CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients with Sarcoma

Last updated: January 13, 2025
Sponsor: BioAtla, Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Osteosarcoma

Melanoma

Brain Cancer

Treatment

PD-1 inhibitor

CAB-AXL-ADC

Clinical Study ID

NCT03425279
BA3011-001
  • Ages > 12
  • All Genders

Study Summary

The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have measurable disease.

  • Age ≥ 12 years (Phase 2)

  • 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

Exclusion Criteria:

  • Patients must not have clinically significant cardiac disease.

  • Patients must not have known non-controlled CNS metastasis.

  • Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy aswell as known or suspected allergy or intolerance to any agent given during thisstudy.

  • Patients must not have had major surgery within 4 weeks before first BA3011administration.

  • Patients must not have had prior therapy with a conjugated or unconjugatedauristatin derivative/vinca-binding site targeting payload.

  • Patients must not have known human immunodeficiency virus (HIV) infection, activehepatitis B and/or hepatitis C.

  • Patients must not be women who are pregnant or breast feeding.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: PD-1 inhibitor
Phase: 1/2
Study Start date:
February 15, 2018
Estimated Completion Date:
January 31, 2025

Study Description

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of mecbotamab vedotin (BA3011), a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors.

Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024).

Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).

Connect with a study center

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital

    Taoyuan,
    Taiwan

    Site Not Available

  • The University of Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Precision NextGen Oncology

    Los Angeles, California 90212
    United States

    Site Not Available

  • Tower Hematology Oncology Medical Group

    Los Angeles, California 90048
    United States

    Site Not Available

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • UCSF Medical Center - Cancer Immunotherapy Clinic (CIC)

    San Francisco, California 94158
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Sarah Cannon Research Institute at Health One

    Denver, Colorado 80218
    United States

    Site Not Available

  • Children's Research Institute

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Children's Research Institute

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Norton Cancer Institute

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Washington University School of Medicine - Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Comprehensive Cancer Center of Nevada

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering

    New York, New York 10065
    United States

    Site Not Available

  • Duke Cancer Institute

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Abramson Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania 19106
    United States

    Site Not Available

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Site Not Available

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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