Study of XB010 in Subjects With Solid Tumors
Recruiting · NCT06545331 · Interventional (participants receive a specific treatment) · Lead sponsor: Exelixis
View the official record on ClinicalTrials.gov →Interventions studied
PembrolizumabXB010
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
* 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.
Where it is running
20 locations listed across 12 US states.
- City of Hope Orange County Lennar Foundation Cancer Center - Irvine, California, United States
- UCLA Department of Medicine - Hematology/Oncology - Los Angeles, California, United States
- Georgetown University Medical Center - Washington D.C., District of Columbia, United States
- Sarah Cannon Research Institute at Florida Cancer Specialists - Orlando, Florida, United States
- Winship Cancer Institute - Atlanta, Georgia, United States
- University of Chicago Medical Center - Chicago, Illinois, United States
- Siteman Cancer Center - St Louis, Missouri, United States
- Montefiore Medical Center - Montefiore Medical Park - The Bronx, New York, United States
- Carolina BioOncology Institute - Huntersville, North Carolina, United States
- Stephenson Cancer Center - Oklahoma City, Oklahoma, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- NEXT Austin - Austin, Texas, United States
- Baylor University Medical Center - Dallas, Texas, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Inova Schar Cancer - Fairfax, Virginia, United States
- NEXT Virginia - Fairfax, Virginia, United States
- University Hospitals of Leicester NHS Trust - Leicester, United Kingdom
- Sarah Cannon Research Institute London - London, United Kingdom
- University College London Hospitals NHS Foundation Trust - London, United Kingdom
- The Christie NHS Foundation Trust - Manchester, United Kingdom