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Overview

Primary objective: To evaluate the safety and tolerability of NWRD06 naked plasmid DNA injection in patients after radical surgery for hepatocellular carcinoma, and to explore the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of NWRD06. Secondary objective: To evaluate the immunogenicity of NWRD06 naked plasmid DNA injection in patients after radical surgery for hepatocellular carcinoma.

Start Date06 Dec 2023

Sponsor / Collaborator

Newish Technology (Taizhou) Co., Ltd.Startup

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NCT06088459 / RecruitingPhase 1

Phase I Safety and Immunogenicity Study of NWRD06 in Hepatocellular Carcinoma Patients After Radical Resection

This is a dose escalation Phase 1 clinical study to evaluate the safety and immunogenicity of Glypican3 (GPC3)-targeted DNA plasmid vaccine (NWRD06) in patients with GPC3-positive primary hepatocellular carcinoma after radical resection.

Start Date01 Nov 2023

Sponsor / Collaborator

Newish Technology (Taizhou) Co., Ltd.Startup

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