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

September 22, 2025 updated by: BioAtla, Inc.

A Phase 2 Study of BA3011 Alone and in Combination With PD-1 Inhibitor in Adult Patients With Metastatic Non-small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on a PD-1/L-1 Inhibitor, EGFR, or ALK Inhibitor.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 115 26
        • Henry Dunant Hospital Center
      • Piraeus, Greece, 185 47
        • Metropolitan Hospital Perseus Healthcare Group SA
      • Thessaloniki, Greece, 546 22
        • Bioclinic Thessaloniki
      • Thessaloniki, Greece, 570 01
        • European Interbalkan Medical Center
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Icon Cancer Centre
      • Kowloon, Hong Kong
        • Hong Kong United Oncology Centre
  • Italy
      • Avellino, Italy, 83100
        • Hospital San Giuseppe Moscati
      • Milan, Italy, 20141
        • European Institute of Oncology (IEO), IRCCS
      • Ravenna, Italy, 48121
        • Santa Maria delle Croci Hospital of Ravenna
      • Verona, Italy, 37126
        • Integrated University Hospital of Verona
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • "IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-693
        • MED-Polonia, Sp. z o.o. (LLC)
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-609
        • Institute of Genetics and Immunology GENIM
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Maria Sklodowska-Curie - National Research Institute of Oncology
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-338
        • Polish Mother's Memorial Hospital-Research Institute
      • Tomaszów Mazowiecki, Łódź Voivodeship, Poland, 97-200
        • Specialistic Oncologic Hospital NU-MED
  • Spain
    • Andalusia
      • Seville, Andalusia, Spain, 41014
        • Hospital Universitario Virgen de Valme
    • Catalonia
      • Barcelona, Catalonia, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Catalonia, Spain, 08003
        • Hospital del Mar
      • Barcelona, Catalonia, Spain, 08908
        • Catalan Institute of Oncology, Hospital Duran i Reynals
    • Madrid
      • Madrid, Madrid, Spain, 28041
        • University Hospital 12 de Octubre
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaoshiung Chang Gung Memorial Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Tainan City, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope - Duarte
      • Irvine, California, United States, 92868
        • University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai
      • Los Angeles, California, United States, 90027
        • California Research Institute
      • Los Angeles, California, United States, 90033
        • USC Norris
      • San Diego, California, United States, 92093
        • University of California, San Diego (UCSD) - Moores Cancer Center
      • Whittier, California, United States, 90603
        • American Institute of Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Florida Cancer Specialists & Research Institute
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists & Research Institute
      • St. Petersburg, Florida, United States, 33705
        • Florida Cancer Specialist
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University - Georgia Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Systems
      • Louisville, Kentucky, United States, 40241
        • Norton Cancer Institute, Brownsboro Hospital Campus
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology/Oncology Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • University of Michigan Comprehensive Cancer Center
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89169
        • OptumCare Cancer Care
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park
      • New York, New York, United States, 10016
        • NYU Langone Health
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth Outpatient Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Research Center
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Research Center at The Christ Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Medical University of South Carolina- Hollings Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research
      • Houston, Texas, United States, 77030
        • MD Anderson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAB-AXL-ADC (BA3011)
CAB-AXL-ADC (BA3011) alone
Biological: CAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
Other Names:
  • BA3011
Experimental: CAB-AXL-ADC (BA3011)+PD-1 inhibitor
CAB-AXL-ADC (BA3011) with PD-1 inhibitor
Biological: CAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
Other Names:
  • BA3011
Biological: PD-1 inhibitor
PD-1 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed Objective Response Rate (ORR) per RECIST v1.1
Time Frame: Up to 24 months
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
Time Frame: Up to 24 months
Measured by frequency and severity of adverse events as assessed by CTCAE v4.03/v5
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DOR)
Time Frame: 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
Up to 24 months
Progression-free survival (PFS)
Time Frame: 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.
Up to 24 months
Disease control rate (DCR)
Time Frame: Up to 24 months
Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks.
Up to 24 months
Time to response (TTR)
Time Frame: Up to 24 months
Time from the first dose of investigational product until the first documentation of OR.
Up to 24 months
Overall survival (OS)
Time Frame: Up to 24 months
Time from the first dose of BA3021 treatment until death due to any cause.
Up to 24 months
Best overall response (BOR)
Time Frame: Up to 24 months
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Up to 24 months
Percent change from baseline in target lesion sum of diameters
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioAtla, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

July 9, 2025

Study Completion (Actual)

July 9, 2025

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA3011-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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