Tests XB010 alone or with pembrolizumab in adults with advanced solid tumors
Tests XB010, alone or with pembrolizumab, in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: 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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a solid tumor that cannot be removed by surgery, has spread, or has come back. It tests XB010 alone and together with pembrolizumab.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Solid tumor confirmed by lab and imaging tests that is inoperable, locally advanced, metastatic, or recurrent. The expansion stage enrolls lung cancer (non-small cell), hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell cancer and triple-negative breast cancer.
- Earlier treatment
- Other treatments do not exist, cannot be tolerated, or no longer work.
Read by machine on 12 November 2026.
Where in United States
- Winship Cancer InstituteAtlanta, United StatesContact: Exelixis Clinical TrialsTaking people
- NEXT AustinAustin, United StatesContact: Exelixis Clinical TrialsTaking people
- University of Chicago Medical CenterChicago, United StatesContact: Exelixis Clinical TrialsTaking people
- Baylor University Medical CenterDallas, United StatesContact: Exelixis Clinical TrialsTaking people
- Inova Schar CancerFairfax, United StatesContact: Exelixis Clinical TrialsTaking people
- NEXT VirginiaFairfax, United StatesContact: Exelixis Clinical TrialsTaking people
- University of Texas - MD Anderson Cancer CenterHouston, United StatesContact: Exelixis Clinical TrialsTaking people
- Carolina Biooncology InstituteHuntersville, United StatesContact: Exelixis Clinical TrialsNo longer taking part
- City of Hope Orange County Lennar Foundation Cancer CenterIrvine, United StatesContact: Exelixis Clinical TrialsTaking people
- UCLA Department of Medicine - Hematology/OncologyLos Angeles, United StatesContact: Exelixis Clinical TrialsTaking people
- SCRI Oncology PartnersNashville, United StatesContact: Exelixis Clinical TrialsTaking people
- Stephenson Cancer CenterOklahoma City, United StatesContact: Exelixis Clinical TrialsTaking people
- Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlando, United StatesContact: Exelixis Clinical TrialsTaking people
- Siteman Cancer CenterSt Louis, United StatesContact: Exelixis Clinical TrialsTaking people
- Montefiore Medical Center- Montefiore Medical ParkThe Bronx, United StatesContact: Exelixis Clinical TrialsTaking people
- Georgetown University Medical CenterWashington D.C., United StatesContact: Exelixis Clinical TrialsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.