A Phase 2 Study of BA3011 Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer Who Had Prior Disease Progression on a PD-1/L1, EGFR, or ALK Inhibitor

Trial summary:

BA3011-002 is a multi-center, open-label, Phase 2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3011, a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC), alone and in combination with PD-1 inhibitor in patients with metastatic non-small cell lung cancer (NSCLC). The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC.

Receptor status / problem studied:

PD-1/ L-1 inhibitor

Inclusion criteria

  • Age ≥ 18 years
  • Patients must have measurable disease:
    • 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).
  • Patients must have:
    • Completed (and recovered from treatment-related toxicities) any prior treatment with radiotherapy, chemotherapy, and/or treatment with other investigational anticancer agents at least 5 half-lives, or 2 weeks, prior to first study dose, or biologics (such as a monoclonal antibody [mAb]) at least 4 weeks prior to first study dose. Exceptions are bisphosphonates, denosumab and gonadotropin-releasing hormone agonist or antagonist.
    • Completed any prior treatment with nitrogen mustard agents, melphalan, or carmustine (BCNU) therapy at least 6 weeks prior to first study dose.
    • Received any prior autologous hematopoietic stem cell infusion at least 8 weeks prior to first study dose.
  • 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.

View more trial information

Open for recruitment

Trial Title



Lung cancer

Type of trial


Type of treatement

Medical Oncology




Principal Investigator
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