An Open-label, Multicenter, Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Efficacy of BA3182, a Bispecific Epithelial Cell Adhesion Molecule (EpCAM)/CD3 Antibody, in Patients With Advanced Adenocarcinoma
Description
Brief Summary
The objective of this study is to assess safety and efficacy of BA3182 in Advanced
Adenocarcinoma
Detailed Description
This is a multi-center, open-label, Phase 1 study designed to evaluate the safety,
tolerability, PK, immunogenicity, and antitumor activity of BA3182 in patients with advanced
adenocarcinoma.
Phase
N/AInclusion and Exclusion Criteria
- Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma
- Age ≥ 18 years
- 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 active autoimmune disease or a documented history of autoimmune disease.
- 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 incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment.
- 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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