CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 401 enrolled
Drug / intervention
3 mg/kg anti-PD-1 mAb JS001 Q2W +2 morebiological
Likely dose
3 mg/kg anti-PD-1 mAb JS001 Q2Wfrom 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/NCT02915432
NCT02915432Phase 2Unknown

A Multi-Center, Open Label Phase Ib/II Clinical Study to Evaluate JS001 in Patients With Advanced Gastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Nasopharyngeal Carcinoma and Head and Neck Squamous Cell Carcinoma

Shanghai Junshi Bioscience Co., Ltd.·interventional·Posted Sep 27, 2016·Updated Dec 13, 2021

In Brief

A Phase 2 clinical trial evaluating 3 mg/kg anti-PD-1 mAb JS001 Q2W, 360 mg anti-PD-1 mAb JS001 Q3W, and 1 other intervention for Gastric Adenocarcinoma and 3 related conditions. Targeting 401 participants across 23 sites.

Detailed Summary

The purpose of this study is to preliminarily evaluate anti-tumor activity of a Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Infusion (JS001) in treating advanced gastric adenocarcinoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and head and neck squamous cell carcinoma and to determine the recommended phase II dose (RP2D)

Study Details

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

Timeline

Phase 2UnknownOverdue
2017201820192020202120222023202420252026
First PostedSep 27, 2016
Enrollment StartDec 1, 2016
Primary CompletionFeb 19, 2020
Study CompletionApr 30, 2022
TodayJul 1, 2026
Enrollment to primary: 3.2 yearsPosted 9.8 years ago

Interventions

3 mg/kg anti-PD-1 mAb JS001 Q2Wbiological

This study is planned to conduct the 3 mg/kg dose group study at first. After enrollment, the subjects will be administered every 2 weeks (Q2W) with 4 weeks as a cycle, until absence of further benefits, acceptable toxicity, investigator decision, consent withdrawal or death. If patient experiences 1st onset of disease progression and investigator judges that patient will obtain clinical benefit from the study treatment, patient can continue the study treatment after the discussion between investigator and medical monitor from sponsor or authorized CRO and approval is obtained afterwards. If the subject develops 2nd disease progression after 1st disease progression, he/she should permanently withdraw from the study treatment.

360 mg anti-PD-1 mAb JS001 Q3Wbiological

Subjects will receive corresponding regimen of standard first-line chemotherapy combined with JS001 360 mg once every 3 weeks (Q3W). JS001 360 mg Q3W can be administrated after the end of chemotherapy until absence of further benefits judged by the investigator, disease progression, occurrence of intolerable toxicity, investigator's decision, and withdrawal of informed consent by the subject, or death.

240mg anti-PD-1 mAb JS001 Q3Wbiological

Subjects will receive corresponding regimen of standard first-line chemotherapy combined with JS001 240 mg once every 3 weeks (Q3W). JS001 240 mg Q3W can be administrated after the end of chemotherapy until absence of further benefits judged by the investigator, disease progression, occurrence of intolerable toxicity, investigator's decision, and withdrawal of informed consent by the subject, or death.