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    DRUG CLASS:

    HER2-targeted antibody-drug conjugate

    Related drugs:
    1d
    ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors (clinicaltrials.gov)
    P=N/A, N=140, Completed, AstraZeneca | Recruiting --> Completed | N=105 --> 140
    Trial completion • Enrollment change
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden)
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    MSI-H/dMMR • BRAF mutation • HER-2 expression • BRAF wild-type • RAS wild-type • HER-2 positive + RAS wild-type
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    Enhertu (fam-trastuzumab deruxtecan-nxki)
    1d
    EPOC2003: Phase 2 Study of Trastuzumab Deruxtecan in the Neoadjuvant Treatment, or Trastuzumab Deruxtecan Plus Capecitabine Plus Durvalumab(MEDI4736) in the Preoperative and Postoperative Adjuvant Treatment for Patients With HER2 Positive Gastric and Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=64, Active, not recruiting, National Cancer Center Hospital East | Recruiting --> Active, not recruiting
    Enrollment closed
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 overexpression
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    Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine
    1d
    A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HER-2 expression
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    trastuzumab brengitecan (BL-M07D1)
    1d
    A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=596, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive
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    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • trastuzumab brengitecan (BL-M07D1)
    2d
    Potency and safety of novel [225Ac]Ac-labeled pertuzumab-PEGylated emtansine drug conjugate against HER2-positive breast cancer. (PubMed, Br J Cancer)
    [225Ac]Ac-Macropa-pertuzumab-PEG6-DM1 is more potent than pertuzumab-PEG6-DM1 against trastuzumab or T-DM1-resistant BC necessitating clinical investigation.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HER-2 overexpression • HER-2 amplification • EGFR positive
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    Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine)
    2d
    Clinical Effectiveness and Safety of SHR-A1811 in Chinese Patients With HER2-Altered NSCLC (clinicaltrials.gov)
    P=N/A, N=1000, Not yet recruiting, Nanjing Tianyinshan Hospital
    New trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    trastuzumab rezetecan (SHR-A1811)
    2d
    A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Pfizer
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA (Breast cancer early onset)
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    HER-2 expression • BRCA mutation • PD-L1 expression + HER-2 overexpression
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    Aidixi (disitamab vedotin)
    4d
    Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=178, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
    New P1/2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HER-2 expression • HER-2 underexpression
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    TQB2102 • TQB2930
    6d
    ERBB2 activating mutations and co-occurring genomic alterations contribute to disease heterogeneity in patients with ERBB2-mutant lung cancer. (PubMed, J Thorac Oncol)
    NSCLCs harboring ECD-ERBB2 mutations are associated with a unique clinico-genomic phenotype and improved outcomes with first-line chemoimmunotherapy. These findings have implications for optimizing treatment strategies in this disease.
    Journal • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • RBM10 (RNA Binding Motif Protein 10)
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    KRAS mutation • EGFR mutation • PIK3CA mutation • HER-2 mutation • STK11 mutation • KEAP1 mutation
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    Enhertu (fam-trastuzumab deruxtecan-nxki) • Hernexeos (zongertinib) • Hyrnuo (sevabertinib)
    6d
    Emerging treatment strategies for HER2-mutant NSCLC: Striving for selectivity, efficacy, and tolerability. (PubMed, Lung Cancer)
    Currently, no first-line HER2-directed agents are available and, until recently, trastuzumab deruxtecan, a HER2-targeting antibody-drug conjugate, was the only approved HER2-directed treatment option in the previously treated setting. In the current review, we summarize the development of treatment options for HER2-mutant NSCLC, including antibody-drug conjugates and tyrosine kinase inhibitors.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    6d
    Sequential Use of Trastuzumab Deruxtecan and Sacituzumab Govitecan in Patients with Breast Cancer: A Pharmacological Approach to Support the Clinical Rationale. (PubMed, Drugs)
    By contrast, sacituzumab govitecan is a TROP-2-targeted ADC conjugated through a hydrolysable CL2A linker to SN-38, the active metabolite of irinotecan. Clinically, trastuzumab deruxtecan has shown substantial efficacy in both HER2-positive and HER2-low breast cancer, whereas sacituzumab govitecan has demonstrated efficacy across triple-negative and hormone receptor-positive/HER2-negative breast cancers. Collectively, these agents highlight how variations in target antigen, linker chemistry, and payload potency impact ADC activity, therapeutic index, and potential strategies for sequential treatment in advanced breast cancer.
    Review • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • SLX4 (SLX4 Structure-Specific Endonuclease Subunit) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
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    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
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    Enhertu (fam-trastuzumab deruxtecan-nxki) • irinotecan • Trodelvy (sacituzumab govitecan-hziy)
    7d
    Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Locally Advanced HER2-expressing Rectal Cance (clinicaltrials.gov)
    P2, N=29, Not yet recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Tyvyt (sintilimab) • capecitabine • Aidixi (disitamab vedotin)