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
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Agent(s): BA3011
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Disease Type(s): Lung-NSCLC
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Phase(s): II
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Drug Classification(s): Targeted Therapy, Antibody Drug Conjugate
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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.
Purpose
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
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
