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

Trial Status: Active

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


University of Colorado Hospital
Status: ACTIVE


Moffitt Cancer Center
Status: ACTIVE
Contact: Jingsong Zhang
Phone: 813-745-1363


Kansas City
University of Kansas Cancer Center
Contact: Adam Hisham Al Douri
Phone: 913-945-7547

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Eileen M. O'Reilly
Phone: 646-888-4182
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

North Carolina

Wake Forest University Health Sciences


Case Comprehensive Cancer Center


OHSU Knight Cancer Institute
Status: ACTIVE


M D Anderson Cancer Center
Status: ACTIVE

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
  • ID NCT03425279