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    DRUG:

    Aidixi (disitamab vedotin)

    i
    Company:
    Pfizer, Rongchang Pharma
    Drug class:
    Microtubule inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    Apply
    A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 (KEYNOTE-D78) (NCT04879329)
    Phase 2
    Seagen Inc.
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    05/03/2022
    Primary completion :
    11/30/2026
    Completion :
    05/30/2028
    HER-2
    |
    HER-2 expression
    |
    Keytruda (pembrolizumab) • Aidixi (disitamab vedotin)
    Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 (KEYNOTE-D74) (NCT05911295)
    Phase 3
    Seagen Inc.
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    09/22/2023
    Primary completion :
    06/30/2026
    Completion :
    04/30/2029
    HER-2
    |
    HER-2 expression
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • Aidixi (disitamab vedotin)
    First-line Treatment with RC48 Plus Tislelizumab and S-1(RCTS) in Advanced Gastric Cancer (NCT05586061)
    Phase 2
    Qilu Hospital of Shandong University
    Active, not recruiting
    Last update posted :
    02/07/2025
    Initiation :
    02/10/2023
    Primary completion :
    12/29/2024
    Completion :
    12/31/2025
    HER-2
    |
    Tevimbra (tislelizumab-jsgr) • Aidixi (disitamab vedotin) • Teysuno (gimeracil/oteracil/tegafur)
    A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2 (SGNDV-005) (NCT06003231)
    Phase 2
    Seagen Inc.
    Active, not recruiting
    Last update posted :
    02/07/2025
    Initiation :
    11/14/2023
    Primary completion :
    05/31/2026
    Completion :
    05/31/2028
    HER-2
    |
    HER-2 expression
    |
    Aidixi (disitamab vedotin)
    A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors (NCT06038396)
    Phase 1/2
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    01/29/2025
    Initiation :
    08/03/2023
    Primary completion :
    02/28/2026
    Completion :
    08/31/2026
    CLDN18
    |
    CLDN1 positive
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin) • ciletatug vedotin (RC118)
    Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer (neovision) (NCT06734182)
    Phase 2
    Guangdong Provincial People's Hospital
    Recruiting
    Last update posted :
    12/16/2024
    Initiation :
    06/22/2024
    Primary completion :
    06/22/2027
    Completion :
    06/22/2028
    HER-2
    |
    PD-L1 expression • HER-2 expression
    |
    carboplatin • Aidixi (disitamab vedotin) • Enweida (envafolimab)
    Disitamab Vedotin (RC48) in Combination With AK104 (PD-1/CTLA-4 Bispecific) and Bevacizumab for the Treatment of Recurrent and Persistent Clear Cell Ovarian Cancer: a Single-arm, Phase II, Multicenter Study (DAB OCC Study) (NCT06540729)
    Phase 2
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Un...
    Not yet recruiting
    Last update posted :
    08/06/2024
    Initiation :
    07/31/2024
    Primary completion :
    08/01/2028
    Completion :
    08/01/2030
    MSI
    |
    Avastin (bevacizumab) • Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    Disitamab Vedotin Combined With Fruquintinib for mCRC With HER2 Expression (HCCSC-C03) (NCT05661357)
    Phase 4
    Zhongnan Hospital
    Active, not recruiting
    Last update posted :
    04/17/2024
    Initiation :
    01/01/2023
    Primary completion :
    01/31/2025
    Completion :
    12/31/2025
    HER-2
    |
    HER-2 amplification • HER-2 mutation • HER-2 expression
    |
    Aidixi (disitamab vedotin) • Fruzaqla (fruquintinib)
    Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer (NCT06105008)
    Phase 2
    RemeGen Co., Ltd.
    Not yet recruiting
    Last update posted :
    02/21/2024
    Initiation :
    12/20/2024
    Primary completion :
    12/20/2025
    Completion :
    04/10/2026
    HER-2 • ER
    |
    HER-2 expression • HER-2 underexpression • PGR expression
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression) (NCT05135715)
    Phase 2
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    02/20/2024
    Initiation :
    04/19/2022
    Primary completion :
    12/30/2024
    Completion :
    12/30/2025
    HER-2
    |
    Aidixi (disitamab vedotin)
    A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer (NCT05297552)
    Phase 2
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    02/20/2024
    Initiation :
    05/26/2022
    Primary completion :
    06/01/2024
    Completion :
    02/28/2025
    HER-2
    |
    HER-2 expression
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases (NCT03500380)
    Phase 2/3
    RemeGen Co., Ltd.
