RecruitingRecruiting
Study of XB010 in Subjects With Solid Tumors
NCT06545331 · Exelixis
In plain English
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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: 2026-06-22
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 (20)
City of Hope Orange County Lennar Foundation Cancer CenterRecruiting
Irvine, California, United States
UCLA Department of Medicine - Hematology/OncologyRecruiting
Los Angeles, California, United States
Georgetown University Medical CenterRecruiting
Washington D.C., District of Columbia, United States
Sarah Cannon Research Institute at Florida Cancer SpecialistsRecruiting
Orlando, Florida, United States
Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Siteman Cancer CenterRecruiting
St Louis, Missouri, United States
Montefiore Medical Center - Montefiore Medical ParkRecruiting
The Bronx, New York, United States
Carolina BioOncology InstituteRecruiting
Huntersville, North Carolina, United States
Stephenson Cancer CenterRecruiting
Oklahoma City, Oklahoma, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
NEXT AustinRecruiting
Austin, Texas, United States
Baylor University Medical CenterRecruiting
Dallas, Texas, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Inova Schar CancerRecruiting
Fairfax, Virginia, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States
University Hospitals of Leicester NHS TrustRecruiting
Leicester, United Kingdom
Sarah Cannon Research Institute LondonRecruiting
London, United Kingdom
University College London Hospitals NHS Foundation TrustRecruiting
London, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, United Kingdom