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    DRUG:

    TRX-221

    i
    Other names: TRX-221
    Company:
    Therapex
    Drug class:
    EGFR inhibitor, EGFR C797S inhibitor
    Related drugs:
    5d
    TRX-221-001: A Study to Investigate Safety, Tolerability, PK and Anti-tumor Activity of TRX-221 in EGFRm NSCLC Patients (clinicaltrials.gov)
    P1/2, N=19, Terminated, Therapex Co., Ltd | N=115 --> 19 | Trial completion date: Jun 2028 --> Dec 2025 | Recruiting --> Terminated | Trial primary completion date: Jun 2027 --> Dec 2025; Sponsor's decision
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    EGFR mutation
    |
    TRX-221
    almost2years
    A Study to Investigate Safety, Tolerability, PK and Anti-tumor Activity of TRX-221 in EGFRm NSCLC Patients (clinicaltrials.gov)
    P1/2, N=115, Recruiting, Therapex Co., Ltd | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor)
    |
    TRX-221
    over2years
    A Study to Investigate Safety, Tolerability, PK and Anti-tumor Activity of TRX-221 in EGFRm NSCLC Patients (clinicaltrials.gov)
    P1/2, N=115, Not yet recruiting, Therapex Co., Ltd
    New P1/2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    TRX-221
    3years
    TRX-221, a novel 4th-generation EGFR inhibitor for overcoming C797S mutation-mediated acquired resistance in NSCLC (AACR 2023)
    With favorable DMPK profiles, once-daily oral dosing of TRX-221 induced strong anti-tumor effects in a dose-dependent manner in a variety of osimertinib-resistant CDX and PDX models. As a reversible, selective, and broad-spectrum 4th-generation EGFR-TKI, TRX-221 is currently undergoing IND-enabling studies and shows strong potential as a therapeutic solution to treat advanced NSCLC patients harboring EGFR mutations.
    Preclinical
    |
    EGFR mutation • EGFR L858R • EGFR T790M • EGFR wild-type • EGFR overexpression • EGFR C797S
    |
    Tagrisso (osimertinib) • TRX-221