CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC

NCT04681131 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: BA3011-002
• Study Type: interventional
• Target: 85
• Locations: 7 countries
• Sites: 60

Brief Summary

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

Conditions

Non-Small-Cell Lung Cancer

Keywords

Cancer

Outcome Measures

Primary Outcomes (2)

• Confirmed Objective Response Rate (ORR) per RECIST v1.1

  Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1

  Up to 24 months

• Incidence of Adverse Events (AEs)or Serious Adverse Events (SAEs) as assessed by CTCAE v4.03/v5

  Measured by frequency and severity of adverse events as assessed by CTCAE v4.03/v5

  Up to 24 months

Secondary Outcomes (7)

• Duration of response (DOR)

  Up to 24 months

• Progression-free survival (PFS)

  Up to 24 months

• Best overall response (BOR)

  Up to 24 months

• Disease control rate (DCR)

  Up to 24 months

• Time to response (TTR)

  Up to 24 months

Study Arms (2)

CAB-AXL-ADC (BA3011)

EXPERIMENTAL

CAB-AXL-ADC (BA3011) alone

Biological: CAB-AXL-ADC

CAB-AXL-ADC (BA3011)+PD-1 inhibitor

EXPERIMENTAL

CAB-AXL-ADC (BA3011) with PD-1 inhibitor

Biological: CAB-AXL-ADC; Biological: PD-1 inhibitor

Interventions

CAB-AXL-ADC BIOLOGICAL

Conditionally active biologic anti-AXL antibody drug conjugate

Also known as: BA3011

CAB-AXL-ADC (BA3011); CAB-AXL-ADC (BA3011)+PD-1 inhibitor

PD-1 inhibitor BIOLOGICAL

PD-1 inhibitor

CAB-AXL-ADC (BA3011)+PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioAtla, Inc.: lead

Study Sites (60)

City of Hope - Duarte

Duarte, California, 91010, United States

Location

University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center

Irvine, California, 92868, United States

Location

California Research Institute

Los Angeles, California, 90027, United States

Location

USC Norris

Los Angeles, California, 90033, United States

Location

Cedars-Sinai

Los Angeles, California, 90048, United States

Location

University of California, San Diego (UCSD) - Moores Cancer Center

San Diego, California, 92093, United States

Location

American Institute of Research

Whittier, California, 90603, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Florida Cancer Specialists & Research Institute

Fleming Island, Florida, 32003, United States

Location

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, 33916, United States

Location

Florida Cancer Specialist

St. Petersburg, Florida, 33705, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Augusta University - Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

Baptist Health Systems

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Norton Cancer Institute, Brownsboro Hospital Campus

Louisville, Kentucky, 40241, United States

Location

Hematology/Oncology Clinic

Baton Rouge, Louisiana, 70809, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center

Detroit, Michigan, 48202, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89014, United States

Location

OptumCare Cancer Care

Las Vegas, Nevada, 89169, United States

Location

Roswell Park

Buffalo, New York, 14263, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

Gabrail Cancer Research Center

Canton, Ohio, 44718, United States

Location

The Lindner Research Center at the Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

UPMC Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Medical University of South Carolina- Hollings Cancer Center

Charleston, South Carolina, 29407, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Henry Dunant Hospital Center

Athens, 115 26, Greece

Location

Metropolitan Hospital Perseus Healthcare Group SA

Piraeus, 185 47, Greece

Location

Bioclinic Thessaloniki

Thessaloniki, 546 22, Greece

Location

European Interbalkan Medical Center

Thessaloniki, 570 01, Greece

Location

ICON Cancer Centre

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Hong Kong United Oncology Centre

Kowloon, Hong Kong

Location

"IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."

Genoa, Liguria, 16132, Italy

Location

Hospital San Giuseppe Moscati

Avellino, 83100, Italy

Location

European Institute of Oncology (IEO), IRCCS

Milan, 20141, Italy

Location

Santa Maria delle Croci Hospital of Ravenna

Ravenna, 48121, Italy

Location

Integrated University Hospital of Verona

Verona, 37126, Italy

Location

MED-Polonia, Sp. z o.o. (LLC)

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Institute of Genetics and Immunology GENIM

Lublin, Lublin Voivodeship, 20-609, Poland

Location

Maria Sklodowska-Curie - National Research Institute of Oncology

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Polish Mother's Memorial Hospital-Research Institute

Lodz, Łódź Voivodeship, 93-338, Poland

Location

Specialistic Oncologic Hospital NU-MED

Tomaszów Mazowiecki, Łódź Voivodeship, 97-200, Poland

Location

Hospital Universitario Virgen de Valme

Seville, Andalusia, 41014, Spain

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

Catalan Institute of Oncology, Hospital Duran i Reynals

Barcelona, Catalonia, 08908, Spain

Location

University Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Kaoshiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 23, 2020
• Study Start: March 17, 2021
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

GR (4); PL (5); ES (6); TW (5); US (32); IT (5); HK (3)