Breast Cancer Clinical Trial

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

Summary

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.
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 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 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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

420

Study ID:

NCT03504488

Recruitment Status:

Recruiting

Sponsor:

BioAtla, Inc.

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There are 58 Locations for this study

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University of Arizona Cancer Center
Tucson Arizona, 85724, United States
City of Hope - Duarte
Duarte California, 91010, United States More Info
Edwin Smura
Contact
[email protected]
Mykola Onyshchenko, MD
Principal Investigator
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla California, 92093, United States More Info
Miguel Alvendia
Contact
[email protected]
Lyudmila Bazhenova
Principal Investigator
California Research Institute
Los Angeles California, 90027, United States More Info
Clare Gregorio
Contact
[email protected]
Luiza Mnatsakanyan
Contact
[email protected]
Ghassan Al-Jazayrly, MD
Principal Investigator
USC Norris
Los Angeles California, 90033, United States More Info
Jessica Levano
Contact
[email protected]
Jacob Thomas, MD
Principal Investigator
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange California, 92868, United States More Info
Samantha Noble
Contact
[email protected]
Misako Nagasaka
Principal Investigator
University of California San Francisco
San Francisco California, 94158, United States More Info
Markee Micu
Contact
[email protected]
Katy Tsai, MD
Principal Investigator
American Institute of Research
Whittier California, 90603, United States
University of Colorado
Aurora Colorado, 80045, United States More Info
Teresa Medina, MD
Contact
303-266-3764
[email protected]
Rebeca Elizondo
Contact
720-848-4288
[email protected]
David Ross Camidge, MD
Principal Investigator
Sarah Cannon Research Institute at Health One
Denver Colorado, 80218, United States More Info
Gerald Falchook, MD
Contact
720-754-2610
[email protected]
Susan Hall
Contact
720-754-2610
[email protected]
Gerald Falchook, MD
Principal Investigator
Florida Cancer Specialists & Research Institute
Fleming Island Florida, 32003, United States More Info
Sheila Gagne
Contact
904-269-6526
[email protected]
Augusto Villegas, MD
Principal Investigator
Florida Cancer Specialists & Research Institute
Fort Myers Florida, 33916, United States More Info
Donna-May Bernard
Contact
239-274-9930
[email protected]
Ivor Percent, MD
Principal Investigator
Memorial Cancer Institute (MCI)
Hollywood Florida, 33028, United States
Florida Cancer Specialist - North
Saint Petersburg Florida, 34474, United States More Info
Lyrae Layne
Contact
[email protected]
Vipul Patel, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
Tampa Florida, 33612, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Jacqueline Andrews
Contact
813-745-3553
[email protected]
Mihaela Druta, MD
Principal Investigator
Andres Saltos, MD
Principal Investigator
Florida Cancer Specialists
West Palm Beach Florida, 33401, United States More Info
De'Dra Kelly
Contact
561-366-4100
[email protected]
Eric Harris, MD
Principal Investigator
Augusta University - Georgia Cancer Center
Augusta Georgia, 30912, United States More Info
Kelly Jenkins
Contact
[email protected]
Girindra Raval
Principal Investigator
Baptist Health Systems
Lexington Kentucky, 40503, United States
University of Kentucky
Lexington Kentucky, 40536, United States More Info
Sarah Howard
Contact
[email protected]
Susanne Arnold, MD
Principal Investigator
Norton Cancer Institute, Brownsboro Hospital Campus
Louisville Kentucky, 40241, United States More Info
Pamela Adkisson
Contact
[email protected]
Jaspreet Grewal, MD
Principal Investigator
Hematology/Oncology Clinic
Baton Rouge Louisiana, 70809, United States More Info
Aimee Alumbaugh
Contact
225-761-3951
[email protected]
Michael Castine, MD
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Comprehensive Cancer Care of Nevada
Las Vegas Nevada, 89169, United States
OptumCare Cancer Care
Las Vegas Nevada, 89169, United States
Roswell Park
Buffalo New York, 14263, United States More Info
Julianne Hergenroder
Contact
800-767-9355
[email protected]
Edwin Yau, MD
Principal Investigator
NYU Langone Health
New York New York, 10016, United States More Info
Zaykov Viktor
Contact
[email protected]
Elaine Shum, MD
Principal Investigator
Columbia University Medical Center
New York New York, 10032, United States
FirstHealth Outpatient Cancer Center
Pinehurst North Carolina, 28374, United States More Info
Julie Williams
Contact
910-715-1922
[email protected]
Charles Kuzma, MD
Principal Investigator
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
The Christ Hospital
Cincinnati Ohio, 45219, United States More Info
Abby Reed
Contact
[email protected]
Monica Treta
Contact
[email protected]
Alexander Starodub, MD
Principal Investigator
Oregon Health & Science University
Portland Oregon, 97239, United States
UPMC Cancer Center
Pittsburgh Pennsylvania, 15232, United States More Info
Liza Villaruz, MD
Principal Investigator
Medical University of South Carolina- Hollings Cancer Center
Charleston South Carolina, 29407, United States More Info
