Study of JS001 in Patients With Advanced Neuroendocrine Tumors
NCT03167853 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2019-06-21
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.
Conditions
Interventions
- BIOLOGICAL
-
humanized anti-PD-1 monoclonal antibody
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.
Sponsors & Collaborators
-
Shanghai Junshi Bioscience Co., Ltd.
collaborator OTHER -
Peking University
lead OTHER
Principal Investigators
-
Lin Shen, MD, PhD · Peking University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-06
- Primary Completion
- 2018-12-11
- Completion
- 2019-05-11
Countries
- China
Study Locations
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