Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
Trial Parameters
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Brief Summary
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.
Eligibility Criteria
Inclusion Criteria: * Patient is ≥ 18 years of age on the day of signing informed consent. * Male or female, female patient of childbearing potential must have negative pregnancy test. * Patient must have a performance status of ≤ 1 on the ECOG Performance Scale. * Patients must have a histological or cytological diagnosis of solid tumors and have metastatic disease or locally advanced disease. * Measurable disease as determined by RECIST 1.1 * Patient must have adequate organ function as indicated by the following laboratory values * Patient has voluntarily agreed to participate by giving written informed consent. * Female patients enrolled in the study, if having childbearing potential (WOCBP) and sexually active, must agree to use adequate and effective birth control starting with the first dose of study drug through 90 days after the last dose of study therapy. * Male patients, if sexually active, must agree to use adequate and effective methods of contraception starting with the f