    Active, not recruiting
    Last update posted :
    02/20/2024
    Initiation :
    04/24/2018
    Primary completion :
    07/31/2024
    Completion :
    12/31/2024
    HER-2
    |
    HER-2 positive • HER-2 expression
    |
    lapatinib • capecitabine • Aidixi (disitamab vedotin)
    RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2 (NCT05403242)
    Phase 1/2
    Chinese PLA General Hospital
    Recruiting
    Last update posted :
    01/08/2024
    Initiation :
    09/20/2022
    Primary completion :
    09/01/2025
    Completion :
    09/01/2026
    HER-2
    |
    Aidixi (disitamab vedotin) • Teysuno (gimeracil/oteracil/tegafur)
    RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations (NCT06185400)
    Phase 2
    Cancer Institute and Hospital, Chinese Academy ...
    Not yet recruiting
    Last update posted :
    12/29/2023
    Initiation :
    02/01/2024
    Primary completion :
    07/01/2025
    Completion :
    12/01/2026
    HER-2
    |
    Tagrisso (osimertinib) • Irene (pyrotinib) • Ameile (aumolertinib) • Aidixi (disitamab vedotin) • Ivesa (firmonertinib)
    A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression (NCT04714190)
    Phase 3
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    12/21/2023
    Initiation :
    03/24/2021
    Primary completion :
    12/01/2024
    Completion :
    06/30/2025
    HER-2
    |
    HER-2 overexpression
    |
    paclitaxel • AiTan (rivoceranib) • irinotecan • Aidixi (disitamab vedotin)
    A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer (NCT04329429)
    Phase 2
    RemeGen Co., Ltd.
    Active, not recruiting
    Last update posted :
    12/20/2023
    Initiation :
    08/24/2020
    Primary completion :
    11/03/2023
    Completion :
    06/30/2024
    HER-2
    |
    HER-2 overexpression
    |
    Aidixi (disitamab vedotin)
    A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma (NCT05302284)
    Phase 3
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    12/18/2023
    Initiation :
    06/14/2022
    Primary completion :
    12/31/2026
    Completion :
    04/30/2028
    HER-2
    |
    HER-2 expression
    |
    cisplatin • carboplatin • gemcitabine • Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer (NCT04073602)
    Phase 2
    RemeGen Co., Ltd.
    Completed
    Last update posted :
    12/18/2023
    Initiation :
    08/19/2019
    Primary completion :
    09/30/2022
    Completion :
    01/31/2023
    HER-2
    |
    HER-2 negative
    |
    cisplatin • Aidixi (disitamab vedotin)
    A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer (NCT04311034)
    Phase 1/2
    RemeGen Co., Ltd.
    Completed
    Last update posted :
    12/18/2023
    Initiation :
    09/26/2018
    Primary completion :
    12/21/2021
    Completion :
    05/30/2022
    HER-2 • MET
    |
    EGFR mutation • HER-2 overexpression • HER-2 mutation • MET amplification • EGFR T790M • MET mutation • HER-2 exon 20 mutation
    |
    Aidixi (disitamab vedotin)
    To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG) (NCT05514158)
    Phase 1
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    12/18/2023
    Initiation :
    09/28/2022
    Primary completion :
    05/30/2024
    Completion :
    09/30/2024
    HER-2
    |
    Aidixi (disitamab vedotin) • RC98
    A Study of RC48-ADC for the Treatment of HER2-expressing Gynecological Malignancies (NCT04965519)
    Phase 2
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    12/18/2023
    Initiation :
    12/21/2021
    Primary completion :
    10/01/2024
    Completion :
    06/01/2025
    HRD • BRCA • MUC16
    |
    HER-2 expression • HRD • BRCA mutation
    |
    Aidixi (disitamab vedotin)
    RC48 Plus Tislelizumab, Low-dose Capecitabine and Celecoxib for HER2-positive Metastatic Colorectal Cancer (DETECT) (NCT05578287)
    Phase 2
    Sun Yat-sen University
    Recruiting
    Last update posted :
    12/07/2023
    Initiation :
    07/18/2023
    Primary completion :
    12/15/2024
    Completion :
    12/25/2025
    HER-2
    |
    HER-2 positive
    |
    Tevimbra (tislelizumab-jsgr) • capecitabine • Aidixi (disitamab vedotin) • celecoxib oral
    A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer (NCT05980481)
    Phase 2/3
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    11/29/2023
    Initiation :
    08/04/2023
    Primary completion :
    07/10/2024
    Completion :
    07/10/2025
    HER-2
    |
    HER-2 expression
    |
    Herceptin (trastuzumab) • Loqtorzi (toripalimab-tpzi) • capecitabine • oxaliplatin • Aidixi (disitamab vedotin)
    A Study of RC148 in Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (NCT06016062)
    Phase 1
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    11/29/2023
    Initiation :
    09/14/2023
    Primary completion :
    12/31/2024
    Completion :
    12/31/2025
    PD-1
    |
    Aidixi (disitamab vedotin)
    A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation (NCT05745740)
    Phase 1/2
    RemeGen Co., Ltd.
