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Evaluating XB010 for patients with solid tumors

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

PHASE1 · Exelixis · NCT06545331

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

PhasePHASE1
Study typeInterventional
Enrollment396 (estimated)
Ages18 Years and up
SexAll
SponsorExelixis (industry)
Drugs / interventionspembrolizumab
Locations19 sites (Irvine, California and 18 other locations)
Trial IDNCT06545331 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed inoperable, locally advanced, or metastatic solid tumors.

Not a fit: Patients with early-stage tumors or those who have not exhausted other treatment options may not benefit from this study.

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 performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this novel combination.

Eligibility criteria

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 this trial is running

Irvine, California and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer, Head and Neck Squamous Cell Cancer, NSCLC, Hormone-receptor-positive Breast Cancer, Triple Negative Breast Cancer

Last reviewed 2026-05-15 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.