Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors

A Phase 1 Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors

The purpose of this study is to access the safety and tolerability of the study drug known as SHR-1316 in metastatic/advanced malignancies

This is an open-label, non-randomized, dose escalation/expansion phase I study, SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Inclusion Criteria:

1. Male or female ≥18 years of age
2. Subjects with confirmed advanced malignancies (histologically or cytologically)
3. ECOG Performance status of 0 or 1
4. Adequate organ functions
5. Life expectancy ≥12 weeks;

Exclusion Criteria:

1. Subjects with active autoimmune disease.
2. Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 4 weeks of the first dose of trial treatment
3. Previous received PD-1 or PD-L1 therapy
4. Known Active central nervous system (CNS) metastases
5. Known Clinically significant cardiovascular condition
6. Active infection or an unexplained fever >38.5°C
7. History of immunodeficiency