disitamab vedotin   Click here for help

GtoPdb Ligand ID: 13716

Synonyms: Aidixi® | RC-48 | RC48-ADC
Approved drug
disitamab vedotin is an approved drug
Compound class: Antibody
Comment: Disitamab vedotin (RC48) is an anti-epidermal growth factor receptor 2 (ERBB2; HER2) antibody-drug conjugate (ADC) [4]. Its cytotoxic payload is the potent antimitotic agent monomethyl auristatin E (MMAE). Antibody binding blocks ERBB2 signalling and intracellular release of MMAE inhibits microtubule formation and induces apoptosis. The antibody may also mediate antibody-dependent cell-mediated cytotoxicity (ADCC).
No information available.
Summary of Clinical Use Click here for help
Disitamab vedotin as monotherapy or combination therapy has been evaluated for safety and efficacy in a range of HER2 positive solid tumour types, including breast cancer, endometrial cancer, urothelial cancer, gastric cancer, biliary tract cancer and non-small cell lung cancer. First worldwide approval was granted in China in June 2021 [1], indicated for previously treated HER2-overexpressing locally advanced or metastatic gastric cancer. In January 2022 the China approval was expanded to include treament of platinum-refractory metastatic urothelial cancer [3].
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT03500380 A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases Phase 2/Phase 3 Interventional RemeGen Co., Ltd.
NCT04400695 A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 Phase 3 Interventional RemeGen Co., Ltd.
NCT04714190 A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression Phase 3 Interventional RemeGen Co., Ltd.
NCT05302284 A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma Phase 3 Interventional RemeGen Co., Ltd.
NCT05723991 Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma Phase 4 Interventional Tongji Hospital
NCT05904964 Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial) Phase 3 Interventional Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NCT03809013 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 Phase 2 Interventional RemeGen Co., Ltd. 3