A Dose Escalation and Expansion Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Study Identifier:
XB371-101
CT.gov Identifier:
NCT07123103
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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Study Summary

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

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose-escalation Cohorts
    • Read More
  • Drug: Drug: XB371
  • Drug: Experimental: Dose-expansion Cohorts
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Key
    • * 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.
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor