Clinical trial Recruiting at 18 sites Phase 1 Interventional Ages 18 and up

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

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment396 (estimated)
SponsorExelixis
Industry-sponsored
Drugs / interventionspembrolizumab
Locations20 sites (Irvine, California and 19 other locations)
StatusRecruiting
StartedAugust 6, 2024
Main results expectedNovember 23, 2026
Study endsOctober 20, 2027
Registry record updatedOctober 30, 2026
Trial IDNCT06545331 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.