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

View Full Description

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.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 33 Locations for this study

See Locations Near You

University of Arizona Cancer Center
Tucson Arizona, 85724, United States More Info
Pavani Chalasani, MD
Contact
520-626-0191
[email protected]
Pavani Chalasani, MD
Principal Investigator
City of Hope - Duarte
Duarte California, 91010, United States More Info
Edwin Smura
Contact
[email protected]
Ranjan Pathak, MD
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
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 More Info
Kirsten Bettino
Contact
[email protected]
Ramiz Ibrahim
Contact
[email protected]
Richy Agajanian, MD
Principal Investigator
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]
Teresa Medina, 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 More Info
Tamara Quintana
Contact
[email protected]
Sophia Ward-Evans
Contact
[email protected]
Luis Raez, MD
Principal Investigator
Florida Cancer Specialist - North
Saint Petersburg Florida, 34474, United States More Info
Lyrae Layne
Contact
[email protected]
Vipul Patel, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Samantha Wheeler
Contact
646-888-1385
[email protected]
Bella Pinque
Contact
646-888-1394
[email protected]
Bill Tap
Principal Investigator
Paul Chapman
Principal Investigator
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
Baptist Health Systems
Lexington Kentucky, 40503, United States More Info
Jennifer Buntain
Contact
[email protected]
Firas Badin, MD
Principal Investigator
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 More Info
Stefania Molinaro
Contact
[email protected]
Julia Rotow, MD
Principal Investigator
Comprehensive Cancer Care of Nevada
Las Vegas Nevada, 89169, United States More Info
Karishma Gupta
Contact
702-862-1114
[email protected]
Ramalingam Ratnasabapathy, MD
Principal Investigator
OptumCare Cancer Care
Las Vegas Nevada, 89169, United States More Info
Valerie Littlefield
Contact
702-384-0013
[email protected]
John Ellerton, MD
Principal Investigator
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 More Info
Swathi Balaji
Contact
212-304-5548
[email protected]
Morgan Bryant
Contact
212-342-9004
[email protected]
Matthew Ingham, MD
Principal Investigator
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 More Info
Jeffrey Kettler
Contact
336-716-4760
[email protected]
Nikolas Soetermans
Contact
336-713-5865
[email protected]
Lowell Hart, MD
Principal Investigator
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 More Info
Kyaw Thein, MD
Contact
[email protected]
Andrzej Stadnik
Contact
503-494-2636
[email protected]
Kyaw Thein, MD
Principal Investigator
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
Tennessee Oncology
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]
James Strauss, 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
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
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?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.