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    DRUG:

    BNT326

    i
    Other names: BNT326, YL202, BNT 326, YL 202, BNT-326, YL-202
    Associations

    News

    Trials
    Company:
    BioNTech, MediLink
    Drug class:
    Topoisomerase I inhibitor, HER3-targeted antibody-drug conjugate
    Related drugs:
    Associations

    News

    Trials
    8d
    BNT326-02: A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P1/2, N=420, Recruiting, BioNTech SE
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • BRAF mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • PD-L1 negative • RET mutation • MET mutation • EGFR negative
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pumitamig (BNT327) • BNT326 • MK-3475 SC
    13d
    BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=980, Recruiting, BioNTech SE | N=329 --> 980
    Enrollment change • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR mutation • HR positive • BRAF mutation • HER-2 negative • EGFR L858R • HER-2 expression • EGFR exon 19 deletion • ALK rearrangement • PD-L1 expression + HER-2 overexpression • HER-2 negative + HR negative
    |
    itraconazole • pumitamig (BNT327) • BNT326
    20d
    Pivotal study to evaluate YL202 versus Docetaxel in Patients with Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer (ChiCTR2600120457)
    P3, N=440, Shanghai Dongfang Hospital; Shanghai Dongfang Hospital
    New P3 trial
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    docetaxel • BNT326
    1m
    BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=280, Recruiting, BioNTech SE
    New P1/2 trial
    |
    itraconazole • pumitamig (BNT327) • BNT326
    1m
    BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=280, Recruiting, BioNTech SE | N=172 --> 280
    Enrollment change
    |
    itraconazole • pumitamig (BNT327) • BNT326
    2ms
    YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=376, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • Trodelvy (sacituzumab govitecan-hziy) • BNT326
    2ms
    A Study of YL202 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=100, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BNT326
    3ms
    Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=440, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P3 trial
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    docetaxel • BNT326
    3ms
    BNT326-01: A clinical study to test if an investigational treatment called BNT326 is safe and potentially beneficial when used alone or in combination with other investigational treatments such as BNT327, for people with advanced malignant tumors (2024-517261-16-00)
    P1/2, N=172, Recruiting, BioNTech SE
    New P1/2 trial
    |
    pumitamig (BNT327) • BNT326
    3ms
    BNT326-02: A clinical trial to test if an investigational combination therapy with BNT326 and BNT327 is safe and potentially beneficial for people with advanced non-small cell lung cancer (NSCLC) (2024-519344-32-00)
    P1/2, N=88, Not yet recruiting, BioNTech SE
    New P1/2 trial
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • pumitamig (BNT327) • BNT326
    7ms
    BNT326-02: A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P1/2, N=420, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pumitamig (BNT327) • BNT326 • MK-3475 SC
    7ms
    A Study of YL202 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P2 trial
    |
    BNT326