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    DRUG:

    Enshuxing (enlonstobart)

    i
    Other names: SG001, SG 001, SYSA1802, SG-001, SYSA-1802, SYSA 1802
    Associations

    News

    Trials
    Company:
    CSPC Pharma, Sumgen Biotech
    Drug class:
    PD1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    4d
    Phase 1b Multicenter Study of SG001, a Humanized Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors. (PubMed, Drug Des Devel Ther)
    The safety profile was well tolerated. ClinicalTrials.gov identifier: NCT03852823.
    Clinical • P1 data • Journal
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    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
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    Enshuxing (enlonstobart)
    6d
    SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
    New P2 trial
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    Enshuxing (enlonstobart) • SYS6010
    8d
    A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma. (clinicaltrials.gov)
    P2/3, N=737, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
    New P2/3 trial • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
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    EGFR expression
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    cisplatin • paclitaxel • 5-fluorouracil • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • capecitabine • Enshuxing (enlonstobart) • SYS6010
    1m
    A Phase II Clinical Study of SYS6002 in combination with SG001 in patients with advanced urothelial cancer and other advanced solid tumor (ChiCTR2500107496)
    P2, N=148, Recruiting, Fudan University Shanghai Cancer Center; CSPC Megalith Biopharmaceutical Co., Ltd..
    New P2 trial
    |
    Enshuxing (enlonstobart)
    3ms
    SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC (clinicaltrials.gov)
    P2, N=430, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd. | N=250 --> 430 | Initiation date: May 2025 --> Aug 2025 | Trial primary completion date: Sep 2027 --> Dec 2027
    Enrollment change • Trial initiation date • Trial primary completion date
    |
    becotarug (JMT101) • Enshuxing (enlonstobart)
    6ms
    The efficacy and safety of combined chemotherapy and immunotherapy as neoadjuvant therapy for advanced cervical cancer (ChiCTR2500100935)
    P=N/A, N=20, Recruiting, Jilin Cancer Hospital; Jilin Cancer Hospital
    New trial
    |
    carboplatin • paclitaxel • Enshuxing (enlonstobart)
    6ms
    JSKN003 Combined Treatment of HER2-positive Gastric Cancer (clinicaltrials.gov)
    P2, N=153, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P2 trial
    |
    Herceptin (trastuzumab) • capecitabine • oxaliplatin • anbenitamab (KN026) • Enshuxing (enlonstobart) • anbenitamab repodatecan (JSKN003)
    6ms
    SYS6002 Plus JMT101 and Enlonstobart Injection as First-Line Treatment for HNSCC (clinicaltrials.gov)
    P2, N=250, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
    New P2 trial
    |
    becotarug (JMT101) • Enshuxing (enlonstobart)
    7ms
    A Single-Arm Exploratory Study of Enlansibumab Sequentially Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer (clinicaltrials.gov)
    P2, N=34, Not yet recruiting, Chongqing University Cancer Hospital
    New P2 trial
    |
    Enshuxing (enlonstobart)
    11ms
    Safety and efficacy study of Irinotecan Hydrochloride Liposome combined with Anlotinib and Enlonstobart in second-line treatment of advanced colorectal cancer (ChiCTR2400092769)
    P=N/A, N=30, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University
    New trial
    |
    Focus V (anlotinib) • irinotecan • Enshuxing (enlonstobart)
    1year
    Enlonstobart: First Approval. (PubMed, Drugs)
    Phase III clinical evaluation of enlonstobart for use as first-line treatment (in combination with chemotherapy ± bevacizumab) in patients with recurrent or metastatic PD-L1-positive cervical cancer is also underway in China. Additionally, phase II clinical development of enlonstobart (as a part of combination therapy) for use against a range of other solid tumour types is continuing. This article summarises the milestones in the development of enlonstobart leading to this first approval for recurrent or metastatic cervical cancer.
    Review • Journal
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
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    Avastin (bevacizumab) • Enshuxing (enlonstobart)
    1year
    A multicenter, single-arm clinical study of enlonstobart combined with chemoradiotherapy for locally advanced cervical cancer (ENLONG-003) (ChiCTR2400091264)
    P4, N=50, Not yet recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University of
    New P4 trial • Metastases
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
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    Avastin (bevacizumab) • cisplatin • carboplatin • paclitaxel • Enshuxing (enlonstobart)