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A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors

RECRUITINGPhase 1Sponsored by Exelixis
Actively Recruiting
PhasePhase 1
SponsorExelixis
Started2025-08-18
Est. completion2027-11
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations9 sites

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

CancerSolid Tumors

Locations9 sites

Exelixis Clinical Site #5
Rogers, Arkansas, 72758
Exelixis Clinical Site #9
Los Angeles, California, 90033
Exelixis Clinical Site #6
Washington D.C., District of Columbia, 20057
Exelixis Clinical Site #4
Orlando, Florida, 32827
Exelixis Clinical Site #3
Grand Rapids, Michigan, 49546

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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