^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    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
    29d
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • Enshuxing (enlonstobart)
    1m
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • cisplatin • carboplatin • paclitaxel • Enshuxing (enlonstobart)
    1m
    A multicenter, single-arm clinical study of enlonstobart combined with nab-paclitaxel and platinum drugs neoadjuvant therapy for locally advanced cervical cancer (ENLONG-001) (ChiCTR2400090024)
    P4, N=34, Not yet recruiting, Chinese PLA General Hospital; Chinese PLA General Hospital
    New P4 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • albumin-bound paclitaxel • Enshuxing (enlonstobart)
    1m
    A Phase Ⅰ/II Clinical Study of SYS6010 in combination with Enlonstobart ± chemotherapy in patients with locally advanced or metastatic NSCLC and other advanced solid tumor (ChiCTR2400089402)
    P1/2, N=540, Not yet recruiting, Shanghai East Hospital; CSPC Megalith Biopharmaceutical Co., Ltd.
    New P1/2 trial • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR mutation • ALK mutation • PD-L1 amplification
    |
    PD-L1 IHC 22C3 pharmDx
    |
    cisplatin • carboplatin • Enshuxing (enlonstobart)
    1m
    An open-label and multicenter Phase Ⅰ Clinical Study to Evaluate the Safety and Efficacy of SYS6010 in combination with Enlonstobart and Simmitinib in patients with advanced esophageal cancer (ChiCTR2400089300)
    P1, N=60, Not yet recruiting, The First Affiliated Hospital of Henan University of Science and Technology; The First Affiliated Hospital of Henan University of Science and Technolo
    New P1 trial • Combination therapy • Metastases
    |
    Enshuxing (enlonstobart) • simmitinib (SYHA1817)
    2ms
    Phase II study of enlonstobart (SG001), a novel PD-1 inhibitor in patients with PD-L1 positive recurrent/metastatic cervical cancer. (PubMed, Gynecol Oncol)
    SG001 monotherapy demonstrated durable anti-tumor activity with acceptable safety in patients with PD-L1 positive r/mCC with progression on or intolerance to the first-line platinum-based chemotherapy.
    P2 data • Journal • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • Enshuxing (enlonstobart)
    5ms
    Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=17, Terminated, CSPC Ouyi Pharmaceutical Co., Ltd. | N=66 --> 17 | Not yet recruiting --> Terminated; Internal strategy change. Not related to safety concerns.
    Enrollment change • Trial termination • Metastases
    |
    5-fluorouracil • leucovorin calcium • Enshuxing (enlonstobart) • irinotecan liposomal
    12ms
    A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma. (clinicaltrials.gov)
    P1/2, N=129, Not yet recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • paclitaxel • Enshuxing (enlonstobart) • albumin-bound docetaxel (CPO100)
    1year
    A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma. (clinicaltrials.gov)
    P1/2, N=129, Not yet recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    New P1/2 trial • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • paclitaxel • Enshuxing (enlonstobart) • albumin-bound docetaxel (CPO100)
    3years
    Study of the SG001 Injection for Patients With Relapsed or Metastatic Uterine Cervical Cancer (clinicaltrials.gov)
    P2, N=104, Recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Enshuxing (enlonstobart)
    3years
    A Study to Evaluate the Efficacy and Safety of SG001 in Combination With Nab-Paclitaxel in Patients With Advanced Triple-Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=79, Recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    PD-L1 expression • HER-2 negative • PD-L1 negative • ER negative • PGR negative
    |
    albumin-bound paclitaxel • Enshuxing (enlonstobart)
    3years
    A Study to Evaluate the Efficacy and Safety of SG001 in Combination With Nab-Paclitaxel in Patients With Advanced Triple-Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=79, Not yet recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    Clinical • New P2 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    PD-L1 expression • HER-2 negative • PD-L1 negative • ER negative • PGR negative
    |
    albumin-bound paclitaxel • Enshuxing (enlonstobart)
    3years
    Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=66, Not yet recruiting, CSPC Ouyi Pharmaceutical Co., Ltd. | Trial completion date: Aug 2021 --> Aug 2024 | Trial primary completion date: Aug 2021 --> Aug 2023
    Clinical • Trial completion date • Trial primary completion date
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1
    |
    5-fluorouracil • leucovorin calcium • Enshuxing (enlonstobart) • irinotecan liposomal
    over3years
    Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=66, Not yet recruiting, CSPC Ouyi Pharmaceutical Co., Ltd.
    Clinical • New P2 trial
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1
    |
    5-fluorouracil • leucovorin calcium • Enshuxing (enlonstobart) • irinotecan liposomal
    over3years
    Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC (clinicaltrials.gov)
    P2, N=126, Not yet recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Enshuxing (enlonstobart)
    over3years
    Study of the SG001 Injection for Patients With Relapsed or Metastatic Uterine Cervical Cancer (clinicaltrials.gov)
    P2, N=104, Not yet recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    Clinical • New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Enshuxing (enlonstobart)
    over4years
    Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours (clinicaltrials.gov)
    P1, N=192, Recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Dec 2020 --> Mar 2023 | Trial primary completion date: Oct 2020 --> Sep 2022
    Clinical • Enrollment open • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR • ALK mutation
    |
    Enshuxing (enlonstobart)