apparent Clearance (CL/F) [ Time Frame: Up to 24 months ]
To evaluate the CL/F of XL092 alone and in combination with ICI
Applicable Disease Sites
Any Site
Status
Open
Participating Institutions
Hershey Medical Center