A Study to Evaluate the Safety and Tolerability of Using the SHR-1210 by Advanced Solid Tumor Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02721589|
Recruitment Status : Active, not recruiting
First Posted : March 29, 2016
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: SHR-1210||Phase 1|
This is an open-label, single center, nonrandomized, dose-escalation Phase 1 study to evaluate safety and tolerability of SHR-1210 in subjects with advanced solid tumors who have failed current standard antitumor therapies.
The safety and tolerability of SHR-1210 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, electrocardiogram (ECG), and adverse events. Evaluations of immune safety will also be conducted (immune-related adverse events (AEs), or labs of autoimmune sera, inflammatory events, and immunogenicity). Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.
Efficacy will be assessed every 8 weeks. The study consists of 3 periods: screening (up to 28 days before the first dose), treatment, and follow-up (up to 3 months after the last dose of study treatment).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single Center, Nonrandomized, Dose-Escalation Phase 1 Study to Evaluate Safety and Tolerability of SHR-1210 in Subjects With Advanced Solid Tumors|
|Actual Study Start Date :||April 6, 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Injection SHR-1210
Other Name: INCSHR01210
- Dose limited toxicity [ Time Frame: 28 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721589
|Cancer hospital affiliated to Zhongshan University|
|Guangzhou, Guangdong, China, 510060|
|Study Director:||Yiding Xing, Doctor||Jiangsu Hengrui Pharmaceutical Co., LTD|