NCT07123103 · Exelixis
A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
What this study is about
The primary purpose of the study is to characterize the safety and how well patients handle the treatment of XB371. The gradually increasing doses cohorts and Part B of the expansion cohorts are non-randomly assigned. Part A of the expansion cohorts is randomly assigned.
View original scientific description
The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts are non-randomized. Part A of the expansion cohorts is randomized.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Rogers, Arkansas
- Los Angeles, California
- Washington D.C., District of Columbia
- Orlando, Florida
- Grand Rapids, Michigan
- New Brunswick, New Jersey
- Huntersville, North Carolina
- Houston, Texas
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations