XB371 for people with locally advanced or metastatic solid tumors

A Dose Escalation and Expansion Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors

This trial will test whether XB371 is safe and tolerable in people with locally advanced or metastatic solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Exelixis (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 9 sites (Rogers, Arkansas and 8 other locations)
• Trial ID: NCT07123103 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with recurrent locally advanced or metastatic solid tumors who have ECOG 0–1, adequate organ and marrow function, and a life expectancy of at least 12 weeks are the intended candidates.

Not a fit: Patients with active brain metastases, a history of interstitial lung disease, active hepatitis C infection, significant ocular disease, poor performance status, or recent major surgery, radiation, or systemic anticancer therapy may not receive benefit or may be excluded.

Why it matters

Potential benefit: If XB371 proves safe and shows preliminary activity, it could become a new treatment option or lead to later studies that improve outcomes for some patients with advanced solid tumors.

How similar studies have performed: As an early Phase 1 clinical test of an investigational agent, XB371's activity in patients is unproven, though some other early dose-escalation cancer studies have led to effective treatments in later phases.

Eligibility criteria

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 this trial is running

Rogers, Arkansas and 8 other locations

• 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)
• Exelixis Clinical Site #2 — Huntersville, North Carolina, United States (Recruiting)
• Exelixis Clinical Site #8 — Houston, Texas, United States (Recruiting)
• Exelixis Clinical Site #1 — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Exelixis Clinical Trials

Conditions Solid Tumors; Advanced Solid Tumors; Metastatic Solid Tumors