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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

Sponsor: Exelixis · Participants: 150 · Started: Aug 18, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07123103

Locations in the U.S.

ArkansasExelixis Clinical Site #5, Rogers
CaliforniaExelixis Clinical Site #9, Los Angeles
District of ColumbiaExelixis Clinical Site #6, Washington D.C.
FloridaExelixis Clinical Site #4, Orlando
MichiganExelixis Clinical Site #3, Grand Rapids
New JerseyExelixis Clinical Site #7, New Brunswick
North CarolinaExelixis Clinical Site #2, Huntersville
TexasExelixis Clinical Site #8, Houston
Exelixis Clinical Site #1, San Antonio

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.