CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

Last updated: January 13, 2025
Sponsor: BioAtla, Inc.
Overall Status: Completed

Phase

1/2

Condition

Melanoma

Head And Neck Cancer

Breast Cancer

Treatment

CAB-ROR2-ADC

PD-1 inhibitor

Clinical Study ID

NCT03504488
BA3021-001
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed locally advancedunresectable or metastatic solid tumor and have failed all available standard ofcare (SoC) therapy and for whom no curative therapy is available or who are noteligible, intolerant to or refuse standard therapy.

  • Patients must have measurable disease.

  • For the dose expansion phase: Patients with locally advanced unresectable ormetastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC)and soft tissue sarcoma (STS)

  • 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

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 aswellas known or suspected allergy or intolerance to any agent given during thisstudy.

  • Patients must not have had major surgery within 4 weeks before first BA3021administration.

  • 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: 132
Treatment Group(s): 2
Primary Treatment: CAB-ROR2-ADC
Phase: 1/2
Study Start date:
June 27, 2018
Estimated Completion Date:
December 30, 2024

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 BA3021, a conditionally active biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2-ADC) BA3021 in patients with advanced solid tumors.

This study will consist of a dose escalation phase and a dose expansion phase with BA3021 in Phase 1. Phase 2 will study BA3021 alone or in combination with a PD-1 inhibitor.

Connect with a study center

  • Jeanette Natschke

    Berlin, 13359
    Germany

    Site Not Available

  • Norman Golchert

    Berlin, 13125
    Germany

    Site Not Available

  • Thea Resch

    Essen, 45136
    Germany

    Site Not Available

  • Asklepios Clinical Center Harburg

    Hamburg, 21075
    Germany

    Site Not Available

  • "Sotiria" Chest Diseases Hospital of Athens, 3rd Department of Internal Medicine of University of Athens, Oncology Unit

    Athens, 11527
    Greece

    Site Not Available

  • HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit

    Athens, 11526
    Greece

    Site Not Available

  • Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department

    Piraeus, 18547
    Greece

    Site Not Available

  • Bioclinic Thessaloniki, Οncology Department

    Thessaloniki, 54622
    Greece

    Site Not Available

  • European Interbalkan Medical Center, Οncology Department

    Thessaloniki, 57001
    Greece

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Santa Maria delle Croci Hospital of Ravenna

    Ravenna, Emilia-Romagna 48121
    Italy

    Site Not Available

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

    Genoa, Liguria 16132
    Italy

    Site Not Available

  • Polish Mother's Memorial Hospital-Research Institute

    Lodz, Lodzkie 93-338
    Poland

    Site Not Available

  • Beata Głogowska

    Tomaszów Mazowiecki, Lodzkie 97-200
    Poland

    Site Not Available

  • Institute of Genetics and Immunology GENIM LCC in Lublin

    Lublin, Lubelskie 20-609
    Poland

    Site Not Available

  • Malgorzata Kozlik

    Warsaw, Mazowieckie 08-781
    Poland

    Site Not Available

  • MED-Polonia, Sp. z o.o. (LLC)

    Poznan, Wielkopolskie 60-693
    Poland

    Site Not Available

  • University Hospital Nuestra Senora de Valme

    Sevilla, Andalusia 41014
    Spain

    Site Not Available

  • Anna Ramos Luna

    Barcelona, Catalonia 08908
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia 08041
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, Catalonia 089003
    Spain

    Site Not Available

  • University Clinic of Navarra - Madrid

    Madrid, 28027
    Spain

    Site Not Available

  • University Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City,
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei City,
    Taiwan

    Site Not Available

  • LinKou Chang Gung Memorial Hospital

    Taoyuan City,
    Taiwan

    Site Not Available

  • University of Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • City of Hope - Duarte

    Duarte, California 91010
    United States

    Site Not Available

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

    La Jolla, California 92093
    United States

    Site Not Available

  • California Research Institute

    Los Angeles, California 90027
    United States

    Site Not Available

  • USC Norris

    Los Angeles, California 90033
    United States

    Site Not Available

  • UC Irvine Medical Center - Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • American Institute of Research

    Whittier, California 90603
    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

  • Florida Cancer Specialists & Research Institute

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida 33916
    United States

    Site Not Available

  • Memorial Cancer Institute (MCI)

    Hollywood, Florida 33028
    United States

    Site Not Available

  • Florida Cancer Specialist - North

    Saint Petersburg, Florida 34474
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Florida Cancer Specialists

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Augusta University - Georgia Cancer Center

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Baptist Health Systems

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Norton Cancer Institute, Brownsboro Hospital Campus

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Hematology/Oncology Clinic

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Comprehensive Cancer Care of Nevada

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • OptumCare Cancer Care

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • Roswell Park

    Buffalo, New York 14263
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina 28374
    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

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Medical University of South Carolina- Hollings Cancer Center

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • 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

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.