^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    PD-L1-targeted antibody-drug conjugate

    Related drugs:
    2d
    A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=167, Recruiting, Shanghai Henlius Biotech | N=90 --> 167 | Trial completion date: Jul 2028 --> Jan 2029
    Enrollment change • Trial completion date
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07) • HLX43
    12d
    SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=714, Recruiting, Seagen, a wholly owned subsidiary of Pfizer | N=315 --> 714 | Trial completion date: Apr 2028 --> Jan 2029 | Trial primary completion date: Apr 2027 --> Jan 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • PF-08046054
    18d
    C5851005: A Study to Learn About the Study Medicine Called PF-08046054/SGNPDL1V Versus Docetaxel in Adult Participants with Previously-treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-small-cell Lung Cancer (NSCLC) (2025-521281-97-00)
    P2/3, N=246, Recruiting, Pfizer Inc.
    New P2/3 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR mutation • ALK translocation
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    docetaxel • PF-08046054
    1m
    A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC (clinicaltrials.gov)
    P2, N=60, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR negative
    |
    Hetronifly (serplulimab) • HLX43
    1m
    A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=126, Not yet recruiting, Shanghai Henlius Biotech
    New P1/2 trial
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • BRAF wild-type
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07) • HLX43
    2ms
    A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=399 --> 9 | Trial completion date: Sep 2029 --> Apr 2026 | Trial primary completion date: Sep 2028 --> Mar 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zumrad (sasanlimab)
    2ms
    A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    HLX43
    3ms
    JSKN022 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=225, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    New P1 trial
    3ms
    A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    Hetronifly (serplulimab) • HLX43
    3ms
    HLX43-CC201: A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors (clinicaltrials.gov)
    P2, N=130, Recruiting, Shanghai Henlius Biotech | N=60 --> 130
    Enrollment change
    |
    HLX43
    3ms
    A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=340, Recruiting, Shanghai Henlius Biotech | N=174 --> 340
    Enrollment change
    |
    DDX5 (DEAD-Box Helicase 5)
    |
    PD-L1 expression
    |
    docetaxel • Hetronifly (serplulimab) • HLX43
    3ms
    A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    Hetronifly (serplulimab) • HLX43