NCT03133247

A Trial to Evaluate Safety and Tolerability of SHR-1316 in Cancer Patients

A Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Atridia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In many types of human tumors, PD-L1 is highly expressed. Such high expression has often been associated with poor prognosis in cancer patients. SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.

Detailed description

This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase I study of repeated doses of SHR-1316 in subjects with advanced or metastatic solid tumors who have failed current standard anti-tumor therapies.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SHR-1316	PD-L1

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-04-09
• Completion: 2019-07-05
• First posted: 2017-04-28
• Last updated: 2022-07-12

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study