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    DRUG:

    ruzaltatug rezetecan (SHR-A2009)

    i
    Other names: SHR-A2009, SHRA2009, SHR A2009
    Associations

    News

    Trials
    Company:
    Jiangsu Hengrui Pharma
    Drug class:
    Topoisomerase I inhibitor, HER3-targeted antibody-drug conjugate
    Related drugs:
    Associations

    News

    Trials
    1m
    A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=156, Recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd. | Trial completion date: Jun 2027 --> Dec 2029 | Trial primary completion date: Jun 2026 --> Jun 2029
    Trial completion date • Trial primary completion date
    |
    carboplatin • paclitaxel • pemetrexed • Ameile (aumolertinib) • AiRuiLi (adebrelimab) • ruzaltatug rezetecan (SHR-A2009) • tizetatug rezetecan (SHR-A1921)
    1m
    A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=156, Recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    carboplatin • paclitaxel • pemetrexed • Ameile (aumolertinib) • AiRuiLi (adebrelimab) • ruzaltatug rezetecan (SHR-A2009) • tizetatug rezetecan (SHR-A1921)
    3ms
    A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=498, Active, not recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • carboplatin • ruzaltatug rezetecan (SHR-A2009)
    3ms
    Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=160, Recruiting, Fudan University | N=120 --> 160
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HR positive
    |
    trastuzumab rezetecan (SHR-A1811) • famitinib (SHR 1020) • SHR-A2102 • bulumtatug fuvedotin (9MW2821) • ruzaltatug rezetecan (SHR-A2009) • tizetatug rezetecan (SHR-A1921)
    4ms
    A Phase Ib Study of HS-10504 Combined Therapy in NSCLC (clinicaltrials.gov)
    P1, N=400, Not yet recruiting, Jiangsu Hansoh Pharmaceutical Co., Ltd.
    New P1 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    SHR-A2102 • PM1080 • ruzaltatug rezetecan (SHR-A2009)
    6ms
    A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=576, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Ameile (aumolertinib) • ruzaltatug rezetecan (SHR-A2009)
    9ms
    A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=576, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    New P3 trial
    |
    Ameile (aumolertinib) • ruzaltatug rezetecan (SHR-A2009)
    over1year
    A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=500, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • carboplatin • ruzaltatug rezetecan (SHR-A2009)
    over1year
    SHR-A2009-I-102: The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=19, Completed, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Apr 2024 | Trial primary completion date: Jun 2025 --> Apr 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    ruzaltatug rezetecan (SHR-A2009)
    over1year
    Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=350, Recruiting, Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab) • ruzaltatug rezetecan (SHR-A2009)
    over1year
    A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=500, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    New P3 trial • Metastases
    |
    cisplatin • carboplatin • ruzaltatug rezetecan (SHR-A2009)
    over1year
    Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=120, Recruiting, Fudan University
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • NECTIN4 (Nectin Cell Adhesion Molecule 4) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    HER-2 expression
    |
    trastuzumab rezetecan (SHR-A1811) • SHR-A2102 • ruzaltatug rezetecan (SHR-A2009) • tizetatug rezetecan (SHR-A1921)