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
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.
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.
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There are 29 Locations for this study
Tucson Arizona, 85724, United States More Info
Principal Investigator
Los Angeles California, 90027, United States More Info
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Los Angeles California, 90033, United States More Info
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Los Angeles California, 90048, United States More Info
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San Francisco California, 94158, United States More Info
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Aurora Colorado, 80045, United States More Info
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Denver Colorado, 80218, United States More Info
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Washington District of Columbia, 20010, United States More Info
Principal Investigator
Tampa Florida, 33612, United States More Info
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Chicago Illinois, 60611, United States More Info
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Louisville Kentucky, 40202, United States More Info
Principal Investigator
Boston Massachusetts, 02114, United States More Info
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Boston Massachusetts, 02215, United States More Info
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Las Vegas Nevada, 89169, United States
Buffalo New York, 14263, United States More Info
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New York New York, 10032, United States More Info
Principal Investigator
New York New York, 10065, United States More Info
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Durham North Carolina, 27710, United States More Info
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Winston-Salem North Carolina, 27157, United States More Info
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Cleveland Ohio, 44106, United States More Info
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Columbus Ohio, 43205, United States More Info
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Portland Oregon, 97239, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19104, United States More Info
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Nashville Tennessee, 37203, United States More Info
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Nashville Tennessee, 37232, United States More Info
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Dallas Texas, 75230, United States More Info
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Houston Texas, 77030, United States More Info
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Salt Lake City Utah, 84112, United States More Info
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Seattle Washington, 98109, United States More Info
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Tainan , , Taiwan More Info
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Taipei , , Taiwan More Info
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Taoyuan , , Taiwan More Info
Principal Investigator
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