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    DRUG:

    pimurutamab (HLX07)

    i
    Other names: HLX07, HLX-07
    Company:
    Fosun Pharma
    Drug class:
    EGFR inhibitor
    Related drugs:
    3ms
    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)
    5ms
    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)
    over1year
    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)
    over1year
    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)
    2years
    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)
    over2years
    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)
    over2years
    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)
    over2years
    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)
    over2years
    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)
    over2years
    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)
    over2years
    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)
    over2years
    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, Not yet recruiting, Shanghai Henlius Biotech | Trial completion date: Apr 2023 --> Aug 2025 | Initiation date: Mar 2022 --> Aug 2022 | Trial primary completion date: Dec 2022 --> Jun 2024
    Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    cisplatin • 5-fluorouracil • Hetronifly (serplulimab) • pimurutamab (HLX07)
    over2years
    HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    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)
    over2years
    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
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07)
    almost3years
    A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Locally Advanced, Unresectable or Metastatic ESCC (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    cisplatin • 5-fluorouracil • Hetronifly (serplulimab) • pimurutamab (HLX07)
    almost3years
    A Randomized, Open-Label, Multicenter, Phase II Study of HLX07 (Anti-EGFR Antibody) In Combination With HLX10 (Anti-PD-1 Antibody) With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=156, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    albumin-bound paclitaxel • Hetronifly (serplulimab) • pimurutamab (HLX07)
    almost3years
    A phase 2 study of serplulimab plus HLX07 in patients with advanced head and neck tumours (ECHNO-ICHNO 2022)
    No TEAEs leading to permanent discontinuation of study drugs or death were reported. Conclusion The results above demonstrated a manageable safety profile and encouraging efficacy of serplulimab plus HLX07 in patients with R/M HNSCC who had failed platinum-based chemotherapy, supporting a new treatment option that warrants further investigations.
    Clinical • P2 data
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07)
    almost3years
    An Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 in Combination With Chemotherapy or Monotherapy in nsqNSCLC Patients With High EGFR Expression (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression • EGFR overexpression
    |
    docetaxel • pimurutamab (HLX07)
    almost3years
    HLX07Ib/II: The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors. (clinicaltrials.gov)
    P1/2, N=90, Active, not recruiting, Shanghai Henlius Biotech | Trial completion date: Oct 2021 --> Dec 2022 | Trial primary completion date: Sep 2021 --> Sep 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    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 • oxaliplatin • leucovorin calcium • pimurutamab (HLX07)
    3years
    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 | Not yet recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression • EGFR mutation
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07)
    3years
    HLX07Ib/II: The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors. (clinicaltrials.gov)
    P1/2, N=90, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    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 • oxaliplatin • leucovorin calcium • pimurutamab (HLX07)
    over3years
    A Randomized, Open-Label, Multicenter, Phase II Study of HLX07 (Anti-EGFR Antibody) In Combination With HLX10 (Anti-PD-1 Antibody) With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=156, Not yet recruiting, Shanghai Henlius Biotech
    Clinical • New P2 trial • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    albumin-bound paclitaxel • Hetronifly (serplulimab) • pimurutamab (HLX07)
    over3years
    Phase I first-in-human study of HLX07, a novel and improved recombinant anti-EGFR humanized monoclonal antibody, in patients with advanced solid cancers. (PubMed, Invest New Drugs)
    Anti-HLX07 antibodies were not detected in any patients. Conclusion HLX07 was well tolerated (at dose levels up to 800 mg/week) and promising in patients with advanced solid cancers.Clinical Trial Registration: The study was registered at ClinicalTrials.gov : NCT02648490 (Jan 7, 2016).
    Clinical • P1 data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    pimurutamab (HLX07)
    over4years
    Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors (clinicaltrials.gov)
    P2, N=56, Not yet recruiting, Shanghai Henlius Biotech
    Clinical • New P2 trial • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression • EGFR mutation
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07)