Tumor
Conditions
Brief summary
The purpose of this study is to access the safety and tolerability of the study drug known as SHR-1316 in metastatic/advanced malignancies
Detailed description
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.
Interventions
DRUGSHR-1316
Monotherapy
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | at the end of cycle one(each cycle is 21 days) | incidence and severity of treatment-related adverse events |
| Dose-limiting toxicities (DLTs) | at the end of cycle one(each cycle is 21 days) | Number of participants with DLTs |
Countries
China
Contacts
Primary ContactGang Chen, PhD
Backup ContactYing Tian
Outcome results
None listed