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    DRUG:

    retlirafusp alfa (SHR-1701)

    i
    Other names: SHR-1701, SHR1701, SHR 1701
    Company:
    Dong-A, Jiangsu Hengrui Pharma
    Drug class:
    PD-L1 inhibitor, TGF-β R2 kinase inhibitor
    Related drugs:
    30d
    PD1/TGFβ In Combination With EZH2 And Chemotherapy For First - Line Treatment Of Gastric Cancer (clinicaltrials.gov)
    P2, N=36, Recruiting, The First Affiliated Hospital of Zhengzhou University
    New P2 trial
    |
    capecitabine • oxaliplatin • retlirafusp alfa (SHR-1701) • zeprumetostat (SHR-2554)
    1m
    A phase 1b/2 study of first-line anti-PD-L1/ TGF-βRII fusion protein SHR-1701 combined with nab-paclitaxel and gemcitabine for advanced pancreatic ductal adenocarcinoma. (PubMed, Signal Transduct Target Ther)
    The interactions within tumor microenvironment were involved disease progression. Overall, first-line SHR-1701 plus AG showed promising anti-tumor activity and controllable safety in advanced or metastatic pancreatic ductal adenocarcinoma, and features of patients more likely to benefit from the combination were drawn.
    P1/2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    TGFB1 (Transforming Growth Factor Beta 1) • CA 19-9 (Cancer antigen 19-9)
    |
    gemcitabine • albumin-bound paclitaxel • retlirafusp alfa (SHR-1701)
    2ms
    Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects (clinicaltrials.gov)
    P2, N=200, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    retlirafusp alfa (SHR-1701) • zeprumetostat (SHR-2554) • SHR-A2102 • AiRuiLi (adebrelimab)
    3ms
    A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination with Other Antitumor Therapies in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma (ChiCTR2500110933)
    P2, N=366, Recruiting, Harbin Medical University Cancer Hospital; Harbin Medical University Cancer Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    PD-L1 expression • HER-2 expression
    |
    trastuzumab rezetecan (SHR-A1811) • retlirafusp alfa (SHR-1701) • zeprumetostat (SHR-2554) • AiRuiLi (adebrelimab) • garetatug rezetecan (SHR-A1904)
    4ms
    Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects (clinicaltrials.gov)
    P2, N=200, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P2 trial
    |
    retlirafusp alfa (SHR-1701) • zeprumetostat (SHR-2554) • SHR-A2102 • AiRuiLi (adebrelimab)
    5ms
    Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=351, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    trastuzumab rezetecan (SHR-A1811) • retlirafusp alfa (SHR-1701) • zeprumetostat (SHR-2554) • garetatug rezetecan (SHR-A1904)
    5ms
    Efficacy and safety of SHR-1701 combined with chemoradiotherapy as neoadjuvant treatment for locally advanced rectal cancer. (PubMed, Cancer Lett)
    Patients received concurrent SHR-1701 and CRT, followed by two cycles of SHR-1701 plus XELOX and subsequent TME surgery. One patient experienced fatal immune-mediated myocarditis prior to surgery. Overall, the addition of SHR-1701 to CRT demonstrated encouraging efficacy and manageable safety in high-risk LARC, supporting further investigation in larger randomized trials.
    Journal
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    capecitabine • oxaliplatin • retlirafusp alfa (SHR-1701)
    5ms
    CASTLE-ZS-03: Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced Intrahepatic Cholangiocarcinoma. (clinicaltrials.gov)
    P2, N=36, Not yet recruiting, Fudan University
    New P2 trial
    |
    retlirafusp alfa (SHR-1701) • famitinib (SHR 1020)
    5ms
    A Phase II clinical study of SHR-1701 combined with albumin paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer with malignant pleural effusion (ChiCTR2200062197)
    P=N/A, N=42, Recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    carboplatin • albumin-bound paclitaxel • retlirafusp alfa (SHR-1701)
    6ms
    Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=351, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P2 trial
    |
    trastuzumab rezetecan (SHR-A1811) • retlirafusp alfa (SHR-1701) • zeprumetostat (SHR-2554) • garetatug rezetecan (SHR-A1904)
    8ms
    SHR-1701-III-301: A Clinical Studyf of SHR-1701 or Placebo in Combination With BP102 and XELOX in the First-line Treatment of mCRC (clinicaltrials.gov)
    P2/3, N=62, Terminated, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=439 --> 62 | Recruiting --> Terminated; Adjustment of the Company's R&D Strategy
    Enrollment change • Trial termination
    |
    capecitabine • oxaliplatin • retlirafusp alfa (SHR-1701)
    9ms
    SHR-A1811-Ib/II-205: Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer (clinicaltrials.gov)
    P2, N=76, Active, not recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=258 --> 76 | Trial primary completion date: Jul 2026 --> Apr 2025 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    5-fluorouracil • capecitabine • oxaliplatin • trastuzumab rezetecan (SHR-A1811) • retlirafusp alfa (SHR-1701) • AiRuiLi (adebrelimab)