A Phase 2 Study of Mecbotamab Vedotin (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/L-1, EGFR, or ALK Inhibitor
A Phase 2 Study of Mecbotamab Vedotin (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/L-1, EGFR, or ALK Inhibitor
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.
Purpose
- About the safety and tolerability of the study agent alone or in combination with Nivolumab• How proteins that indicate the status of your disease are affected with use of the study agent
- If the study agent alone or in combination with Nivolumab prevents or delays tumor growth or shrinks existing tumors
- How quickly the study agent is removed from your blood
- 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.
- 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.
Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload
Location
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