Alexandra Leitner
Contact
[email protected]
Mariam Alexander, MD
Principal Investigator
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Howard Burris, MD
Contact
[email protected]
Leigh Bumpous
Contact
615-748-0767
[email protected]
Howard Burris, MD
Principal Investigator
Mary Crowley Cancer Research
Dallas Texas, 75230, United States More Info
Mahogany Wadford
Contact
[email protected]
Reva Schneider, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Yoko Yamamura
Contact
713-792-9869
[email protected]
Siqing Fu, MD
Principal Investigator
University of Utah - Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States More Info
Mia Klonsky
Contact
801-581-5260
[email protected]
Ashley Lewary
Contact
[email protected]
Joanne Jeter, MD
Principal Investigator
Norman Golchert
Berlin , 13125, Germany More Info
Norman PL Golchert
Contact
[email protected]
Christian Grohé
Principal Investigator
Jeanette Natschke
Berlin , 13359, Germany More Info
Jeanette PL Natschke
Contact
[email protected]
Bernd Schmidt
Principal Investigator
Thea Resch
Essen , 45136, Germany More Info
Thea Resch
Contact
[email protected]
Daniel Christoph
Principal Investigator
Asklepios Clinical Center Harburg
Hamburg , 21075, Germany More Info
Nicole Hundrieser
Contact
[email protected]
Claas Wesseler
Principal Investigator
HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit
Athens , 11526, Greece More Info
Dimitrios Tzanos
Contact
[email protected]
Ioannis Mountzios
Principal Investigator
"Sotiria" Chest Diseases Hospital of Athens, 3rd Department of Internal Medicine of University of Athens, Oncology Unit
Athens , 11527, Greece More Info
Roza Mariatou
Contact
[email protected]
Konstantinos Syrigos
Principal Investigator
Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department
Piraeus , 18547, Greece More Info
Kanella-Maria Gkiati
Contact
[email protected]
Eleni Linardou
Principal Investigator
Bioclinic Thessaloniki, Οncology Department
Thessaloniki , 54622, Greece More Info
Panagiota Papadopoulou
Contact
[email protected]
Ioannis Boukovinas
Principal Investigator
European Interbalkan Medical Center, Οncology Department
Thessaloniki , 57001, Greece More Info
Eleni Papadopoulou
Contact
[email protected]
Sofia Baka
Principal Investigator
Prince of Wales Hospital
Hong Kong , , Hong Kong More Info
Herbert Loong, MD
Principal Investigator
Queen Mary Hospital
Hong Kong , , Hong Kong More Info
Thomas Yau, MD
Principal Investigator
Santa Maria delle Croci Hospital of Ravenna
Ravenna Emilia-Romagna, 48121, Italy More Info
Michela Spreafico
Contact
[email protected]
Manolo D'Arcangelo
Principal Investigator
"IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."
Genoa Liguria, 16132, Italy More Info
Linda Zinoli
Contact
[email protected]
Carlo Genova
Principal Investigator
Polish Mother's Memorial Hospital-Research Institute
Lodz Lodzkie, 93-33, Poland More Info
Marta Grubiak
Contact
[email protected]
Ewa Kalinka
Principal Investigator
Beata Głogowska
Tomaszów Mazowiecki Lodzkie, 97-20, Poland More Info
Beata Głogowska
Contact
[email protected]
Ewa Chmielowska
Principal Investigator
Institute of Genetics and Immunology GENIM LCC in Lublin
Lublin Lubelskie, 20-60, Poland More Info
Katarzyna Reszka
Contact
[email protected]
Izabela Chmielewska
Principal Investigator
Malgorzata Kozlik
Warsaw Mazowieckie, 08-78, Poland More Info
Malgorzata Kozlik
Contact
[email protected]
Dariusz Kowalski
Principal Investigator
MED-Polonia, Sp. z o.o. (LLC)
Poznan Wielkopolskie, 60-69, Poland More Info
Katarzyna Ewert
Contact
[email protected]
Rodryg Ramlau
Principal Investigator
University Hospital Nuestra Senora de Valme
Sevilla Andalusia, 41014, Spain More Info
Javier Diaz Álvarez
Contact
[email protected]
Jose Fuentes Pradera
Principal Investigator
Hospital de la Santa Creu i Sant Pau
Barcelona Catalonia, 08041, Spain More Info
Laia I Lavernia Rossell
Contact
[email protected]
Ivana Sullivan
Principal Investigator
Hospital del Mar
Barcelona Catalonia, 08900, Spain More Info
Rosa I Lopez Parellada
Contact
[email protected]
Alvaro Taus
Principal Investigator
Anna Ramos Luna
Barcelona Catalonia, 08908, Spain More Info
Anna I Ramos Luna
Contact
[email protected]
Ernest Nadal
Principal Investigator
University Clinic of Navarra - Madrid
Madrid , 28027, Spain More Info
Sara Diaz Sanchez
Contact
[email protected]
Gonzalo Hinojal
Principal Investigator
University Hospital 12 de Octubre
Madrid , 28041, Spain More Info
Maripaz Soriano
Contact
[email protected]
Jon Zugazagoitia Fraile
Principal Investigator
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City , , Taiwan More Info
Chien-Ya Lin
Contact
[email protected]
Chin-Chou Wang, MD
Principal Investigator
National Cheng Kung University Hospital
Tainan , , Taiwan More Info
Shih-Han Chiu
Contact
[email protected]
Wu-Chou Su, MD
Principal Investigator
National Taiwan University Hospital
Taipei City , , Taiwan More Info
Ying-Chun Liu
Contact
[email protected]
Jin-Yuan Shih, MD
Principal Investigator
LinKou Chang Gung Memorial Hospital
Taoyuan City , , Taiwan More Info
Li-Ying Ou
Contact
[email protected]
Wen-Cheng Chang, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

420

Study ID:

NCT03504488

Recruitment Status:

Recruiting

Sponsor:


BioAtla, Inc.

How clear is this clinincal trial information?

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