A Phase 2 Study of BA3011 Alone and in Combination With PD-1 Inhibitor in Adult Patients With Metastatic Non-small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on a PD-1/L-1 Inhibitor, EGFR, or ALK Inhibitor.
Description
Brief Summary
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC
Detailed Description
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).
Phase
N/AInclusion and Exclusion 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.
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Presentado por
SC CTSI