Clincosm LogoSign in Get a demo

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

Sponsor
BioAtla, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04681131
Collaborator
(none)
240
Enrollment
35
Locations
2
Arms
20.5
Anticipated Duration (Months)
6.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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 :
Mar 17, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Confirmed Objective Response Rate (ORR) per RECIST v1.1 [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 [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) [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) [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) [Up to 24 months]

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

    4. Disease control rate (DCR) [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) [Up to 24 months]

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

    6. Overall survival (OS) [Up to 24 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 City of Hope - Duarte Duarte California United States 91010
    2 California Research Institute Los Angeles California United States 90027
    3 USC Norris Los Angeles California United States 90033
    4 Cedars-Sinai Los Angeles California United States 90048
    5 American Institute of Research Whittier California United States 90603
    6 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045
    7 Florida Cancer Specialists & Research Institute Fleming Island Florida United States 32003
    8 Florida Cancer Specialists & Research Institute Fort Myers Florida United States 33916
    9 Florida Cancer Specialist Saint Petersburg Florida United States 33705
    10 Florida Cancer Specialists West Palm Beach Florida United States 33401
    11 Baptist Health Systems Lexington Kentucky United States 40503
    12 University of Kentucky Lexington Kentucky United States 40536
    13 Norton Cancer Institute, Brownsboro Hospital Campus Louisville Kentucky United States 40241
    14 Hematology/Oncology Clinic Baton Rouge Louisiana United States 70809
    15 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    16 University of Michigan Comprehensive Cancer Center Detroit Michigan United States 48202
    17 Comprehensive Cancer Centers of Nevada Henderson Nevada United States 89014
    18 OptumCare Cancer Care Las Vegas Nevada United States 89169
    19 Roswell Park Buffalo New York United States 14263
    20 NYU Langone Health New York New York United States 10016
    21 FirstHealth Outpatient Cancer Center Pinehurst North Carolina United States 28374
    22 Gabrail Cancer Research Center Canton Ohio United States 44718
    23 The Lindner Research Center at the Christ Hospital Cincinnati Ohio United States 45219
    24 UPMC Cancer Center Pittsburgh Pennsylvania United States 15232
    25 Medical University of South Carolina- Hollings Cancer Center Charleston South Carolina United States 29407
    26 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    27 Mary Crowley Cancer Research Dallas Texas United States 75230
    28 MD Anderson Houston Texas United States 77030
    29 ICON Cancer Centre Hong Kong Hong Kong
    30 Queen Mary Hospital Hong Kong Hong Kong
    31 Hong Kong United Oncology Centre Kowloon Hong Kong
    32 Kaoshiung Chang Gung Memorial Hospital Kaohsiung Taiwan
    33 Taichung Veterans General Hospital Taichung Taiwan
    34 National Taiwan University Hospital Taipei Taiwan
    35 Taipei Veterans General Hospital Taipei Taiwan

    Sponsors and Collaborators

    • BioAtla, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BioAtla, Inc.
    ClinicalTrials.gov Identifier:
    NCT04681131
    Other Study ID Numbers:
    • BA3011-002
    First Posted:
    Dec 23, 2020
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Immune Checkpoint Inhibitors

    Study Results

    No Results Posted as of Jul 13, 2022