A Study to Evaluate the Safety and Tolerability of Using the SHR-1210 by Advanced Solid Tumor Subjects
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|ClinicalTrials.gov Identifier: NCT02742935|
Recruitment Status : Active, not recruiting
First Posted : April 19, 2016
Last Update Posted : January 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breastcancer Gastrointestinal Cancer||Biological: 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 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 14 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)|
|Actual Enrollment :||99 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 Tumor|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Experimental: Injection SHR-1210
SHR-1210 injection, 60,200,400mg/dose, intravenous infusion over 30 minutes.
A fully human monoclonal immunoglobulin (IgG4 subtype)
- dose limited toxicity [ Time Frame: 28day ]according to NCI CTCAE V4.03 to evaluate the toxicity
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): NCT02742935
|Cancer Hospital Chinese Academy of Medical Sciences|
|Beijing, Beijing, China|
|Study Director:||Qing Yang, Doctor||Jiangsu Hengrui Pharmaceutical Co., LTD|