A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination with Nivolumab in Adult and Adolescent Patients 12 Years and Older with Advanced Solid Tumors
A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination with Nivolumab in Adult and Adolescent Patients 12 Years and Older with Advanced Solid Tumors
Mechanism of Action
BA3011, an anti-AXL antibody, is designed to have pH-sensitive binding to restrict its activity to the typically acidic tumor microenvironment. The Antibody target is AXL, a transmembrane that may be overexpressed in Non-Small Cell Lung Cancer.
Purpose
- About the safety and tolerability of the study agent alone or in combination with Nivolumab• How the study agent works with and without Nivolumab in fighting cancer cells (particularly in participants with sarcomas)
- How proteins that indicate the status of your disease are affected with use of the study agent
- How much of the study agent is absorbed into the blood and how fast it is removed
- If your body develops proteins that work against the study agent
- If research tests can be used in the future to predict who will benefit from BA3011
- If the study agent alone or in combination with Nivolumab prevents or delays tumor growth
- Patients must have measurable disease.
- 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.
- 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.
Lines of Therapy Restrictions: Received ≥1 regimen containing anthracycline anda maximum of 3 previous LOT (requirements for prior treatments do not apply to sarcoma subtypes for which no treatment is approved)
Location
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