CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
humanized anti-PD-1 monoclonal antibodybiological
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/NCT03167853
NCT03167853Phase 1Completed

Phase Ib Study of Safety and Efficacy of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Patients With Advanced Neuroendocrine Tumors Following Failure of First-Line

Peking University·interventional·Posted May 30, 2017·Updated Jun 21, 2019

In Brief

A Phase 1 clinical trial evaluating humanized anti-PD-1 monoclonal antibody for Neuroendocrine Tumors. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This is a multi-center, open-label, phase Ib study evaluating safety and efficacy of the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with neuroendocrine tumors who have failed in previous systemic treatment. 40 patients are enrolled and injected with the humanized anti-PD-1 antibody 3mg/mg every 2 weeks until disease progresses or unacceptable toxicity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 30, 2017
Enrollment StartApr 6, 2017
Primary CompletionDec 11, 2018
Study CompletionMay 11, 2019
TodayJul 1, 2026
Enrollment to primary: 1.7 yearsPosted 9.1 years ago

Interventions

humanized anti-PD-1 monoclonal antibodybiological

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