A Study of Disitamab Vedotin Alone or with Other Anticancer Drugs in Solid Tumors
Research type
Research Study
Full title
A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination with Other Anticancer Therapies in Solid Tumors
IRAS ID
1009441
Contact name
Xuemei LI
Contact email
Sponsor organisation
Seagen Inc.
Eudract number
2023-507555-29
Research summary
This clinical trial is studying solid tumour cancers. Subjects in this study must have breast cancer or gastric cancer and their tumours must have tumours that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumours that express HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial uses a drug called tucatinib (brand name TUKYSA®), which has been approved to treat cancer in the United States and other countries. This study has 3 different groups. Subjects will be assigned to a group based on their type of cancer and how much HER2 their tumour makes. All subjects will get DV once during each cycle, which is 2 weeks in duration. Some subjects may also get a drug called tucatinib. Tucatinib is a pill that will be swallowed twice a day every day starting on Day 1 of each cycle. While subjects are getting the study drugs, clinic visits will happen once each cycle. After subjects finish getting the study drugs, study staff will contact them every 2 months as long as their cancer stays the same or gets better. After that, subjects will be contacted every 3 months during follow-up. Subjects will also continue imaging scans every 2 to 3 months.
Subjects may keep getting DV as long as their 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.REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0285
Date of REC Opinion
13 Jun 2024
REC opinion
Further Information Favourable Opinion