MC# 21-16 - A Phase II Study of BA3011 Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on a PD-1/L1, EGFR, or ALK Inhibitor

  • Agent(s): BA3011
  • Disease Type(s): Lung-NSCLC
  • Phase(s): II
  • Drug Classification(s): Targeted Therapy, Antibody Drug Conjugate
  • Molecular Target(s): AXL

Mechanism of Action

BA3011, an anti-AXL antibody, is designed to have pH-sensitive binding to restrict its activity to the typically acidic tumor microenvironment.  The antibody target is AXL, a transmembrane that may be overexpressed in Non-Small Cell Lung Cancer.


In this study, the sponsor and investigators want to learn:

  • About the safety and tolerability of BA3011 alone or in combination with Nivolumab
  • How proteins that indicate the status of your disease are affected with use of BA3011
  • If BA3011 alone or in combination with Nivolumab prevents or delays tumor growth or shrinks existing tumors
  • How quickly BA3011 is removed from your the blood
Inclusion Criteria
  • Patients must:
    • Have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC.
    • Have prior disease progression on or after receiving an approved PD-1/L1, EGFR, or ALK inhibitor (either monotherapy or in combination with another therapy such as ipilimumab).
  • Patients must have measurable disease
  • Age ≥ 18 years
  • Patients must have AXL-positive disease determined by BioAtla AXL immunohistochemistry (IHC) assay based on biopsy (preferred) or archival tissue; a
  • minimum of 3 core samples are required to ensure a sufficient quantity of cells are obtained. Based on data from Study BA3011-001, a TmPS ≥ 50 (consisting of 1+, 2+, and 3+ intensities) is considered positive 
  • 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
Exclusion Criteria
  • Patients must not have clinically significant cardiac disease
  • Patients must not have known non-controlled CNS metastasis
  • Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload
  • Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as 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
  • 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


  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info:

Contact Us About This Trial

Reach out to us by sharing your info in the form below or give us a call at 972-566-3000.

Re: MC# 21-16