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    DRUG:

    PH001

    i
    Other names: PH001, YK-029A, YK-209A
    Company:
    Suzhou Puhe Pharma
    Drug class:
    EGFR inhibitor
    Related drugs:
    1year
    Safety, tolerability, pharmacokinetics, and preliminary efficacy of YK-029A in treatment-naïve patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations: A phase I trial. (PubMed, J Thorac Oncol)
    YK-029A showed manageable safety and was tolerable in patients with NSCLC harboring EGFR mutations and showed promising antitumor activity in untreated patients with EGFR ex20ins mutations.
    P1 data • PK/PD data • Journal • EGFR exon 20 • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    PH001
    over1year
    Discovery of YK-029A, a novel mutant EGFR inhibitor targeting both T790 M and exon 20 insertion mutations, as a treatment for NSCLC. (PubMed, Eur J Med Chem)
    Furthermore, YK-029A exhibited significant antitumor activity in EGFRex20ins-driven patients-derived xenograft (PDX) models, preventing tumor progression or causing tumor regression at well-tolerated dosages. Based on the outcomes of preclinical efficacy and safety studies, YK-029A will enter phase Ⅲ clinical trials for the treatment of EGFRex20ins NSCLC.
    Journal
    |
    EGFR mutation • EGFR L858R • EGFR T790M • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    PH001
    over1year
    YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations (clinicaltrials.gov)
    P3, N=350, Not yet recruiting, Suzhou Puhe Pharmaceutical Technology Co., LTD
    New P3 trial • EGFR exon 20
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR L861Q • EGFR G719X • EGFR S768I • EGFR exon 20 mutation
    |
    cisplatin • carboplatin • pemetrexed • PH001
    over1year
    Assessing an Oral EGFR Inhibitor,YK-209A in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR (clinicaltrials.gov)
    P1/2, N=160, Recruiting, Suzhou Puhe Pharmaceutical Technology Co., LTD
    New P1/2 trial • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    PH001