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

NCT ID: NCT04681131

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2025-07-09

Brief Summary

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

Detailed Description

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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).

Conditions

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Non-Small-Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAB-AXL-ADC (BA3011)

CAB-AXL-ADC (BA3011) alone

Group Type EXPERIMENTAL

CAB-AXL-ADC

Intervention Type BIOLOGICAL

Conditionally active biologic anti-AXL antibody drug conjugate

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

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

Group Type EXPERIMENTAL

CAB-AXL-ADC

Intervention Type BIOLOGICAL

Conditionally active biologic anti-AXL antibody drug conjugate

PD-1 inhibitor

Intervention Type BIOLOGICAL

PD-1 inhibitor

Interventions

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CAB-AXL-ADC

Conditionally active biologic anti-AXL antibody drug conjugate

Intervention Type BIOLOGICAL

PD-1 inhibitor

PD-1 inhibitor

Intervention Type BIOLOGICAL

Other Intervention Names

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BA3011

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioAtla, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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City of Hope - Duarte

Duarte, California, United States

Site Status

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

Irvine, California, United States

Site Status

California Research Institute

Los Angeles, California, United States

Site Status

USC Norris

Los Angeles, California, United States

Site Status

Cedars-Sinai

Los Angeles, California, United States

Site Status

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

San Diego, California, United States

Site Status

American Institute of Research

Whittier, California, United States

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Florida Cancer Specialists & Research Institute

Fleming Island, Florida, United States

Site Status

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialist

St. Petersburg, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Florida Cancer Specialists

West Palm Beach, Florida, United States

Site Status

Augusta University - Georgia Cancer Center

Augusta, Georgia, United States

Site Status

Baptist Health Systems

Lexington, Kentucky, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Norton Cancer Institute, Brownsboro Hospital Campus

Louisville, Kentucky, United States

Site Status

Hematology/Oncology Clinic

Baton Rouge, Louisiana, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

University of Michigan Comprehensive Cancer Center

Detroit, Michigan, United States

Site Status

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

Site Status

OptumCare Cancer Care

Las Vegas, Nevada, United States

Site Status

Roswell Park

Buffalo, New York, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States

Site Status

Gabrail Cancer Research Center

Canton, Ohio, United States

Site Status

The Lindner Research Center at the Christ Hospital

Cincinnati, Ohio, United States

Site Status

UPMC Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina- Hollings Cancer Center

Charleston, South Carolina, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status

MD Anderson

Houston, Texas, United States

Site Status

Henry Dunant Hospital Center

Athens, , Greece

Site Status

Metropolitan Hospital Perseus Healthcare Group SA

Piraeus, , Greece

Site Status

Bioclinic Thessaloniki

Thessaloniki, , Greece

Site Status

European Interbalkan Medical Center

Thessaloniki, , Greece

Site Status

ICON Cancer Centre

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Hong Kong United Oncology Centre

Kowloon, , Hong Kong

Site Status

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

Genoa, Liguria, Italy

Site Status

Hospital San Giuseppe Moscati

Avellino, , Italy

Site Status

European Institute of Oncology (IEO), IRCCS

Milan, , Italy

Site Status

Santa Maria delle Croci Hospital of Ravenna

Ravenna, , Italy

Site Status

Integrated University Hospital of Verona

Verona, , Italy

Site Status

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

Poznan, Greater Poland Voivodeship, Poland

Site Status

Institute of Genetics and Immunology GENIM

Lublin, Lublin Voivodeship, Poland

Site Status

Maria Sklodowska-Curie - National Research Institute of Oncology

Warsaw, Masovian Voivodeship, Poland

Site Status

Polish Mother's Memorial Hospital-Research Institute

Lodz, Łódź Voivodeship, Poland

Site Status

Specialistic Oncologic Hospital NU-MED

Tomaszów Mazowiecki, Łódź Voivodeship, Poland

Site Status

Hospital Universitario Virgen de Valme

Seville, Andalusia, Spain

Site Status

Hospital del Mar

Barcelona, Catalonia, Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status

Catalan Institute of Oncology, Hospital Duran i Reynals

Barcelona, Catalonia, Spain

Site Status

University Hospital 12 de Octubre

Madrid, Madrid, Spain

Site Status

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Site Status

Kaoshiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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United States Greece Hong Kong Italy Poland Spain Taiwan

Other Identifiers

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BA3011-002

Identifier Type: -

Identifier Source: org_study_id

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