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    DRUG CLASS:

    HER3-targeted antibody-drug conjugate

    Related drugs:
    7d
    JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=60, Not yet recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    New P1/2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
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    taragarestrant (D-0502)
    11d
    A study protocol of a single-arm, prospective, open-label, non-controlled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II-IIIB non-small cell lung cancer patients with EGFR mutation. (PubMed, Transl Lung Cancer Res)
    Registered on April 23, 2025. Protocol version: version 2.0, May 06, 2025.
    P2 data • Journal
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    EGFR (Epidermal growth factor receptor)
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    EGFR mutation
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    Ameile (aumolertinib) • izalontamab brengitecan (BL-B01D1)
    21d
    A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P2, N=864, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd.
    New P2 trial
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    Loqtorzi (toripalimab-tpzi) • AWT020
    27d
    CA244-0001: A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=416, Recruiting, Bristol-Myers Squibb | N=238 --> 416 | Trial completion date: Aug 2028 --> Feb 2031 | Trial primary completion date: Dec 2026 --> Feb 2031
    Enrollment change • Trial completion date • Trial primary completion date
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    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tagrisso (osimertinib) • pumitamig (BNT327) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    28d
    ICARUS-BREAST01: Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=139, Recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Active, not recruiting --> Recruiting | N=99 --> 139 | Trial completion date: Apr 2028 --> Apr 2030 | Trial primary completion date: Apr 2025 --> Apr 2027
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    patritumab deruxtecan (U3-1402)
    1m
    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
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    Ameile (aumolertinib) • ruzaltatug rezetecan (SHR-A2009)
    1m
    BL-B01D1-LUNG-101: Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors (clinicaltrials.gov)
    P1, N=470, Recruiting, SystImmune Inc. | N=260 --> 470 | Trial primary completion date: Dec 2025 --> Dec 2026
    Enrollment change • Trial primary completion date
    |
    izalontamab brengitecan (BL-B01D1)
    1m
    A Study of AK138D1 in Advanced Malignant Tumors (clinicaltrials.gov)
    P1, N=200, Recruiting, Akeso
    New P1 trial
    1m
    Patritumab deruxtecan in breast cancer treatment: a drug evaluation. (PubMed, Future Oncol)
    This efficacy has been observed across diverse tumor subtypes and varying levels of HER3 expression. In this review, we will analyze the results of clinical trials investigating HER3-DXd in breast cancer and explore its potential role in future clinical applications and treatment algorithms.
    Review • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
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    patritumab deruxtecan (U3-1402)
    2ms
    Determinants of long-term response to patritumab deruxtecan in breast cancer patient-derived xenografts. (PubMed, NPJ Precis Oncol)
    Basal-like PAM50 intrinsic subtype, limited prior exposure to chemotherapy and intrinsic sensitivity to the TOP1i irinotecan were associated with long-term response. Long-term responders exhibited persistent DNA damage and lacked early transcriptional activation of the G2/M cell cycle checkpoint that allow for DNA repair and RNA-DNA hybrid (R-loop) resolution, in parallel resulting in immune pathways transcriptional activation. Notably, characteristics linked to long-term response were primarily associated with the TOP1i payload activity.
    Journal • BRCA Biomarker • PARP Biomarker
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    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    irinotecan • patritumab deruxtecan (U3-1402)
    2ms
    Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02) (clinicaltrials.gov)
    P1/2, N=180, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jul 2028 --> Dec 2028 | Trial primary completion date: Jul 2028 --> Dec 2028
    Trial completion date • Trial primary completion date • Pan tumor
    |
    patritumab deruxtecan (U3-1402)
    2ms
    BL-B01D1-204-13: A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer (clinicaltrials.gov)
    P2, N=260, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=120 --> 260
    Enrollment change
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • axitinib • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)