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    DRUG:

    Aidixi (disitamab vedotin)

    i
    Other names: RC48, RC48-ADC, RC 48-ADC, RC 48, RC-48, RC-48-ADC
    Company:
    Pfizer, Rongchang Pharma
    Drug class:
    Microtubule inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    4d
    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
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Tyvyt (sintilimab) • capecitabine • Aidixi (disitamab vedotin)
    5d
    DTP-HER2: A Study of Disitamab Vedotin, Tunlametinib, and PD-1 Antibody for Advanced Gastric Cancer (clinicaltrials.gov)
    P2, N=76, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Tevimbra (tislelizumab-jsgr) • Aidixi (disitamab vedotin) • Kolupin (tunlametinib)
    5d
    Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov)
    P2, N=39, Recruiting, Peking Union Medical College | Trial primary completion date: Jul 2026 --> Jul 2028
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    carboplatin • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Piqray (alpelisib) • Irene (pyrotinib) • albumin-bound paclitaxel • abiraterone acetate • fulvestrant • Aidixi (disitamab vedotin) • exemestane • Padcev (enfortumab vedotin-ejfv) • bicalutamide • Kaitanni (cadonilimab) • goserelin acetate • Qibeian (iparomlimab/tuvonralimab) • Yidafan (ivonescimab) • iparomlimab (QL1604) • leuprolide acetate for depot suspension • Entyvio (vedolizumab)
    11d
    LUXUS41: Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=192, Not yet recruiting, Peking University First Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    carboplatin • gemcitabine • Aidixi (disitamab vedotin)
    14d
    A Real-World, Single-Arm Study Protocol of Disitamab Vedotin in Combination With Immunotherapy and Multimodal Radiation Therapy for HER2-Positive Advanced Gastric Cancer: After Second-Line Treatment Failure (clinicaltrials.gov)
    P=N/A, N=30, Not yet recruiting, West China Hospital
    New trial • Real-world evidence • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Tyvyt (sintilimab) • Aidixi (disitamab vedotin)
    22d
    Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial (clinicaltrials.gov)
    P2, N=124, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 expression
    |
    oxaliplatin • Aidixi (disitamab vedotin)
    22d
    Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Patients With MIBC (clinicaltrials.gov)
    P2, N=146, Not yet recruiting, chenxu
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin) • Cdactin-O (CBM588)
    26d
    Evaluation of RC48-ADC in Combination with PRaG Regimen: An Open-Label, Prospective, Multicentre Study Assessing Efficacy and Safety for Advanced Refractory HER2-Expressing Solid Tumors (PRaG3.0 Study Protocol). (PubMed, Technol Cancer Res Treat)
    Planned enrollment is 62 patients.ConclusionThe PRaG3.0 protocol represents an innovative approach combining ADC therapy with radioimmunotherapy to address HER2-expressing cancers, including those with HER2-low expression. If successful, this regimen could establish a highly effective combination strategy.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • IL2 (Interleukin 2) • CSF2 (Colony stimulating factor 2)
    |
    HER-2 expression • HER-2 underexpression
    |
    Aidixi (disitamab vedotin)
    27d
    DAWN trial: a prospective, multicenter, single-arm phase II study of neoadjuvant disitamab vedotin (RC48) in combination with adebrelimab, apatinib, and S-1 for locally advanced HER2-positive gastric cancer. (PubMed, J Gastrointest Oncol)
    We hypothesize that the combination of these four therapeutic strategies could significantly enhance treatment efficacy in HER2-positive gastric cancer, particularly in combined positive score (CPS) PD-L1-negative patients. This study was registered at ClinicalTrials.gov (Identifier: NCT06385873).
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    PD-L1 expression • HER-2 positive • HER-2 expression • PD-L1 negative • EGFR positive
    |
    AiTan (rivoceranib) • Aidixi (disitamab vedotin) • AiRuiLi (adebrelimab)
    28d
    A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2/3, N=700, Not yet recruiting, RemeGen Co., Ltd.
    New P2/3 trial
    |
    Avastin (bevacizumab) • capecitabine • oxaliplatin • Aidixi (disitamab vedotin)
    1m
    A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P1, N=121, Active, not recruiting, RemeGen Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    carboplatin • paclitaxel • pemetrexed • Aidixi (disitamab vedotin)
    1m
    Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study (clinicaltrials.gov)
    P2, N=37, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Avastin (bevacizumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Aidixi (disitamab vedotin)