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Clinical Trial 21941

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04681131

Phase: Phase II
Principal Investigator: Saltos, Andreas

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Study Title

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


This 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).


Primary: * To assess antitumor activity of BA3011 alone and in combination with nivolumab. * To assess the safety of BA3011 alone and in combination with nivolumab. Secondary: * To further characterize the clinical activity of BA3011 alone and in combination with nivolumab.



Immunotherapy; Therapy (NOS)


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

Inclusion Criteria

Inclusion Criteria:

  • Patients must have measurable disease.
  • Age ≥ 18 years
  • 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 may apply

  • Exclusion Criteria

    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.
  • Other criteria may apply

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