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    DRUG:

    pimurutamab (HLX07)

    i
    Other names: HLX07, HLX-07, HLX 07
    Company:
    Fosun Pharma
    Drug class:
    EGFR inhibitor
    Related drugs:
    12ms
    Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC (clinicaltrials.gov)
    P2, N=29, Recruiting, Wuhan Union Hospital, China | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07)
    over1year
    Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, Wuhan Union Hospital, China
    New P2 trial • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07)
    over1year
    Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC (clinicaltrials.gov)
    P2, N=75, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2024 --> Sep 2024
    Enrollment closed • Trial primary completion date • Metastases
    |
    cisplatin • Hetronifly (serplulimab) • pimurutamab (HLX07)
    over2years
    HLX07Ib/II: The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors. (clinicaltrials.gov)
    P1/2, N=56, Completed, Shanghai Henlius Biotech | Active, not recruiting --> Completed | N=90 --> 56
    Trial completion • Enrollment change • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • IL2RA (Interleukin 2 receptor, alpha) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    cisplatin • carboplatin • gemcitabine • paclitaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • pimurutamab (HLX07)
    almost3years
    Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors (clinicaltrials.gov)
    P2, N=131, Active, not recruiting, Shanghai Henlius Biotech | N=56 --> 131 | Trial completion date: Oct 2023 --> Jun 2025 | Trial primary completion date: Dec 2022 --> May 2024
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • 5-fluorouracil • Hetronifly (serplulimab) • pimurutamab (HLX07)
    over3years
    A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC (clinicaltrials.gov)
    P2, N=60, Recruiting, Shanghai Henlius Biotech | Active, not recruiting --> Recruiting | Initiation date: Jun 2019 --> Aug 2022
    Enrollment open • Trial initiation date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    cisplatin • 5-fluorouracil • Hetronifly (serplulimab) • pimurutamab (HLX07)
    over3years
    A Study to Evaluate the Efficacy and Safety of HLX07 in nsqNSCLC Patients With High EGFR Expression (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai Henlius Biotech | Initiation date: Jun 2022 --> Feb 2023
    Trial initiation date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression • EGFR overexpression
    |
    carboplatin • docetaxel • pemetrexed • pimurutamab (HLX07)
    over3years
    Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors (clinicaltrials.gov)
    P2, N=56, Active, not recruiting, Shanghai Henlius Biotech | Trial primary completion date: May 2022 --> Dec 2022
    Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression • EGFR mutation
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07)
    over3years
    A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC (clinicaltrials.gov)
    P2, N=156, Recruiting, Shanghai Henlius Biotech | Trial completion date: Oct 2023 --> Oct 2024
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    albumin-bound paclitaxel • Hetronifly (serplulimab) • pimurutamab (HLX07)
    over3years
    A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Active, not recruiting | Initiation date: Aug 2022 --> Jun 2019
    Enrollment closed • Trial initiation date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    cisplatin • 5-fluorouracil • Hetronifly (serplulimab) • pimurutamab (HLX07)
    over3years
    Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Shanghai Henlius Biotech | Initiation date: Apr 2022 --> Jul 2022
    Trial initiation date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Hetronifly (serplulimab) • pimurutamab (HLX07)
    over3years
    HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative • PD-L1 negative
    |
    capecitabine • oxaliplatin • Hetronifly (serplulimab) • pimurutamab (HLX07)