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.

BA3011-002

The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC

2021-03-17

2025-08-01

2025-08-01

Recruiting

Early phase I

240

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. 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2024-01-31