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    DRUG:

    HRS-4642

    i
    Other names: HRS-4642, HRS 4642, HRS4642, SHR-4642
    Associations

    News

    Trials
    Company:
    Jiangsu Hengrui Pharma
    Drug class:
    KRAS G12D inhibitor
    Related drugs:
    Associations

    News

    Trials
    2d
    Reversal of KRAS G12D inhibitor resistance by nimotuzumab via MEK/ERK-mediated unfolded protein response in pancreatic cancer. (PubMed, Cancer Lett)
    Our findings not only reveal a clinically relevant resistance mechanism to KRAS G12D inhibition but also provide a rational, effective combined strategy. Ultimately, the combination of HRS-4642 with nimotuzumab offers a promising therapeutic strategy for PDAC patients harboring KRAS G12D mutations, laying a foundation for advancing clinical research in overcoming resistance to KRAS G12D-targeted therapies.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D
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    TheraCIM (nimotuzumab) • HRS-4642
    15d
    HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients (clinicaltrials.gov)
    P2, N=133, Recruiting, Zhejiang University | N=32 --> 133
    Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    gemcitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab) • HRS-4642
    21d
    HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=20, Active, not recruiting, West China Hospital | Trial primary completion date: Jan 2027 --> Aug 2026 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial primary completion date
    |
    TheraCIM (nimotuzumab) • HRS-4642
    23d
    Exploratory Clinical Study of HRS-4642 Combined With Adebrelimab in the Treatment of Advanced Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=130, Recruiting, Fudan University | N=35 --> 130 | Trial completion date: Sep 2026 --> Mar 2028 | Trial primary completion date: Jun 2026 --> Jun 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    Avastin (bevacizumab) • CS1002 (ipilimumab biosimilar) • AiRuiLi (adebrelimab) • HRS-4642
    3ms
    Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=134, Not yet recruiting, Fudan University
    New P2 trial
    |
    Erbitux (cetuximab) • capecitabine • oxaliplatin • retlirafusp alfa (SHR-1701) • CS1002 (ipilimumab biosimilar) • HRS-4642
    4ms
    A Phase III Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=30, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    gemcitabine • albumin-bound paclitaxel • HRS-4642
    4ms
    HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation (clinicaltrials.gov)
    P2, N=40, Recruiting, Zhejiang University | Not yet recruiting --> Recruiting | Initiation date: Nov 2025 --> Feb 2026
    Enrollment open • Trial initiation date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    paclitaxel • TheraCIM (nimotuzumab) • HRS-4642
    5ms
    HRS-4642 combined with Nimotuzumab in the treatment of recurrent or metastatic pancreatic ductal adenocarcinoma with KRAS G12D mutation that has failed systemic therapy (ChiCTR2500098420)
    P1/2, N=20, Recruiting, West China Hospital,Sichuan University; West China Hospital,Sichuan University | N=10 --> 20
    Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase) • CA 19-9 (Cancer antigen 19-9)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    TheraCIM (nimotuzumab) • HRS-4642
    5ms
    HRS-4642-206: Phase IB/II clinical study of the safety, tolerability and efficacy of HRS-4642 in combination with other anti-tumor drugs in subjects with solid tumors (ChiCTR2500115250)
    P1/2, N=60, Not yet recruiting, Peking Union Medical College Hospital; Peking Union Medical College Hospital
    New P1/2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    AiRuiLi (adebrelimab) • HRS-4642
    5ms
    HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors (clinicaltrials.gov)
    P1/2, N=60, Recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    gemcitabine • albumin-bound paclitaxel • AiRuiLi (adebrelimab) • HRS-4642
    5ms
    Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=160, Recruiting, Fudan University | Not yet recruiting --> Recruiting | N=120 --> 160
    Enrollment open • Enrollment change
    |
    trastuzumab rezetecan (SHR-A1811) • SHR-A2102 • AiRuiLi (adebrelimab) • HRS-4642 • garetatug rezetecan (SHR-A1904)
    6ms
    HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer (clinicaltrials.gov)
    P2, N=30, Recruiting, Ruijin Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    gemcitabine • albumin-bound paclitaxel • AiRuiLi (adebrelimab) • HRS-4642