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RecruitingInterventionalPhase 1

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

NCT ID: NCT07123103Sponsor: ExelixisLast updated: 2026-02-17

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.

Arms & interventions

  • DrugXB371

    Intravenous (IV) infusion.

Outcome measures

Primary

  • Number of Participants with a Dose-limiting Toxicity (DLT)

    Time frame: Up to the end of the first cycle (Up to Day 21 of a 21-day cycle)

  • Number of Participants with a Treatment-emergent Adverse Event (TEAE)

    Time frame: Up to approximately 7 months

Secondary

  • Area Under the Plasma Concentration-time Curve (AUC) of XB371, Total Antibody and Unconjugated Belotecan

    Time frame: Up to approximately 7 months

  • Maximum Observed Plasma Concentration (Cmax) of XB371, Total Antibody and Unconjugated Belotecan

    Time frame: Up to approximately 7 months

  • Time to Maximum Observed Plasma Concentration (Tmax) of XB371, Total Antibody and Unconjugated Belotecan

    Time frame: Up to approximately 7 months

  • Trough Observed Plasma Concentration (Ctrough) of XB371, Total Antibody and Unconjugated Belotecan

    Time frame: Up to approximately 7 months

  • Number of Participants with Antidrug Antibodies to XB371

    Time frame: Up to approximately 7 months

  • Dose-escalation Cohorts Only: Recommended Dose(s) for Expansion

    Time frame: Through completion of dose-escalation (up to approximately 18 months)

  • Dose-expansion Cohorts Only: Objective Response Rate as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Time frame: Up to approximately 18 months

  • Dose-expansion Cohorts Only: Duration of Response as Assessed by the Investigator per RECIST v1.1

    Time frame: Up to approximately 18 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (9)

Exelixis Clinical Site #5

Rogers, Arkansas, 72758

Recruiting

Exelixis Clinical Site #9

Los Angeles, California, 90033

Recruiting

Exelixis Clinical Site #6

Washington D.C., District of Columbia, 20057

Recruiting

Exelixis Clinical Site #4

Orlando, Florida, 32827

Recruiting

Exelixis Clinical Site #3

Grand Rapids, Michigan, 49546

Recruiting

Exelixis Clinical Site #7

New Brunswick, New Jersey, 08901

Recruiting

Exelixis Clinical Site #2

Huntersville, North Carolina, 28078

Recruiting

Exelixis Clinical Site #8

Houston, Texas, 77030

Recruiting

Exelixis Clinical Site #1

San Antonio, Texas, 78229

Recruiting