Study of XB010 in Subjects With Solid Tumors
- Conditions
- Locally Advanced or Metastatic Solid TumorsEsophageal Squamous Cell CancerHead and Neck Squamous Cell CancerNSCLC (Non-small Cell Lung Cancer)Hormone-receptor-positive Breast CancerTriple Negative Breast Cancer (TNBC)
- Interventions
- Registration Number
- NCT06545331
- Lead Sponsor
- Exelixis
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 396
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description XB010 Single-Agent Dose Escalation Cohorts XB010 XB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects XB010 + Pembrolizumab Dose Escalation Cohorts XB010 XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects XB010 + Pembrolizumab Dose Escalation Cohorts Pembrolizumab XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects XB010 Single-Agent Dose Expansion Cohorts XB010 XB010 will be administered at the recommended dose for expansion (RDE) every 3 weeks in the following tumor-specific cohorts: non-small cell lung cancer (NSCLC), hormone-receptor-positive breast cancer (HR+BC), head and neck squamous cell cancer (HNSCC), esophageal squamous cell cancer (ESCC), endometrial cancer (EC) and triple-negative breast cancer (TNBC)
- Primary Outcome Measures
Name Time Method Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010 18 months 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 18 months 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] 18 months 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] 18 months To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component
Cohort-Expansion Stage: Preliminary antitumor activity of XB010 24 months Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1
- Secondary Outcome Measures
Name Time Method Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010 18 Months To evaluate the maximum plasma concentration of XB010 alone and in combination.
Cohort-Expansion Stage: Duration of exposure of XB010 [Tolerability] 24 Months To evaluate the tolerability of XB010 through the evaluation of the duration of exposure
Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010 24 Months To evaluate the maximum plasma concentration of XB010
Cohort-Expansion Stage: Immunogenicity of XB010 24 Months To assess the immunogenicity of XB010 as measured by anti-drug antibody (ADA) analysis
Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010 18 Months To evaluate the time to maximum plasma concentration of XB010 alone and in combination.
Dose-Escalation Stage: Clearance of XB010 18 Months 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 18 Months To measure the Area Under the Plasma Concentration Curve of XB010 alone and in combination
Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability] 24 Months To evaluate the tolerability of XB010 through the evaluation of the dose intensity
Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010 24 Months To evaluate the time to maximum plasma concentration of XB010
Cohort-Expansion Stage: Clearance of XB010 24 Months To evaluate the volume of plasma cleared of XB010 for a specified time period
Dose-Escalation Stage: Immunogenicity of XB010 18 Months To assess the immunogenicity of XB010 alone and in combination as measured by anti-drug antibody (ADA) analysis
Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010 18 Months To evaluate the minimum plasma concentration of XB010 alone and in combination
Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010 24 Months To measure the Area Under the Plasma Concentration Curve of XB010
Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010 24 Months To evaluate the minimum plasma concentration of XB010
Trial Locations
- Locations (8)
Exelixis Clinical Site #7
🇺🇸Dallas, Texas, United States
Exelixis Clinical Site #8
🇺🇸Houston, Texas, United States
Exelixis Clinical Site #4
🇺🇸Duarte, California, United States
Exelixis Clinical Site #5
🇺🇸Saint Louis, Missouri, United States
Exelixis Clinical Site #3
🇺🇸Huntersville, North Carolina, United States
Exelixis Clinical Site #6
🇺🇸Oklahoma City, Oklahoma, United States
Exelixis Clinical Site #1
🇺🇸Austin, Texas, United States
Exelixis Clinical Site #2
🇺🇸Fairfax, Virginia, United States