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A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
RecruitingPhase 1
A Dose Escalation and Expansion Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
Who can join
Ages 18 and older · All sexes
Full 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.
About the study
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.
What is being tested
- XB371 (drug)
Sponsor: Exelixis · Participants: 150 · Started: Aug 18, 2025
Contact the study team
- Exelixis Clinical Trials · Phone: 1-888-EXELIXIS (888-393-5494)
- Backup or International · Phone: 1-650-837-7400
Official record on ClinicalTrials.gov — NCT07123103
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.