A Study to Evaluate the Safety and Tolerability of Using the SHR-1210 by Advanced Melanoma Subjects
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|ClinicalTrials.gov Identifier: NCT02738489|
Recruitment Status : Unknown
Verified March 2016 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was: Enrolling by invitation
First Posted : April 14, 2016
Last Update Posted : November 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm||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 Melanoma 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 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)|
|Estimated Enrollment :||36 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 Melanoma|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||April 2017|
Experimental: Injection SHR-1210
SHR-1210 injection, 60,200,400mg/dose, intravenous infusion over 30 minutes. Only one arm in this study
A fully human monoclonal immunoglobulin (IgG4 subtype)
- dose limited toxicity [ Time Frame: 56day ]
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): NCT02738489
|Cancer hospital affiliated to Beijing University|
|Beijing, Beijing, China|
|Study Director:||Yiding Xing, Doctor||Jiangsu Hengrui Pharmaceutical Co., LTD|