A Phase 1 Study of SHR-A2102 in Subjects With Advanced Solid Tumors.

This is a first in human, open-label, single-arm, multicenter dose escalation and expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A2102 and preliminary anti-tumor efficacy

Inclusion Criteria:Ability to understand and the willingness to sign a written informed consent document；Aged ≥18 years old;Histologically or cytologically confirmed advanced or metastatic malignant tumor;Presence of at least one measurable lesion in agreement to RECIST criteria;Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;Life expectancy ≥3 months;Adequate organ performance based on laboratory blood tests;Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.Exclusion Criteria:Previous received anti-cancer systemic therapy including chemo-therapy, radiation therapy, target therapy or immuno-therapy within 4 weeks before the first dose;Previous received experimental medication or therapy within 4 weeks before the first dose;Previous therapeutic surgery within 4 weeks;Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.Known allergic to any compound of SHR-A2102;Patients with uncontrolled or active brain metastasis；Patients with clinical significant lung disease;Patients with history of autoimmune diseases;Known active hepatitis B or C infection;Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.