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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Phase 2 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
Treatment
VICCSAR20117
NCT03425279

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.

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