Trials / Unknown
UnknownNCT03474289
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1316 | Monotherapy |
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2019-01-30
- Completion
- 2019-10-31
- First posted
- 2018-03-22
- Last updated
- 2018-03-22
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03474289. Inclusion in this directory is not an endorsement.