A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors
Trial Parameters
Brief Summary
This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.
Eligibility Criteria
Inclusion Criteria: * Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form. * Male or female subjects aged 18 to 80 years (including 18 and 80 years). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Phase Ia：Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). Phase Ib：Only local advanced or metastatic UC tumors. * Subjects must have received ICIs or GC/GP therapies in the previous treatment. * Subjects must submit tumor tissues for test. * Life expectancy of ≥ 3 months. * Subjects must have measurable disease according to RECIST (version 1.1). * Adequate organ functions. * Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy. * Subjects are willing to follow study procedures. Exclusion Criter