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    DRUG:

    trastuzumab pamirtecan (BNT323)

    i
    Other names: BNT323, DB-1303, BNT 323, DB1303, DB 1303, BNT-323
    Company:
    BioNTech, DualityBio
    Drug class:
    Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    1m
    Dynasty-Breast01: A study comparing DB-1303 with T-DM1 in the treatment of HER2-positive unresectable/metastatic breast cancer patients who had previously received trastuzumab and taxane therapy. (clinicaltrials.gov)
    P3, N=228, Active, not recruiting, Yingen Biopharmaceutical (Suzhou) Co., Ltd. | -> Active, not recruiting | Phase classification: PN/A --> P3
    Enrollment closed • Phase classification
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Kadcyla (ado-trastuzumab emtansine) • trastuzumab pamirtecan (BNT323)
    2ms
    BNT323-03: A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P1/2, N=380, Recruiting, BioNTech SE | Trial completion date: May 2029 --> Aug 2029 | Trial primary completion date: May 2028 --> Aug 2029
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Herceptin (trastuzumab) • trastuzumab pamirtecan (BNT323) • pumitamig (BNT327)
    4ms
    BNT323-01: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (clinicaltrials.gov)
    P3, N=480, Recruiting, BioNTech SE
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    paclitaxel • docetaxel • doxorubicin hydrochloride • trastuzumab pamirtecan (BNT323)
    5ms
    BNT323-03: A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P1/2, N=380, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    trastuzumab pamirtecan (BNT323) • pumitamig (BNT327)
    5ms
    A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) (clinicaltrials.gov)
    P3, N=541, Active, not recruiting, DualityBio Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • mTOR (Mechanistic target of rapamycin kinase)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    capecitabine • albumin-bound paclitaxel • trastuzumab pamirtecan (BNT323)
    6ms
    BNT323-01: A clinical study of the anti-cancer effects of an investigational therapy or chemotherapy in patients with recurring uterine cancer (2023-507525-42-00)
    P2/3, N=222, Recruiting, BioNTech SE
    New P2/3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    paclitaxel • trastuzumab pamirtecan (BNT323)
    6ms
    BNT323-03: A clinical study to find the optimal dose of an investigational treatment called BNT323 when used in combination with another investigational treatment, BNT327, and to test if that combination treatment is safe and beneficial for patients with advanced breast cancer (2024-517979-20-00)
    P1/2, N=95, Not yet recruiting, BioNTech SE
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    trastuzumab pamirtecan (BNT323) • pumitamig (BNT327)
    10ms
    Dynasty-Breast01: A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer (clinicaltrials.gov)
    P3, N=228, Active, not recruiting, DualityBio Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Kadcyla (ado-trastuzumab emtansine) • trastuzumab pamirtecan (BNT323)
    1year
    A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P1/2, N=380, Recruiting, BioNTech SE | Trial completion date: Sep 2032 --> May 2029
    Trial completion date
    |
    trastuzumab pamirtecan (BNT323) • pumitamig (BNT327)
    1year
    ENGOT- en25: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (clinicaltrials.gov)
    P3, N=504, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Herceptin (trastuzumab) • paclitaxel • doxorubicin hydrochloride • trastuzumab pamirtecan (BNT323)
    1year
    A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer (clinicaltrials.gov)
    P1/2, N=320, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    trastuzumab pamirtecan (BNT323) • pumitamig (BNT327)
    over1year
    ENGOT- en25: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (clinicaltrials.gov)
    P3, N=504, Not yet recruiting, BioNTech SE | Trial completion date: Aug 2029 --> Jan 2030 | Trial primary completion date: Oct 2027 --> Mar 2028
    Trial completion date • Trial primary completion date
    |
    Herceptin (trastuzumab) • paclitaxel • doxorubicin hydrochloride • trastuzumab pamirtecan (BNT323)