Phase 2 CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
A Phase 1/ 2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-AXL-ADC, Alone and in Combination With a PD-1 Inhibitor in Adult Patients With Advanced Solid Tumors (Phase 1) and Adult and Adolescent Patients With Advanced, Refractory Sarcoma (Phase 2)
PhasePhase 1/Phase 2
Lead SponsorBioAtla, LLC
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors
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 a PD-1 inhibitor 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 ACC patients only).
Phase 2 is targeted to begin in Q3 2020 and will include both adult and adolescents age 12 and over.
Conditionally active biologic anti-AXL antibody drug conjugate
Phase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.
Inclusion Criteria: 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. Exclusion Criteria: Patients must not have clinically significant cardiac disease. Patients must not have known non-controlled CNS metastasis. Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas 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 administration. Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload. 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.