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    DRUG:

    SYS6010

    i
    Other names: CPO-301, SYS 6010, SYS-6010, SYS6010, CPO301, CPO 301
    Associations

    News

    Trials
    Company:
    CSPC Pharma
    Drug class:
    Topoisomerase I inhibitor, EGFR-targeted antibody-drug conjugate
    Related drugs:
    Associations

    News

    Trials
    3d
    SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=500, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    ALK fusion
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    cisplatin • carboplatin • paclitaxel • Tevimbra (tislelizumab-jsgr) • pemetrexed • Enshuxing (enlonstobart) • SYS6010
    29d
    SYNSTAR-02: A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=680, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd. | N=450 --> 680 | Initiation date: Mar 2026 --> Jun 2026
    Enrollment change • Trial initiation date
    |
    EGFR (Epidermal growth factor receptor)
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    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • SYS6010
    3ms
    CPO301-US-101: A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=132, Recruiting, Conjupro Biotherapeutics, Inc. | Trial completion date: Dec 2025 --> Aug 2027 | Trial primary completion date: Jun 2025 --> May 2027
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    EGFR mutation • KRAS wild-type • RAS wild-type
    |
    SYS6010
    3ms
    SYS6090 Combination Therapy in Advanced Lung Cancer (clinicaltrials.gov)
    P1/2, N=596, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P1/2 trial
    |
    Avastin (bevacizumab) • paclitaxel • docetaxel • pemetrexed • etoposide IV • SYS6010
    3ms
    SYNSTAR03: SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ (clinicaltrials.gov)
    P3, N=686, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR expression • EGFR wild-type
    |
    docetaxel • SYS6010
    4ms
    SYS6010 Versus Chemotherapy in Locally Advanced or Metastatic/Recurrent Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=436, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
    New P3 trial
    |
    EGFR expression
    |
    paclitaxel • docetaxel • irinotecan • SYS6010
    4ms
    A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=400, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative • EGFR expression • EGFR positive • EGFR negative
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    gemcitabine • capecitabine • eribulin mesylate • vinorelbine tartrate • SYS6010
    4ms
    An open-label, multicenter, phase II study to evaluate the efficacy and safety of SYS6010 combined with enlonstobart in the recurrent or metastatic head and neck squamous cell carcinoma (ChiCTR2500112871)
    P2, N=70, Not yet recruiting, Shanghai East Hospital, Tongji University(Shanghai East Hospital); Shanghai East Hospital, Tongji University(Shanghai East Hospital)
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
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    Enshuxing (enlonstobart) • SYS6010
    4ms
    Phase II/III Trial of SYS6010 plus Enlonstobart Injection ± Chemotherapy in Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ChiCTR2500112440)
    P2/3, N=737, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P2/3 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    EGFR expression
    |
    cisplatin • paclitaxel • 5-fluorouracil • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • capecitabine • leucovorin calcium • Enshuxing (enlonstobart) • SYS6010
    4ms
    A Study of SYS6010 Combined with Osimertinib versus Osimertinib alone as Neoadjuvant Therapy for Patients with EGFRm Resectable Non-squamous Non-small Cell Lung Cancer (ChiCTR2500113154)
    P2, N=120, Not yet recruiting, Shanghai Chest Hospital; Shanghai Pulmonary Hospital; CSPC Megalith Biopharmaceutical Co., Ltd
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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    Tagrisso (osimertinib) • SYS6010 • simmitinib (SYHA1817)
    4ms
    A phase Ib/II clinical trial on the safety and efficacy of sirolimus (albumin-bound) combined with different ADCs in patients with advanced solid tumors (ChiCTR2500111937)
    P1, N=444, Not yet recruiting, Fudan University Shanghai Cancer Center; CSPC Zhongqi Pharmaceutical Technology Co., Ltd.
    New P1 trial
    |
    EGFR (Epidermal growth factor receptor) • CD276 (CD276 Molecule) • NECTIN4 (Nectin Cell Adhesion Molecule 4)
    |
    HER-2 negative • HER-2 expression • EGFR expression
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    sirolimus • trastuzumab envedotin (DP303c) • SYS6010 • sirolimus for injection (albumin-bound) (SRL-HSA)
    4ms
    SYNSTAR-02: A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=450, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • SYS6010 • simmitinib (SYHA1817)