    Not yet recruiting
    Last update posted :
    11/27/2023
    Initiation :
    04/01/2024
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    HER-2
    |
    HER-2 mutation • HER-2 exon 20 insertion • HER-2 exon 20 mutation • HER-2 exon 23 mutation
    |
    Irene (pyrotinib) • Aidixi (disitamab vedotin)
    RC48-ADC Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression (NCT05940896)
    Phase 1
    RemeGen Co., Ltd.
    Recruiting
    Last update posted :
    11/27/2023
    Initiation :
    06/29/2023
    Primary completion :
    11/16/2024
    Completion :
    02/28/2027
    HER-2
    |
    HER-2 expression
    |
    Aidixi (disitamab vedotin)
    A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer (RC48-C009) (NCT03809013)
    Phase 2
    RemeGen Co., Ltd.
    Completed
    Last update posted :
    11/27/2023
    Initiation :
    01/07/2019
    Primary completion :
    03/04/2021
    Completion :
    06/05/2023
    HER-2
    |
    HER-2 overexpression
    |
    cisplatin • Aidixi (disitamab vedotin)
    Posterior-line Treatment With Disitamab Vedotin Plus PD-1 in Advanced HER2-low Expressing Gastric Cancer (NCT06078982)
    Phase 1
    Shanghai East Hospital
    Recruiting
    Last update posted :
    10/12/2023
    Initiation :
    06/06/2023
    Primary completion :
    08/01/2025
    Completion :
    08/01/2025
    HER-2
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC) (NCT05837806)
    Phase 2
    Tianjin Medical University Second Hospital
    Recruiting
    Last update posted :
    10/12/2023
    Initiation :
    12/30/2022
    Primary completion :
    11/30/2024
    Completion :
    12/30/2027
    HER-2 • PD-L1 • TMB
    |
    PD-L1 expression • HER-2 mutation • HER-2 expression
    |
    Tevimbra (tislelizumab-jsgr) • Aidixi (disitamab vedotin)
    A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer (NCT06074484)
    Phase 2
    Cancer Institute and Hospital, Chinese Academy ...
