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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:
    17d
    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)
    1m
    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)
    3ms
    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)
    3ms
    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)
    3ms
    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)
    3ms
    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)
    4ms
    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)
    4ms
    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)
    7ms
    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)
    8ms
    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)
    8ms
    SHR-1701-III-309: A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer (clinicaltrials.gov)
    P3, N=31, Terminated, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=572 --> 31 | Trial completion date: May 2025 --> Aug 2024 | Recruiting --> Terminated | Trial primary completion date: Mar 2024 --> Aug 2024; Sponsor develops strategy adjustment
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    cisplatin • carboplatin • paclitaxel • retlirafusp alfa (SHR-1701)
    8ms
    SHR-1701-III-307: A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer (clinicaltrials.gov)
    P3, N=737, Active, not recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Trial completion date: Jun 2025 --> Oct 2025 | Trial primary completion date: Mar 2025 --> May 2024
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 overexpression • HER-2 amplification
    |
    capecitabine • oxaliplatin • retlirafusp alfa (SHR-1701)