← Back to searchRecruitingRecruiting
Study of XB010 in Subjects With Solid Tumors
NCT06545331 · Exelixis
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors
About this study
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.
Eligibility criteria
* 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.
* The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).
* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
Study design
Enrollment target: 396 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-08-06
Estimated completion: 2027-10-20
Last updated: 2026-04-15
Interventions
Drug: XB010Drug: Pembrolizumab
Primary outcomes
- • Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010 (18 months)
- • Dose-Escalation Stage: Safety of XB010 (18 months)
- • Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability] (18 months)
Sponsor
Exelixis · industry
Contacts & investigators
ContactExelixis Clinical Trials · contact · druginfo@exelixis.com · 1-888-EXELIXIS (888-393-5494)
ContactBackup or International · contact · 650-837-7400
InvestigatorStudy Director · study_director, Exelixis
All locations (19)
Exelixis Clinical Site #4Recruiting
Irvine, California, United States
Exelixis Clinical Site #19Recruiting
Los Angeles, California, United States
Exelixis Clinical Site #10Recruiting
Washington D.C., District of Columbia, United States
Exelixis Clinical Site #18Recruiting
Orlando, Florida, United States
Exelixis Clinical Site #12Recruiting
Atlanta, Georgia, United States
Exelixis Clinical Site #15Recruiting
Chicago, Illinois, United States
Exelixis Clinical Site #5Recruiting
St Louis, Missouri, United States
Exelixis Clinical Site #3Recruiting
Huntersville, North Carolina, United States
Exelixis Clinical Site #6Recruiting
Oklahoma City, Oklahoma, United States
Exelixis Clinical Site #9Recruiting
Nashville, Tennessee, United States
Exelixis Clinical Site #1Recruiting
Austin, Texas, United States
Exelixis Clinical Site #7Recruiting
Dallas, Texas, United States
Exelixis Clinical Site #8Recruiting
Houston, Texas, United States
Exelixis Clinical Site #11Recruiting
Fairfax, Virginia, United States
Exelixis Clinical Site #2Recruiting
Fairfax, Virginia, United States
Exelixis Clinical Site #17Recruiting
Leicester, England, United Kingdom
Exelixis Clinical Site #13Recruiting
London, England, United Kingdom
Exelixis Clinical Site #16Recruiting
London, England, United Kingdom
Exelixis Clinical Site #14Recruiting
Manchester, England, United Kingdom