Status:
COMPLETED
CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
Lead Sponsor:
BioAtla, Inc.
Conditions:
Undifferentiated Pleomorphic Sarcoma
Myxofibrosarcoma
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.
Detailed Description
This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of mecbotamab vedotin (BA3011), a conditionally active bio...
Eligibility Criteria
Inclusion
- 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
- 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 well as 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.
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2025
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT03425279
Start Date
February 15 2018
End Date
January 8 2025
Last Update
September 23 2025
Active Locations (40)
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1
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
3
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
Tower Hematology Oncology Medical Group
Los Angeles, California, United States, 90048