NCT02742935

A Study to Evaluate the Safety and Tolerability of Using SHR-1210 by Advanced Solid Tumor Subjects

A Phase 1 Clinical Study on the Safety and Tolerability of PD-1 Antibody SHR-1210 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors. The primary objective is to assess safety and tolerability of SHR-1210 and identify recommended phase II doses of SHR-1210 in patients with advanced solid tumors.

Detailed description

This is an open-label, 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 90 days after the last dose of study treatment).

Conditions

• Solid Tumor
• Breast Cancer
• Gastrointestinal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	camrelizumab	A fully humanized anti-PD-1 monoclonal immunoglobulin (IgG4 subtype)

Timeline

• Start date: 2016-04-27
• Primary completion: 2019-05-06
• Completion: 2019-05-06
• First posted: 2016-04-19
• Last updated: 2023-02-27

Locations

1 site across 1 country: China