NCT06545331RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 396 (estimated)
- First submitted
- 29 Jul 2024
- Start date
- 6 Aug 2024
- Primary completion date
- 23 Nov 2026
- Lead sponsor
- Exelixis
- NCT number
- NCT06545331
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 396
- From 6 Aug 2024 to the primary completion date, 23 Nov 2026
- 20 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals of Leicester NHS Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| Sarah Cannon Research Institute London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| NEXT Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Baylor University Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Inova Schar Cancer Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Carolina Biooncology Institute Coordinator of this site? Confirm its status | Huntersville | United States | Completed |
| City of Hope Orange County Lennar Foundation Cancer Center Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| UCLA Department of Medicine - Hematology/Oncology Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Stephenson Cancer Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Sarah Cannon Research Institute at Florida Cancer Specialists Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Siteman Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Montefiore Medical Center- Montefiore Medical Park Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Georgetown University Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.