Clinical Trial 19580

• Overview

  Study Title:

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

  Summary:

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

  Objective:

  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

  Therapies:

  Immunotherapy

  Medications:

  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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