CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
Purpose
The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.
Conditions
- Undifferentiated Pleomorphic Sarcoma
- Myxofibrosarcoma
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- 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 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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BA3011 |
Phase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor. |
|
|
Experimental Combination Therapy |
Phase 2: BA3011 in combination with PD-1 inhibitor. |
|
Recruiting Locations
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- BioAtla, Inc.
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 biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors. Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024). Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).