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
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.
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.
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There are 58 Locations for this study
Tucson Arizona, 85724, United States
Duarte California, 91010, United States More Info
Principal Investigator
La Jolla California, 92093, United States More Info
Principal Investigator
Los Angeles California, 90027, United States More Info
Principal Investigator
Los Angeles California, 90033, United States More Info
Principal Investigator
Orange California, 92868, United States More Info
Principal Investigator
San Francisco California, 94158, United States More Info
Principal Investigator
Whittier California, 90603, United States
Aurora Colorado, 80045, United States More Info
Principal Investigator
Denver Colorado, 80218, United States More Info
Principal Investigator
Fleming Island Florida, 32003, United States More Info
Principal Investigator
Fort Myers Florida, 33916, United States More Info
Principal Investigator
Hollywood Florida, 33028, United States
Saint Petersburg Florida, 34474, United States More Info
Principal Investigator
Tampa Florida, 33612, United States
Tampa Florida, 33612, United States More Info
Principal Investigator
Principal Investigator
West Palm Beach Florida, 33401, United States More Info
Principal Investigator
Augusta Georgia, 30912, United States More Info
Principal Investigator
Lexington Kentucky, 40503, United States
Lexington Kentucky, 40536, United States More Info
Principal Investigator
Louisville Kentucky, 40241, United States More Info
Principal Investigator
Baton Rouge Louisiana, 70809, United States More Info
Principal Investigator
Boston Massachusetts, 02215, United States
Las Vegas Nevada, 89169, United States
Las Vegas Nevada, 89169, United States
New York New York, 10016, United States More Info
Principal Investigator
New York New York, 10032, United States
Pinehurst North Carolina, 28374, United States More Info
Principal Investigator
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45219, United States More Info
Principal Investigator
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15232, United States More Info
Principal Investigator
Charleston South Carolina, 29407, United States More Info
Principal Investigator
Nashville Tennessee, 37203, United States More Info
Principal Investigator
Dallas Texas, 75230, United States More Info
Principal Investigator
Houston Texas, 77030, United States More Info
Principal Investigator
Salt Lake City Utah, 84112, United States More Info
Principal Investigator
Hamburg , 21075, Germany More Info
Principal Investigator
Athens , 11526, Greece More Info
Principal Investigator
Athens , 11527, Greece More Info
Principal Investigator
Piraeus , 18547, Greece More Info
Principal Investigator
Thessaloniki , 54622, Greece More Info
Principal Investigator
Thessaloniki , 57001, Greece More Info
Principal Investigator
Ravenna Emilia-Romagna, 48121, Italy More Info
Principal Investigator
Genoa Liguria, 16132, Italy More Info
Principal Investigator
Lodz Lodzkie, 93-33, Poland More Info
Principal Investigator
Tomaszów Mazowiecki Lodzkie, 97-20, Poland More Info
Principal Investigator
Lublin Lubelskie, 20-60, Poland More Info
Principal Investigator
Warsaw Mazowieckie, 08-78, Poland More Info
Principal Investigator
Poznan Wielkopolskie, 60-69, Poland More Info
Principal Investigator
Sevilla Andalusia, 41014, Spain More Info
Principal Investigator
Barcelona Catalonia, 08041, Spain More Info
Principal Investigator
Madrid , 28027, Spain More Info
Principal Investigator
Madrid , 28041, Spain More Info
Principal Investigator
Kaohsiung City , , Taiwan More Info
Principal Investigator
Tainan , , Taiwan More Info
Principal Investigator
Taipei City , , Taiwan More Info
Principal Investigator
Taoyuan City , , Taiwan More Info
Principal Investigator
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