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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04681131
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
BioAtla, Inc.

Study Description
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Brief Summary:
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Biological: CAB-AXL-ADC Biological: PD-1 inhibitor Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 17, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: BA3011

Biological: PD-1 inhibitor
PD-1 inhibitor


Outcome Measures
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Primary Outcome Measures :
  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 or Serious Adverse Events 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 Outcome Measures :
  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 (OR) [ 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681131


Contacts
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Contact: Ji Hwan Lee 858-286-7702 jlee@bioatla.com
Contact: Hazel Buncab 858-263-1598 hbuncab@bioatla.com

Locations
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Sponsors and Collaborators
BioAtla, Inc.
More Information
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Responsible Party: BioAtla, Inc.
ClinicalTrials.gov Identifier: NCT04681131    
Other Study ID Numbers: BA3011-002
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioAtla, Inc.:
Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents