Study of XB010 in Subjects With Solid Tumors
NCT Number: NCT06545331
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Locally Advanced or Metastatic Solid Tumors
Interventions: DRUG: XB010|DRUG: Pembrolizumab
Sponsor: Exelixis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-06
Completion Date: 2027-10-20
Locations: Exelixis Clinical Site #3, Huntersville, North Carolina, 28078, United States|Exelixis Clinical Site #1, Austin, Texas, 78758, United States|Exelixis Clinical Site #2, Fairfax, Virginia, 22031, United States

Summary:
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.

Primary Outcome Measures: 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., 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), 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, 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, 18 months|Cohort-Expansion Stage: Preliminary antitumor activity of XB010, Objective Response Rate (ORR), defined as percentage of subjects with a CR or PR, as assessed by the Investigator per RECIST 1.1, 24 months
Secondary Outcome Measures: Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010, To evaluate the maximum plasma concentration of XB010 alone and in combination., 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., 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, 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, 18 Months|Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010, To evaluate the minimum plasma concentration of XB010 alone and in combination, 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, 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, 24 Months|Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability], To evaluate the tolerability of XB010 through the evaluation of the dose intensity, 24 Months|Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010, To evaluate the maximum plasma concentration of XB010, 24 Months|Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010, To evaluate the time to maximum plasma concentration of XB010, 24 Months|Cohort-Expansion Stage: Clearance of XB010, To evaluate the volume of plasma cleared of XB010 for a specified time period, 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, 24 Months|Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010, To evaluate the minimum plasma concentration of XB010, 24 Months|Cohort-Expansion Stage: Immunogenicity of XB010, To assess the immunogenicity of XB010 as measured by anti-drug antibody (ADA) analysis, 24 Months