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/L1, EGFR, or ALK Inhibitor

BioAtla Inc.0 个研究点目标入组 280 人开始时间: 2022年6月17日最近更新: 2024年1月8日

适应症

试验速览

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•Patients must:
•- Have histologically or cytologically confirmed locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC).
•- Age = 18 Year.
•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•- Clinically significant cardiac disease.
•- Known non-controlled central nervous system (CNS) metastasis.
•- Prior therapy with a conjugated or unconjugated auristatin derivative / vinca-binding site targeting payload.
•- 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.
•- Major surgery within 4 weeks before first BA3011 administration.
•- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
•- Women who are pregnant or breast feeding

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