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RecruitingPhase 1NCT06545331
Official study title

Study of XB010 in Subjects With Solid Tumors

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedXB010 and Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 15, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?20 U.S. locations

Locations may change over time.

Who runs it?Exelixis

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Exelixis
Interventions being studied
Drug: XB010; Drug: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope Orange County Lennar Foundation Cancer CenterIrvine, California
  • UCLA Department of Medicine - Hematology/OncologyLos Angeles, California
  • Georgetown University Medical CenterWashington D.C., District of Columbia
  • Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlando, Florida
  • Winship Cancer InstituteAtlanta, Georgia
  • University of Chicago Medical CenterChicago, Illinois
  • Siteman Cancer CenterSt Louis, Missouri
  • Montefiore Medical Center - Montefiore Medical ParkThe Bronx, New York
  • Carolina BioOncology InstituteHuntersville, North Carolina
  • Stephenson Cancer CenterOklahoma City, Oklahoma
  • SCRI Oncology PartnersNashville, Tennessee
  • NEXT AustinAustin, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 15, 2026. Always confirm current availability with the study team.

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