CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)
NCT ID: NCT03504488
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
132 participants
INTERVENTIONAL
2018-06-27
2024-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monotherapy - CAB-ROR2-ADC (BA3021) alone
BA3021 alone Q2W dosing regimen
CAB-ROR2-ADC
Conditionally active biologic anti-ROR2 antibody drug conjugate
Combination Therapy
CAB-ROR2-ADC (BA3021) with PD-1 inhibitor
CAB-ROR2-ADC
Conditionally active biologic anti-ROR2 antibody drug conjugate
PD-1 inhibitor
PD-1 inhibitor
Interventions
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CAB-ROR2-ADC
Conditionally active biologic anti-ROR2 antibody drug conjugate
PD-1 inhibitor
PD-1 inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have measurable disease.
* For the dose expansion phase: Patients with locally advanced unresectable or metastatic, 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 Criteria
* Patients must not have known non-controlled CNS metastasis.
* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas 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 BA3021 administration.
* Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
* 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.
18 Years
ALL
No
Sponsors
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BioAtla, Inc.
INDUSTRY
Responsible Party
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Locations
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LinKou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
University of Arizona Cancer Center
Tucson, Arizona, United States
City of Hope - Duarte
Duarte, California, United States
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States
California Research Institute
Los Angeles, California, United States
USC Norris
Los Angeles, California, United States
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California San Francisco
San Francisco, California, United States
American Institute of Research
Whittier, California, United States
University of Colorado
Aurora, Colorado, United States
Sarah Cannon Research Institute at Health One
Denver, Colorado, United States
Florida Cancer Specialists & Research Institute
Fleming Island, Florida, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
Memorial Cancer Institute (MCI)
Hollywood, Florida, United States
Florida Cancer Specialist - North
St. Petersburg, Florida, United States
Memorial Sloan-Kettering Cancer Center
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Augusta University - Georgia Cancer Center
Augusta, Georgia, United States
Baptist Health Systems
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Norton Cancer Institute, Brownsboro Hospital Campus
Louisville, Kentucky, United States
Hematology/Oncology Clinic
Baton Rouge, Louisiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Comprehensive Cancer Care of Nevada
Las Vegas, Nevada, United States
OptumCare Cancer Care
Las Vegas, Nevada, United States
Roswell Park
Buffalo, New York, United States
NYU Langone Health
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina- Hollings Cancer Center
Charleston, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit
Athens, , Greece
Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department
Piraeus, , Greece
Bioclinic Thessaloniki, Οncology Department
Thessaloniki, , Greece
European Interbalkan Medical Center, Οncology Department
Thessaloniki, , Greece
Prince of Wales Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
MED-Polonia, Sp. z o.o. (LLC)
Poznan, Greater Poland Voivodeship, Poland
Institute of Genetics and Immunology GENIM LCC in Lublin
Lublin, Lublin Voivodeship, Poland
Malgorzata Kozlik
Warsaw, Masovian Voivodeship, Poland
Polish Mother's Memorial Hospital-Research Institute
Lodz, Łódź Voivodeship, Poland
Beata Głogowska
Tomaszów Mazowiecki, Łódź Voivodeship, Poland
University Hospital Nuestra Senora de Valme
Seville, Andalusia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Anna Ramos Luna
Barcelona, Catalonia, Spain
University Clinic of Navarra - Madrid
Madrid, , Spain
University Hospital 12 de Octubre
Madrid, , Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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BA3021-001
Identifier Type: -
Identifier Source: org_study_id
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