Status:
COMPLETED
CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC
Lead Sponsor:
BioAtla, Inc.
Conditions:
Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC
Detailed Description
This is a multi-center, open-label, Phase 2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3011, a conditionally active biologic (CAB) AXL-targete...
Eligibility Criteria
Inclusion
- Patients must have measurable disease.
- Age ≥ 18 years
- 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
- Patients must not have clinically significant cardiac disease.
- Patients must not have known non-controlled CNS metastasis.
- Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
- 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 had major surgery within 4 weeks before first BA3011
- 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.
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2025
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04681131
Start Date
March 17 2021
End Date
July 9 2025
Last Update
September 25 2025
Active Locations (60)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope - Duarte
Duarte, California, United States, 91010
2
University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center
Irvine, California, United States, 92868
3
California Research Institute
Los Angeles, California, United States, 90027
4
USC Norris
Los Angeles, California, United States, 90033