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Completed

NCT Number: NCT04681131

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

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

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henry Dunant Hospital Center, Athens, Greece

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CAB-AXL-ADC

Biological

Conditionally active biologic anti-AXL antibody drug conjugate

Other names: BA3011

PD-1 inhibitor

Biological

PD-1 inhibitor

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. Time to response (TTR)

    Time frame: Up to 24 months

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

  6. Overall survival (OS)

    Time frame: Up to 24 months

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

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

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

BioAtla, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2020
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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