    Recruiting
    Last update posted :
    10/10/2023
    Initiation :
    09/10/2023
    Primary completion :
    08/10/2024
    Completion :
    08/10/2025
    HER-2
    |
    HER-2 expression
    |
    Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With HER2 IHC2+/3+ ESCC (NCT06055153)
    Phase 1/2
    Changhai Hospital
    Not yet recruiting
    Last update posted :
    09/26/2023
    Initiation :
    09/30/2023
    Primary completion :
    02/28/2025
    Completion :
    04/30/2025
    HER-2
    |
    cisplatin • AiRuiKa (camrelizumab) • Aidixi (disitamab vedotin)
    RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression (NCT05957757)
    Phase 2
    RenJi Hospital
    Recruiting
    Last update posted :
    08/31/2023
    Initiation :
    08/05/2023
    Primary completion :
    06/08/2026
    Completion :
    06/08/2026
    HER-2
    |
    HER-2 expression
    |
    Tevimbra (tislelizumab-jsgr) • Aidixi (disitamab vedotin)
    Efficacy and Safety of Disitamab Vedotin Plus Pyrotinib or Naratinib in HER2-positive Breast Cancer Patients With Brain Metastasis (NCT06015113)
    Phase N/A
    Xi'an International Medical Center Hospital
    Not yet recruiting
    Last update posted :
    08/29/2023
    Initiation :
    09/01/2023
    Primary completion :
    04/01/2026
    Completion :
    04/01/2027
    HER-2
    |
    HER-2 positive
    |
    Irene (pyrotinib) • Aidixi (disitamab vedotin)
    JS001 in Combination With RC48-ADC in Treatment of HER2-Positive Advanced Malignant Solid Tumors (NCT04280341)
    Phase 1
    Peking University
    Recruiting
    Last update posted :
    08/25/2023
    Initiation :
    06/03/2020
    Primary completion :
    12/01/2024
    Completion :
    12/01/2024
    HER-2
    |
    HER-2 positive
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer (NCT06000033)
    Phase 2
    Qilu Hospital of Shandong University
    Not yet recruiting
    Last update posted :
    08/21/2023
    Initiation :
    08/10/2023
    Primary completion :
    12/31/2024
    Completion :
    12/31/2025
    HER-2
    |
    HER-2 expression
    |
    Focus V (anlotinib) • Aidixi (disitamab vedotin)
    RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer (NCT05996952)
    Phase 2
    West China Hospital
    Not yet recruiting
    Last update posted :
    08/17/2023
    Initiation :
    08/01/2023
    Primary completion :
    08/01/2025
    Completion :
    08/01/2026
    HER-2
    |
    HER-2 expression
    |
    Aidixi (disitamab vedotin)
    Disitamab Vedotin, Fruquintinib and Tislelizumab in Second-line Treatment for HER2-positive MGC (NCT05982834)
    Phase 1/2
    Fudan University
    Recruiting
    Last update posted :
    08/09/2023
    Initiation :
    05/09/2023
    Primary completion :
    05/01/2025
    Completion :
    12/01/2025
    HER-2
    |
    Tevimbra (tislelizumab-jsgr) • Aidixi (disitamab vedotin) • Fruzaqla (fruquintinib)
    Clinical Study on the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC) (NCT05955209)
    Phase 2
    Peking University Cancer Hospital & Institute
    Not yet recruiting
    Last update posted :
    07/21/2023
    Initiation :
    08/01/2023
    Primary completion :
    08/01/2024
    Completion :
    08/01/2025
    HER-2
    |
    Aidixi (disitamab vedotin)
    Efficacy and Safety of Disitamab Vedotin Combined With Sintilimab (NCT05928897)
    Phase 2
    Xiangya Hospital of Central South University
    Not yet recruiting
    Last update posted :
    07/04/2023
    Initiation :
    07/01/2023
    Primary completion :
    07/01/2025
    Completion :
    07/01/2025
    HER-2
    |
    HER-2 expression
    |
    Tyvyt (sintilimab) • Aidixi (disitamab vedotin)
    A Study of RC48-ADC Combined With JS001 For Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma (NCT05917158)
    Phase 2
    Jinling Hospital, China
    Recruiting
    Last update posted :
    06/23/2023
    Initiation :
    11/23/2022
    Primary completion :
    12/01/2027
    Completion :
    12/01/2028
    HER-2
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial) (NCT05904964)
    Phase 3
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Un...
    Recruiting
    Last update posted :
    06/22/2023
    Initiation :
    07/01/2023
    Primary completion :
    03/01/2028
    Completion :
    03/01/2030
    HER-2 • ER • PGR
    |
    HER-2 expression • PGR expression
    |
    Aidixi (disitamab vedotin)
    Combination of RC48 and Tislelizumab for Renal Preservation in High-risk UTUC Patients (NCT05912816)
    Phase 2
    RenJi Hospital
    Recruiting
    Last update posted :
    06/22/2023
    Initiation :
    06/10/2023
    Primary completion :
    12/10/2025
    Completion :
    12/10/2026
    HER-2
    |
    Tevimbra (tislelizumab-jsgr) • Aidixi (disitamab vedotin)