The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.
Age: ≥18 years
Has a life expectancy of ≥3 months
Cohort 1: Subjects with HER2 expression in endometrial cancers (EC)
Cohort 2: Subjects with HER2 expression in cervical cancers (CC)
Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration
Subjects with history of severe heart disease
Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branch block, Grade 3 atrioventricular block
Active autoimmune diseases and inflammatory diseases
SystImmune Inc.
Lead sponsor