A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody in Patients With Advanced Solid Tumors
Description
Brief Summary
The objective of this study is to assess safety and efficacy of BA3071 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 BA3071 in combination with a PD-1
blocking antibody, nivolumab, in patients with advanced solid tumors.
Phase
N/AInclusion and Exclusion Criteria
- Patients must have measurable disease.
- Age ≥ 18 years
- CLTA-4 blocking-antibody naïve.
- Adequate renal function
- Adequate liver function
- Adequate hematological function
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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 BA3071 administration.
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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