XB371 for people with locally advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label study administers XB371 to adults with recurrent locally advanced or metastatic solid tumors to characterize safety and tolerability. The design includes dose-escalation cohorts and expansion cohorts, with Part A of the expansion randomized and dose-escalation and Part B of the expansion non-randomized. Eligible participants must have ECOG performance status 0–1, adequate organ and bone marrow function, and a life expectancy of at least 12 weeks, while key exclusions include active brain metastases, interstitial lung disease, uncontrolled infections, recent major surgery or radiation, and recent systemic anticancer therapy. Dosing and safety monitoring occur at Exelixis clinical sites in the United States with regular clinic visits and adverse event assessments.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Minimum life expectancy of ≥ 12 weeks.
* Recurrent locally advanced or metastatic solid tumors.
* Adequate end organ and bone marrow function.

Key Exclusion Criteria:

* Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease.
* History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia.
* Has acute ocular infection, acute or chronic ulcerative/cicatricial condition of conjunctiva or cornea.
* Known history of immunodeficiency virus (HIV) unless specific criteria are met.
* Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody.
* Major surgery within 4 weeks before the first dose of study treatment.
* Received radiation therapy within 2 weeks before the first dose of study treatment.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• Exelixis Clinical Site #5
  Rogers, Arkansas, United States Recruiting
• Exelixis Clinical Site #9
  Los Angeles, California, United States Recruiting
• Exelixis Clinical Site #6
  Washington D.C., District of Columbia, United States Recruiting
• Exelixis Clinical Site #4
  Orlando, Florida, United States Recruiting
• Exelixis Clinical Site #3
  Grand Rapids, Michigan, United States Recruiting
• Exelixis Clinical Site #7
  New Brunswick, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Exelixis Clinical Trials
• Email: druginfo@exelixis.com
• Phone: 1-888-EXELIXIS (888-393-5494)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.