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    DRUG:

    trastuzumab pamirtecan (BNT323)

    i
    Company:
    BioNTech, DualityBio
    Drug class:
    Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    9d
    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)
    2ms
    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=532, Recruiting, DualityBio Inc. | Trial primary completion date: Dec 2025 --> May 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression • PGR positive
    |
    capecitabine • albumin-bound paclitaxel • trastuzumab pamirtecan (BNT323)
    2ms
    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, Not yet recruiting, BioNTech SE
    New P1/2 trial
    |
    trastuzumab pamirtecan (BNT323) • BNT327
    2ms
    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=468, Not yet recruiting, BioNTech SE | Trial completion date: Mar 2029 --> Aug 2029 | Initiation date: Jan 2025 --> Jun 2025 | Trial primary completion date: May 2027 --> Oct 2027
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    paclitaxel • doxorubicin hydrochloride • trastuzumab pamirtecan (BNT323)
    7ms
    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=468, Not yet recruiting, BioNTech SE | Trial completion date: Dec 2028 --> Mar 2029 | Initiation date: Aug 2024 --> Nov 2024
    Trial completion date • Trial initiation date
    |
    paclitaxel • doxorubicin hydrochloride • trastuzumab pamirtecan (BNT323)
    8ms
    A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=766, Recruiting, DualityBio Inc. | Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Jun 2025 --> Apr 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Perjeta (pertuzumab) • trastuzumab pamirtecan (BNT323) • itraconazole • ritonavir
    11ms
    A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (clinicaltrials.gov)
    P3, N=468, Not yet recruiting, BioNTech SE | Trial completion date: Aug 2028 --> Dec 2028 | Initiation date: Apr 2024 --> Aug 2024 | Trial primary completion date: Oct 2026 --> Feb 2027
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    paclitaxel • doxorubicin hydrochloride • trastuzumab pamirtecan (BNT323)
    1year
    A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (clinicaltrials.gov)
    P3, N=468, Not yet recruiting, BioNTech SE
    New P3 trial
    |
    paclitaxel • doxorubicin hydrochloride • trastuzumab pamirtecan (BNT323)
    1year
    A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer (clinicaltrials.gov)
    P3, N=224, Recruiting, DualityBio Inc.
    New P3 trial • Metastases
    |
    Kadcyla (ado-trastuzumab emtansine) • trastuzumab pamirtecan (BNT323)
    1year
    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=532, Recruiting, DualityBio Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression • PGR positive
    |
    capecitabine • albumin-bound paclitaxel • trastuzumab pamirtecan (BNT323)
    over1year
    A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=631, Recruiting, DualityBio Inc. | N=463 --> 631
    Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Perjeta (pertuzumab) • trastuzumab pamirtecan (BNT323) • itraconazole • ritonavir
    over1year
    A Study of DB-1303 vs Investigator's Choice Chemotherapy in Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=466, Not yet recruiting, DualityBio Inc.
    New P3 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression • PGR positive
    |
    capecitabine • albumin-bound paclitaxel • trastuzumab pamirtecan (BNT323)
    over1year
    DB-1303, A HER2-Targeting ADC, For Patients With Advanced/Metastatic Endometrial Cancer: Preliminary Clinical Results From An Ongoing Phase 1/2a Trial (NCT05150691) (ESGO 2023)
    No interstitial lung disease occurred. Conclusion DB-1303 demonstrated a manageable safety profile and promising antitumor activity, with high disease control in patients with advanced/metastatic EC.
    Clinical • P1/2 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    trastuzumab pamirtecan (BNT323)
    2years
    Preclinical pharmacokinetics in cynomolgus monkeys and first in human dose prediction of DB-1303, a HER2-targeting antibody-drug conjugate (AACR 2023)
    DB-1303 exhibited favorable PK characteristics of DB-1303 in cynomolgus monkeys, and is predicted to have large safety margins at the selected doses in the first in human study. At the time of presentation, the first-in-human phase 1/2 study in patients with advanced solid tumors is in progress (NCT05150691).
    P1 data • PK/PD data • Preclinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    trastuzumab pamirtecan (BNT323)
    over2years
    A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=360, Recruiting, DualityBio Inc. | N=180 --> 360
    Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    trastuzumab pamirtecan (BNT323)
    over2years
    DB-1303, a HER2-targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising safety profile and anti-tumor efficacy with differentiation from DS-8201a (AACR-NCI-EORTC 2022)
    l In vivo, DB-1303 induced dose-dependent tumor growth inhibition and tumor regression in T-DM1-resistant JIMT-1 xenograft model, HER2 low-expressing Ishikawa xenograft and two HER2-low breast cancer PDX models. At the time of presentation, a first-in-human phase 1/2 study in patients with advanced solid tumors is in progress (NCT05150691). No
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • HER-2 expression • HER-2 underexpression
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • trastuzumab pamirtecan (BNT323)
    3years
    A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=140, Recruiting, DualityBio Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    trastuzumab pamirtecan (BNT323)
    over3years
    A Study of DB-1303 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=140, Not yet recruiting, DualityBio Inc.
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    trastuzumab pamirtecan (BNT323)