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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

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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