Melanoma Clinical Trial

Phase 2 CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma

Summary

The objective of this study is to assess safety and efficacy of CAB-AXL-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 BA3011, a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors in Phase 1 and BA3011 alone and in combination with a PD-1 inhibitor in Phase 2.

Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (still enrolling ACC patients only).

Phase 2 is targeted to begin in Q3 2020 and will include both adult and adolescents age 12 and over.

View Eligibility Criteria

Eligibility Criteria

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 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 BA3011 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:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT03425279

Recruitment Status:

Recruiting

Sponsor:

BioAtla, Inc.

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There are 29 Locations for this study

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The University of Arizona Cancer Center
Tucson Arizona, 85724, United States More Info
Janet Huynh
Contact
520-694-1231
[email protected]
Megan Hodges
Contact
520-694-9058
[email protected]
Pavani Chalasani, MD
Principal Investigator
Children's Hospital Los Angeles
Los Angeles California, 90027, United States More Info
Abrahm Levi
Contact
323-361-6686
[email protected]
Leo Mascarenhas, MD
Principal Investigator
USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Cristina Lee
Contact
323-865-0455
[email protected]
Jacob Thomas, MD
Principal Investigator
Tower Hematology Oncology Medical Group
Los Angeles California, 90048, United States More Info
Roland Menendez
Contact
310-231-2184
[email protected]
Linda Ford, PA-C
Contact
310-285-7268
[email protected]
Omid Hamid, MD
Principal Investigator
UCSF Medical Center - Cancer Immunotherapy Clinic (CIC)
San Francisco California, 94158, United States More Info
Lea Daran
Contact
[email protected]
Brian Schulte, MD
Principal Investigator
University of Colorado
Aurora Colorado, 80045, United States More Info
Haley Stewart
Contact
[email protected]
Heather McCoy
Contact
[email protected]
Breelyn Wilky, MD
Principal Investigator
Sarah Cannon Research Institute at Health One
Denver Colorado, 80218, United States More Info
Susan Hall
Contact
720-754-2659
[email protected]
Gerald Falchook, MD
Principal Investigator
Children's Research Institute
Washington District of Columbia, 20010, United States More Info
AeRang Kim, MD, PhD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Milijana Ugrenovic-Petrovic
Contact
[email protected]
Soha Riad
Contact
[email protected]fitt.org
Mihaela Druta, MD
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Hannah Knott
Contact
[email protected]
Seth Pollack, MD
Principal Investigator
Norton Cancer Institute
Louisville Kentucky, 40202, United States More Info
Kylee Fleig
Contact
502-629-3681
[email protected]
Jaspreet Grewal, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Kristina Goodwin
Contact
[email protected]
Gregory Cote
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Claire Kowalczyk
Contact
617-582-8349
[email protected]
Suzanne George, MD
Principal Investigator
Comprehensive Cancer Center of Nevada
Las Vegas Nevada, 89169, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Ajay Gupta
Principal Investigator
Columbia University
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
Memorial Sloan Kettering
New York New York, 10065, United States More Info
Taylor Jordan
Contact
646-888-1392
[email protected]
Bill M. Tap, MD
Principal Investigator
Duke Cancer Institute
Durham North Carolina, 27710, United States More Info
Ethan Miller
Contact
[email protected]
Richard Riedel, MD
Principal Investigator
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States More Info
Ashley C Fansler, RN
Contact
336-713-3539
[email protected]
Paul Savage, MD
Principal Investigator
University Hospitals Seidman Cancer Center
Cleveland Ohio, 44106, United States More Info
Kyle Logue
Contact
216-286-1090
[email protected]
Ankit Mangla, MD
Principal Investigator
Nationwide Children's Hospital
Columbus Ohio, 43205, United States More Info
Karina Woodling
Contact
[email protected]
Bhuvana Setty, MD
Principal Investigator
Oregon Health & Science University
Portland Oregon, 97239, United States More Info
Elizabeth Newby
Contact
[email protected]
Brett Rodgers
Contact
[email protected]
Lara Davis, MD
Principal Investigator
The Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States More Info
Cindy Rodriguez
Contact
[email protected]
Theodore Laetsch, MD
Principal Investigator
Tennessee Oncology
Nashville Tennessee, 37203, United States More Info
Scott Miller
Contact
[email protected]
Howard Burris, MD
Principal Investigator
Vanderbilt Ingram Cancer Center
Nashville Tennessee, 37232, United States More Info
Kathy Taylor
Contact
615-875-0060
[email protected]
Elizabeth Davis, MD
Principal Investigator
Mary Crowley Cancer Research
Dallas Texas, 75230, United States More Info
Jessica Bondurant
Contact
972-566-3065
[email protected]
James Strauss, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Jordi Rodon
Contact
713-792-8927
[email protected]
Denisse T Velazquez
Contact
832-728-5851
[email protected]
Jordi Rodon, MD
Principal Investigator
University of Utah - Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States More Info
Susan Sharry
Contact
801-585-3453
[email protected]
Ashley Leary
Contact
801-213-8429
[email protected]
Anna Chalmers, MD
Principal Investigator
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States More Info
Stephanie Wright
Contact
[email protected]
Elizabeth Loggers, MD
Principal Investigator
Prince of Wales Hospital
Hong Kong , , Hong Kong More Info
Ka Wah Chu
Contact
[email protected]
Herbert Loong, MD
Principal Investigator
Queen Mary Hospital
Hong Kong , , Hong Kong More Info
Winnie Chan
Contact
[email protected]
Thomas Yau, MD
Principal Investigator
National Cheng Kung University Hospital
Tainan , , Taiwan More Info
Hsueh-Fang Hsieh
Contact
[email protected]
Wu-Chou Su, MD
Principal Investigator
Taipei Veterans General Hospital
Taipei , , Taiwan More Info
Ting-Fang Kung
Contact
[email protected]
Chueh-Chuan Yen, MD
Principal Investigator
Chang Gung Memorial Hospital
Taoyuan , , 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:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT03425279

Recruitment Status:

Recruiting

Sponsor:


BioAtla, Inc.

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