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

Inclusion Criteria

• Patients must have measurable disease.
• Age ≥ 18 years (Phase 1); 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.

Exclusion Criteria

• Patients must not have clinically significant cardiac disease.
• Patients must not have known non-controlled CNS metastasis.
• Patients must not have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first BA3011 administration. (Phase 1 only)
• Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
• Patients must not have Grade 2 or higher peripheral neuropathy.
• 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.

This is a multi-center, open-label, Phase 1/2 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) in patients with advanced solid tumors in Phase 1 and BA3011 alone and in combination with nivolumab in Phase 2. Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (still enrolling). Phase 2 is targeted to begin in Q3 2020 and will include both adult and adolescents age 12 and over.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
BioAtla, LLC

• Primary ID BA3011-001
• Secondary IDs NCI-2018-01012
• Clinicaltrials.gov ID NCT03425279