Status:
RECRUITING
Study of XB010 in Subjects With Solid Tumors
Lead Sponsor:
Exelixis
Conditions:
Locally Advanced or Metastatic Solid Tumors
Esophageal Squamous Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 lo...
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\...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2027
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT06545331
Start Date
August 6 2024
End Date
October 20 2027
Last Update
November 28 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Exelixis Clinical Site #4
Duarte, California, United States, 91010
2
Exelixis Clinical Site #10
Washington D.C., District of Columbia, United States, 20007
3
Exelixis Clinical Site #12
Atlanta, Georgia, United States, 30322
4
Exelixis Clinical Site #5
St Louis, Missouri, United States, 63110