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    Home > Medical News > Medical Research Articles > Phase I clinical trial of three-drug combination anti-CD40, anti-CTLA-4 and anti-PD-1 monoclonal antibody was approved by the National Medical Products Administration of China

    Phase I clinical trial of three-drug combination anti-CD40, anti-CTLA-4 and anti-PD-1 monoclonal antibody was approved by the National Medical Products Administration of China

    • Last Update: 2022-05-02
    • Source: Internet
    • Author: User
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    NMPA Approves Euho Pharma to Conduct a Phase I International Multicenter Clinical Research Trial in China: Safety, Tolerability and Pharmacokinetics of a Combination of YH003, YH001 and Pembrolizumab in Subjects with Advanced Solid Tumors A multicenter, open-label, phase I dose-escalation study of the drug (protocol number: YH003005)
    .


    The study is an international multi-center clinical trial, and participating countries include Australia and China


    The Phase I dose escalation study of YH003 combined with toripalimab in subjects with advanced solid tumors in Australia (protocol number: YH003002) evaluated the safety, tolerability, pharmacokinetics and preliminary results of YH003 antitumor efficacy
    .


    YH003 combined with toripalimab showed good safety and tolerability.
    Of the 20 patients enrolled in the group, 2 patients had grade 3 AEs related to YH003, which were neutropenia and elevated transaminases.


    The clinical phase I dose escalation study of YH001 combined with toripalimab in subjects with advanced solid tumors in Australia (protocol number: YH001002) evaluated the safety, tolerability and pharmacokinetic characteristics of YH001 and preliminary antitumor efficacy
    .


    Twenty-four patients with advanced solid tumors were included in the study, and YH001 combined with toripalimab showed good tolerability and safety


    In this regard, Dr.
    Shen Yuelei, CEO of Euho Pharma, said, "The NMPA approval of the Phase I clinical trial of the three-drug combination YH001, YH003 and pembrolizumab is a milestone for Euho Pharma.
    After the approval to carry out the Phase II clinical study in combination with PD-1, we were approved by the Chinese Food and Drug Administration to carry out the Phase I clinical study of the three-drug combination, which is an affirmation of the clinical safety and preliminary efficacy of YH001 and YH003
    .


    He team can advance the clinical progress so efficiently, we will continue to actively promote the clinical trials of YH001 and YH003 in China and around the world


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