Evaluating XB010 for patients with solid tumors
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
Run by Exelixis · NCT06545331 · Data updated 2026-11-12
This study is testing a new drug called XB010, alone and with another medication, to see if it can help people with advanced solid tumors who have few other treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 396 (estimated) |
| Sponsor | Exelixis Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 20 sites (Irvine, California and 19 other locations) |
| Status | Recruiting |
| Started | August 6, 2024 |
| Main results expected | November 23, 2026 |
| Study ends | October 20, 2027 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT06545331 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with confirmed inoperable, locally advanced, or metastatic solid tumors.
✕Probably not a fit
Patients with early-stage tumors or those who have not exhausted other treatment options may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety and effectiveness of XB010, both alone and in combination with pembrolizumab, in patients with locally advanced or metastatic solid tumors who have limited treatment options. It includes a Dose-Escalation Stage to identify the maximum tolerated dose and a Cohort-Expansion Stage to assess the drug's clinical activity across various tumor types. Participants will be monitored for safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.
How similar studies have gone: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this novel combination.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States Recruiting -
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States Recruiting -
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States Recruiting -
Winship Cancer Institute
Atlanta, Georgia, United States Recruiting -
University of Chicago Medical Center
Chicago, Illinois, United States Recruiting -
Siteman Cancer Center
St Louis, Missouri, United States Recruiting
Show 14 more locations
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Montefiore Medical Center - Montefiore Medical Park
The Bronx, New York, United States Recruiting -
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States Recruiting -
SCRI Oncology Partners
Nashville, Tennessee, United States Recruiting -
NEXT Austin
Austin, Texas, United States Recruiting -
Baylor University Medical Center
Dallas, Texas, United States Recruiting -
University of Texas MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
Inova Schar Cancer
Fairfax, Virginia, United States Recruiting -
NEXT Virginia
Fairfax, Virginia, United States Recruiting -
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom Recruiting -
Sarah Cannon Research Institute London
London, United Kingdom Recruiting -
University College London Hospitals NHS Foundation Trust
London, United Kingdom Recruiting -
The Christie NHS Foundation Trust
Manchester, United Kingdom Recruiting -
Georgetown University Medical Center
Washington D.C., District of Columbia, United States Completed -
Carolina BioOncology Institute
Huntersville, North Carolina, United States Completed
Study contacts
- Study coordinator: Exelixis Clinical Trials
- Email: druginfo@exelixis.com
- Phone: 1-888-EXELIXIS (888-393-5494)
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This phase 1 trial will try EPI-326, a new drug, in people with EGFR-mutant non‑small cell lung cancer or advanced head and neck squamous cell carcinoma to find safe doses, study how the body handles it, and look for early signs it shrinks tumors.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.