NCT07123103PHASE1Recruiting
A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
Exelixis
Start Date
8/18/2025
Completion Date
2/1/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DRUG
XB371
Conditions
Solid Tumors
Locations
Exelixis Clinical Site #5
Rogers, Arkansas 72758
United States
Exelixis Clinical Site #9
Los Angeles, California 90033
United States
Exelixis Clinical Site #6
Washington D.C., District of Columbia 20057
United States
Exelixis Clinical Site #4
Orlando, Florida 32827
United States
Exelixis Clinical Site #3
Grand Rapids, Michigan 49546
United States
Exelixis Clinical Site #7
New Brunswick, New Jersey 08901
United States
Exelixis Clinical Site #2
Huntersville, North Carolina 28078
United States
Exelixis Clinical Site #8
Houston, Texas 77030
United States
Exelixis Clinical Site #1
San Antonio, Texas 78229
United States