CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors
Miscellaneous,
Pediatric Solid Tumors,
Pediatrics,
Sarcoma
Phase I/II
Both
Mol. targeted/Immunotherapy/Biologics
BA3011,
Nivolumab
Davis, Elizabeth
National
Vanderbilt University
05-20-2021
Eligibility
12 Years
BOTH
NO
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.
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.
