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Disitamab Vedotin in ppts with HER2 Urothelial Carcinoma

  • Research type

    Research Study

  • Full title

    A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) in Subjects with HER2-Expressing Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma

  • IRAS ID

    1005288

  • Contact name

    Xuemei Li

  • Contact email

    xuli@seagen.com

  • Sponsor organisation

    Seagen Inc.

  • Eudract number

    0000-000000-00

  • Clinicaltrials.gov Identifier

    NCT04879329

  • Research summary

    This is a phase 2 study evaluating an investigational medication product (IMP) called disitamab vedotin, a drug antibody conjugate, for patients with advanced Urothelial Carcinoma (adv UC). Participants (ppts) recruited into this study will have experience disease progression after 1-2 lines of systemic therapy, including 1 line of platinum-containing therapy. Current therapies are very limited and have poor efficacy and survival timelines (<12months). Highlighting the clear unmet medical need for new therapies for adv UC.
    Many cancers, including about 1/2 of UC and bladder cancers express a protein called human epidermal growth factor receptor 2 (HER2). This IMP is made of two parts, an antibody part which detects HER2 and a medicine part, a chemotherapy. The IMP works to target the chemotherapy agent to the cancer cells.
    There are 5 ongoing or completed studies using the IMP in ppts with adv UC. In two of these studies the overall response rates (ORR) (the proportion of ppts in the study whose tumour was destroyed or significantly reduced) was 44 and 50%. Furthermore, safety studies have shown the IMP to be safe at the doses proposed in this study.
    There are two study groups A and B, those with more of HER2 expressed on their cancer cells and higher HER2 gene amplification (A) and those with less (B). In total 100 ppts will be recruited globally, 50 to each group.
    Study medication is given by intravenous (IV) (Vein) infusion once every two weeks. The ppts will be able to stay in the study until: disease progression, intolerable toxicity, withdrawal, death, or if the sponsor stops the study. Once the ppt stops taking the IMP they will be followed to assess disease progression.
    While participating in the study the ppt will have imaging assessments (e.g. CT scans) to visualise their tumour and quantify the treatment response. Participants will also have blood tests and asked to perform questionnaires to assess quality of life, as well as safety assessmt.

  • REC name

    North West - Greater Manchester Central Research Ethics Committee

  • REC reference

    22/NW/0144

  • Date of REC Opinion

    10 Jun 2022

  • REC opinion

    Further Information Favourable Opinion