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Taking people in United StatesPhase 1

Study of XB010 in Subjects With Solid Tumors

Key facts

Where
Atlanta, Austin, Chicago, Dallas, Fairfax, Houston, Huntersville, Irvine, Los Angeles, Nashville, Oklahoma City, Orlando, St Louis, The Bronx, and Washington D.C., United StatesSee the 16 sites
Phase
Phase 1

Where in United States

  • Winship Cancer InstituteAtlanta, United StatesTaking people
  • NEXT AustinAustin, United StatesTaking people
  • University of Chicago Medical CenterChicago, United StatesTaking people
  • Baylor University Medical CenterDallas, United StatesTaking people
  • Inova Schar CancerFairfax, United StatesTaking people
  • NEXT VirginiaFairfax, United StatesTaking people
  • University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
  • Carolina Biooncology InstituteHuntersville, United StatesNo longer taking part
  • City of Hope Orange County Lennar Foundation Cancer CenterIrvine, United StatesTaking people
  • UCLA Department of Medicine - Hematology/OncologyLos Angeles, United StatesTaking people
  • SCRI Oncology PartnersNashville, United StatesTaking people
  • Stephenson Cancer CenterOklahoma City, United StatesTaking people
  • Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlando, United StatesTaking people
  • Siteman Cancer CenterSt Louis, United StatesTaking people
  • Montefiore Medical Center- Montefiore Medical ParkThe Bronx, United StatesTaking people
  • Georgetown University Medical CenterWashington D.C., United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Exelixis
Trial code
NCT06545331
Record updated
30 October 2026
Original description
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.Read full original descriptionShow less

A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors

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.

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.

ClinicalTrials.gov NCT06545331