Title
CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors
Phase
Phase 1/Phase 2Lead Sponsor
BioAtla, LLCStudy Type
InterventionalStatus
RecruitingIndication/Condition
Liposarcoma Synovial Sarcoma Carcinoma, Non-Small-Cell Lung Leiomyosarcoma Melanoma Neoplasms Sarcoma Sarcoma, Ewing Osteosarcoma ...Intervention/Treatment
CAB-AXL-ADC ...Study Participants
120The 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
PD-1 inhibitor
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.
Phase 2: BA3011 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.