A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

  • Research type

    Research Study

  • Full title

    A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2

  • IRAS ID

    1009207

  • Contact name

    Xuemei LI

  • Contact email

    EU-Regulatory@seagen.com

  • Sponsor organisation

    Seagen Inc.

  • Clinicaltrials.gov Identifier

    NCT06003231

  • Research summary

    This clinical trial is studying advanced or metastatic solid tumours. Solid tumours start in a part of your body like your lungs or liver instead of your blood. Once they have grown very large in one spot or have spread to other places in the body, it is called advanced or metastatic cancer and can be very hard to treat. Subjects in this study must have head and neck squamous cell cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. Subjects must have tumours SGNDV- that have a marker called HER2. There are limited treatment options for patients with advanced or metastatic solid tumours that have HER2 on them.
    This clinical trial uses an experimental drug called disitamab vedotin. Disitamab vedotin is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. In this study, all subjects will get disitamab vedotin once every 2 weeks.
    While subjects are getting disitamab vedotin, clinic visits will happen once every 2 weeks. After subjects finish getting disitamab vedotin, study staff will contact the subject about every 3 months. Subjects will also keep having imaging scans about every 6 weeks for about the first year and a half, then every 3 months after that. Subjects may keep getting disitamab vedotin as long as the study is open, the cancer is stable or gets better, the side effects are not too bad, and the study doctor thinks it’s in the subject’s best interest to continue. The total time a subject could be in the clinical trial is about 3 years.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    24/WM/0072

  • Date of REC Opinion

    17 Jul 2024

  • REC opinion

    Further Information Favourable Opinion