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    DRUG:

    HLX43

    i
    Other names: HLX43, HLX 43, HLX-43, YL222, YL-222
    Associations

    News

    Trials
    Company:
    Fosun Pharma, MediLink
    Drug class:
    Topoisomerase I inhibitor, PD-L1-targeted antibody-drug conjugate
    Related drugs:
    Associations

    News

    Trials
    1m
    A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=174, Recruiting, Shanghai Henlius Biotech | N=36 --> 174
    Enrollment change
    |
    DDX5 (DEAD-Box Helicase 5)
    |
    PD-L1 expression
    |
    HLX43
    2ms
    A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=36, Recruiting, Shanghai Henlius Biotech | Trial completion date: Nov 2025 --> Nov 2027 | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    DDX5 (DEAD-Box Helicase 5)
    |
    PD-L1 expression
    |
    HLX43
    3ms
    A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=105, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Hetronifly (serplulimab) • HLX43
    3ms
    APhase II Clinical Study to Evaluate HLX43 in Subjects with Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=243, Recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    HLX43
    4ms
    A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy (clinicaltrials.gov)
    P2, N=90, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HLX43
    4ms
    A Phase II Clinical Study to Evaluate HLX43 in Subjects with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=90, Recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    HLX43
    5ms
    A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination with Serplulimab in Patients with Advanced/metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=105, Not yet recruiting, Shanghai Henlius Biotech
    New P1/2 trial
    |
    Hetronifly (serplulimab) • HLX43
    5ms
    HLX43-CC201: A Phase II Clinical Study to Evaluate HLX43 in Patients with Recurrent/Metastatic CC Failed or Intolerance to Standard Therapy (clinicaltrials.gov)
    P2, N=60, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HLX43
    5ms
    A Phase II Study to Evaluate HLX43 in Subjects with Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    HLX43
    5ms
    A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy (clinicaltrials.gov)
    P2, N=60, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HLX43
    6ms
    A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic CC Failed or Intolerance to Standard Therapy (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    HLX43
    6ms
    A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    HLX43
    7ms
    A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial • Metastases
    |
    HLX43
    over1year
    A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=36, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    DDX5 (DEAD-Box Helicase 5)
    |
    PD-L1 expression
    |
    HLX43
    over1year
    A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, Shanghai Henlius Biotech
    New P1 trial • Metastases
    |
    DDX5 (DEAD-Box Helicase 5)
    |
    PD-L1 expression
    |
    HLX43
    almost2years
    Preclinical activity of HLX43, a PD-L1-targeting ADC, in multiple PD-1/PD-L1 refractory/resistant models (ESMO 2023)
    Conclusions HLX43 showed promising efficacy and tolerability in preclinical assessments. It may offer a novel treatment for PD-1/PD-L1 inhibitor R/R cancers like NSCLC, HNSCC, ESCC, MEL, and OVC.
    Preclinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-1 (Programmed cell death 1)
    |
    PD-L1 expression • PD-L1-L
    |
    HLX43