Status:
UNKNOWN
Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Male or female ≥18 years of age
- Subjects with confirmed advanced malignancies (histologically or cytologically)
- ECOG Performance status of 0 or 1
- Adequate organ functions
- Life expectancy ≥12 weeks;
Exclusion
- Subjects with active autoimmune disease.
- Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 4 weeks of the first dose of trial treatment
- Previous received PD-1 or PD-L1 therapy
- Known Active central nervous system (CNS) metastases
- Known Clinically significant cardiovascular condition
- Active infection or an unexplained fever \>38.5°C
- History of immunodeficiency
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2019
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT03474289
Start Date
March 1 2018
End Date
October 31 2019
Last Update
March 22 2018
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China