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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT02742935
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • camrelizumab — BIOLOGICAL
    A fully humanized anti-PD-1 monoclonal immunoglobulin (IgG4 subtype)

Study Details

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.

Key Dates

Start date
Apr 27, 2016
Status verified
Feb 2023
Primary completion
May 6, 2019
Completion
May 6, 2019

Study Design

Enrollment
99 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: camrelizumab
    camrelizumab (SHR-1210) injection, 60,200,400mg/dose, intravenous infusion over 30 minutes, every 2 weeks.

Primary Outcome Measure

The severity of adverse events (AEs) determined as per NCI CTCAE V4.03. [ Time Frame: 28 days ]

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