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  • Cancer Type: Sarcoma
  • Study Type: Treatment
  • NCT#: NCT03425279
  • Phase: Phase I/II
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  • Overview

    Study Title:

    A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 in Patients with Advanced Solid Tumors


    The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors.


    Phase 1 (Dose-Escalation Phase) Objectives: Primary: To define the safety profile, including dose limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), of BA3011 administered every 21 days in patients with advanced solid tumors. Ssecondary: To assess the safety of BA3011. To assess the pharmacokinetics (PK) of BA3011 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3011. Phase 2 (Dose-Expansion Phase) Objectives: Primary: To assess antitumor activity of BA3011 in patients with specified tumor types. To assess the safety of BA3011. Secondary: To assess the PK of BA3011 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3011. Exploratory: To explore the relationship between tumor AXL status and clinical response to BA3011 in patients with specified tumors. To evaluate potential candidate tumor and blood-based biomarkers for patient selection or correlation with antitumor activity of BA3011.

  • Treatments




    BA3011 (Mecbotamab Vedotin); BMS-936558 (Nivolumab); Nivolumab (Opdivo)

  • Inclusion Criteria

      Inclusion Criteria:
    • Patients must have measurable disease.
    • Adequate renal function
    • Adequate liver function
    • Adequate hematological function
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Life expectancy of at least three months.
    • Other criteria apply
  • Exclusion Criteria

      Exclusion Criteria:
    • Clinically significant cardiac disease in the judgment of the investigator.
    • Known non-controlled CNS metastasis.
    • Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.
    • Patients must not have had major surgery within 4 weeks before first BA3011 administration.
    • Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
    • Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
    • Patients must not be women who are pregnant or breast feeding.
    • Other exclusions apply

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