CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma

Prior treatment

• Patients must not have had major surgery within 4 weeks before first BA3011 administration.
• Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.

Other illness

• Patients must not have clinically significant cardiac disease.
• 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 known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.

Other

• Patients must not have known non-controlled CNS metastasis.
• Patients must not be women who are pregnant or breast feeding.

• Patients must have measurable disease.
• Age ≥ 12 years (Phase 2)
• 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.