At a glance
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A Phase I,Open,Mono-center and Dose Escalation Study Investigating Tolerance and Pharmacokinetics of Single and Multiple Doses of Anti-PD-1 Monoclonal Antibody in Patients With Triple-negative Breast Cancer
In Brief
A Phase 1 clinical trial evaluating humanized anti-PD-1 monoclonal antibody toripalimab for Breast Cancer. Completed, enrolled 20 participants across 1 site.
Detailed Summary
This is a mono-center, open-label, phase 1 study evaluating the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with triple negative breast cancer who have failed in routine systemic treatment. The study will be conducted in 2 parts: dose escalation and cohort expansion to investigate tolerability and efficacy.
Study Details
Timeline
Interventions
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.