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Non-Small-Cell Lung CancerPhase 2NCT04681131

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

A Phase 2 study testing CAB-AXL-ADC and PD-1 inhibitor in people with Non-Small-Cell Lung Cancer, run by BioAtla, Inc. at 60 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small-Cell Lung Cancer
What is being tested?
CAB-AXL-ADC and PD-1 inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
60 sitesin 7 countries
Study dates
17 Mar 2021to 9 Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

60 sites in 7 countries.

60 sites in 7 countries

United States32 sites

  • Augusta University - Georgia Cancer Center

    Augusta, Georgia, 30912

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Hematology/Oncology Clinic

    Baton Rouge, Louisiana, 70809

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park

    Buffalo, New York, 14263

  • Gabrail Cancer Research Center

    Canton, Ohio, 44718

  • Medical University of South Carolina- Hollings Cancer Center

    Charleston, South Carolina, 29407

  • The Lindner Research Center at the Christ Hospital

    Cincinnati, Ohio, 45219

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • University of Michigan Comprehensive Cancer Center

    Detroit, Michigan, 48202

  • City of Hope - Duarte

    Duarte, California, 91010

  • Florida Cancer Specialists & Research Institute

    Fleming Island, Florida, 32003

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida, 33916

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89014

  • MD Anderson

    Houston, Texas, 77030

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

    Irvine, California, 92868

  • OptumCare Cancer Care

    Las Vegas, Nevada, 89169

  • Baptist Health Systems

    Lexington, Kentucky, 40503

  • University of Kentucky

    Lexington, Kentucky, 40536

  • California Research Institute

    Los Angeles, California, 90027

  • USC Norris

    Los Angeles, California, 90033

  • Cedars-Sinai

    Los Angeles, California, 90048

  • Norton Cancer Institute, Brownsboro Hospital Campus

    Louisville, Kentucky, 40241

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • NYU Langone Health

    New York, New York, 10016

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232

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

    San Diego, California, 92093

  • Florida Cancer Specialist

    St. Petersburg, Florida, 33705

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • American Institute of Research

    Whittier, California, 90603

Other trials in United States

Spain6 sites

  • Hospital del Mar

    Barcelona, Catalonia, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Catalan Institute of Oncology, Hospital Duran i Reynals

    Barcelona, Catalonia, 08908

  • University Hospital 12 de Octubre

    Madrid, Madrid, 28041

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen de Valme

    Seville, Andalusia, 41014

Other trials in Spain

Italy5 sites

  • Hospital San Giuseppe Moscati

    Avellino, 83100

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

    Genoa, Liguria, 16132

  • European Institute of Oncology (IEO), IRCCS

    Milan, 20141

  • Santa Maria delle Croci Hospital of Ravenna

    Ravenna, 48121

  • Integrated University Hospital of Verona

    Verona, 37126

Other trials in Italy

Poland5 sites

  • Polish Mother's Memorial Hospital-Research Institute

    Lodz, Łódź Voivodeship, 93-338

  • Institute of Genetics and Immunology GENIM

    Lublin, Lublin Voivodeship, 20-609

  • MED-Polonia, Sp. z o.o. (LLC)

    Poznan, Greater Poland Voivodeship, 60-693

  • Specialistic Oncologic Hospital NU-MED

    Tomaszów Mazowiecki, Łódź Voivodeship, 97-200

  • Maria Sklodowska-Curie - National Research Institute of Oncology

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Taiwan5 sites

  • Kaoshiung Chang Gung Memorial Hospital

    Kaohsiung City

  • Taichung Veterans General Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

Other trials in Taiwan

Greece4 sites

  • Henry Dunant Hospital Center

    Athens, 115 26

  • Metropolitan Hospital Perseus Healthcare Group SA

    Piraeus, 185 47

  • Bioclinic Thessaloniki

    Thessaloniki, 546 22

  • European Interbalkan Medical Center

    Thessaloniki, 570 01

Other trials in Greece

Hong Kong3 sites

  • ICON Cancer Centre

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • Hong Kong United Oncology Centre

    Kowloon

Other trials in Hong Kong

About this study

Official title: 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

Read the 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).

Being tested
CAB-AXL-ADC, PD-1 inhibitor
Keywords
Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAB-AXL-ADCBiological

    Also called BA3011

    Conditionally active biologic anti-AXL antibody drug conjugate

  • PD-1 inhibitorBiological

    PD-1 inhibitor

Study groups in NCT04681131
Study groupRoleWhat they receive
CAB-AXL-ADC (BA3011)ExperimentalCAB-AXL-ADC (BA3011) alone
Receives: Biological: CAB-AXL-ADC
CAB-AXL-ADC (BA3011)+PD-1 inhibitorExperimentalCAB-AXL-ADC (BA3011) with PD-1 inhibitor
Receives: Biological: CAB-AXL-ADC; Biological: PD-1 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Up to 24 months

  2. 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

    Measured: Up to 24 months

Secondary outcomes (7)

  1. Duration of response (DOR)

    Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first

    Measured: Up to 24 months

  2. Progression-free survival (PFS)

    Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 24 months

  3. Best overall response (BOR)

    All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy

    Measured: Up to 24 months

  4. Disease control rate (DCR)

    Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks.

    Measured: Up to 24 months

  5. Time to response (TTR)

    Time from the first dose of investigational product until the first documentation of OR.

    Measured: Up to 24 months

  6. Overall survival (OS)

    Time from the first dose of BA3021 treatment until death due to any cause.

    Measured: Up to 24 months

  7. Percent change from baseline in target lesion sum of diameters

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start17 Mar 2021
  3. Primary completion9 Jul 2025
  4. Study completion9 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04681131
Sponsor's protocol ID
BA3011-002
Status last verified
Sep 2025
First submitted
8 Dec 2020
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CAB-AXL-ADC and PD-1 inhibitor in people with Non-Small-Cell Lung Cancer, run by BioAtla, Inc. at 60 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Spain, Italy, Poland, Taiwan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Objective Response Rate (ORR) per RECIST v1.1 (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04681131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

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