CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
humanized anti-PD-1 monoclonal antibody toripalimabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02857166
NCT02857166Phase 1Completed

Phase IA Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Recombinant Humanized Anti-PD-1 Monoclonal Antibody (JS001) in Patients With Advanced Solid Tumors

Shanghai Junshi Bioscience Co., Ltd.·interventional·Posted Aug 5, 2016·Updated Oct 23, 2019

In Brief

A Phase 1 clinical trial evaluating humanized anti-PD-1 monoclonal antibody toripalimab for Solid Tumors. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerance and Dose-Limiting Toxicity (DLT) of Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with advanced solid tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 5, 2016
Enrollment StartMar 1, 2016
Primary CompletionSep 1, 2017
Study CompletionDec 1, 2018
TodayJul 1, 2026
Enrollment to primary: 1.5 yearsPosted 9.9 years ago

Interventions

humanized anti-PD-1 monoclonal antibody toripalimabbiological

humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.