CAB-AXL-ADC Safety and Efficacy Study in Adults with NSCLC
- Conditions
- Non-Small-Cell Lung Cancer
- Interventions
- Biological: PD-1 inhibitor
- Registration Number
- NCT04681131
- Lead Sponsor
- BioAtla, Inc.
- 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-targeted antibody drug conjugate (CAB-AXL-ADC), alone and in combination with PD-1 inhibitor in patients with metastatic non-small cell lung cancer (NSCLC).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAB-AXL-ADC (BA3011) CAB-AXL-ADC CAB-AXL-ADC (BA3011) alone CAB-AXL-ADC (BA3011)+PD-1 inhibitor CAB-AXL-ADC CAB-AXL-ADC (BA3011) with PD-1 inhibitor CAB-AXL-ADC (BA3011)+PD-1 inhibitor PD-1 inhibitor CAB-AXL-ADC (BA3011) with PD-1 inhibitor
- Primary Outcome Measures
Name Time Method Confirmed Objective Response Rate (ORR) per RECIST v1.1 Up to 24 months Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Incidence of Adverse Events (AEs)or Serious Adverse Events (SAEs) as assessed by CTCAE v4.03/v5 Up to 24 months Measured by frequency and severity of adverse events as assessed by CTCAE v4.03/v5
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) Up to 24 months Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first
Progression-free survival (PFS) Up to 24 months Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first.
Best overall response (BOR) Up to 24 months All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Disease control rate (DCR) Up to 24 months Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks.
Time to response (TTR) Up to 24 months Time from the first dose of investigational product until the first documentation of OR.
Percent change from baseline in target lesion sum of diameters Up to 24 months Overall survival (OS) Up to 24 months Time from the first dose of BA3021 treatment until death due to any cause.
Trial Locations
- Locations (59)
City of Hope - Duarte
🇺🇸Duarte, California, United States
University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center
🇺🇸Irvine, California, United States
California Research Institute
🇺🇸Los angeles, California, United States
USC Norris
🇺🇸Los angeles, California, United States
Cedars-Sinai
🇺🇸Los Angeles, California, United States
University of California, San Diego (UCSD) - Moores Cancer Center
🇺🇸San Diego, California, United States
American Institute of Research
🇺🇸Whittier, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Florida Cancer Specialists & Research Institute
🇺🇸Fort Myers, Florida, United States
Florida Cancer Specialist
🇺🇸Saint Petersburg, Florida, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Florida Cancer Specialists
🇺🇸West Palm Beach, Florida, United States
Augusta University - Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Baptist Health Systems
🇺🇸Lexington, Kentucky, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Norton Cancer Institute, Brownsboro Hospital Campus
🇺🇸Louisville, Kentucky, United States
Hematology/Oncology Clinic
🇺🇸Baton Rouge, Louisiana, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
OptumCare Cancer Care
🇺🇸Las Vegas, Nevada, United States
Roswell Park
🇺🇸Buffalo, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
FirstHealth Outpatient Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Gabrail Cancer Research Center
🇺🇸Canton, Ohio, United States
The Lindner Research Center at the Christ Hospital
🇺🇸Cincinnati, Ohio, United States
UPMC Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina- Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
MD Anderson
🇺🇸Houston, Texas, United States
Henry Dunant Hospital Center
🇬🇷Athens, Greece
Metropolitan Hospital Perseus Healthcare Group SA
🇬🇷Piraeus, Greece
Bioclinic Thessaloniki
🇬🇷Thessaloniki, Greece
European Interbalkan Medical Center
🇬🇷Thessaloniki, Greece
ICON Cancer Centre
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Hong Kong United Oncology Centre
🇭🇰Kowloon, Hong Kong
"IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."
🇮🇹Genoa, Liguria, Italy
Hospital San Giuseppe Moscati
🇮🇹Avellino, Italy
European Institute of Oncology (IEO), IRCCS
🇮🇹Milan, Italy
Santa Maria delle Croci Hospital of Ravenna
🇮🇹Ravenna, Italy
Integrated University Hospital of Verona
🇮🇹Verona, Italy
Specialistic Oncologic Hospital NU-MED
🇵🇱Tomaszów Mazowiecki, Lodzkie, Poland
Polish Mother's Memorial Hospital-Research Institute
🇵🇱Łódź, Lodzkie, Poland
Institute of Genetics and Immunology GENIM
🇵🇱Lublin, Lubelskie, Poland
MED-Polonia, Sp. z o.o. (LLC)
🇵🇱Poznań, Wielkopolskie, Poland
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Andalusia, Spain
Hospital del Mar
🇪🇸Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Catalonia, Spain
Catalan Institute of Oncology, Hospital Duran i Reynals
🇪🇸Barcelona, Catalonia, Spain
Maria Sklodowska-Curie - National Research Institute of Oncology
🇵🇱Warsaw, Mazowieckie, Poland
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
University Hospital 12 de Octubre
🇪🇸Madrid, Spain
Kaoshiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan