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Study of XB010 in Subjects With Solid Tumors

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Exelixis · Participants: 396 · Started: Aug 6, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06545331

Locations in the U.S.

CaliforniaCity of Hope Orange County Lennar Foundation Cancer Center, Irvine
UCLA Department of Medicine - Hematology/Oncology, Los Angeles
District of ColumbiaGeorgetown University Medical Center, Washington D.C.
FloridaSarah Cannon Research Institute at Florida Cancer Specialists, Orlando
GeorgiaWinship Cancer Institute, Atlanta
IllinoisUniversity of Chicago Medical Center, Chicago
MissouriSiteman Cancer Center, St Louis
New YorkMontefiore Medical Center - Montefiore Medical Park, The Bronx
North CarolinaCarolina BioOncology Institute, Huntersville
OklahomaStephenson Cancer Center, Oklahoma City
TennesseeSCRI Oncology Partners, Nashville
TexasNEXT Austin, Austin
Baylor University Medical Center, Dallas
University of Texas MD Anderson Cancer Center, Houston
VirginiaInova Schar Cancer, Fairfax
NEXT Virginia, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.