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

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

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.