Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2+ Gastric Cancer
Research type
Research Study
Full title
A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants with HER2 Overexpressing Gastric Cancer (DESTINY-Gastric03)
IRAS ID
1003430
Contact name
Niloufar Davoudi
Contact email
Eudract number
2019-004483-22
Clinicaltrials.gov Identifier
Research summary
Trastuzumab deruxtecan (T-DXd, DS-8201a) is a type of anti-cancer drug called an ‘antibody drug conjugate’ (ADC) that targets cancer cells. One part of this study drug is a protein called a monoclonal antibody that recognises and attaches to cells that have a specific protein called HER2 on their surface. Another part of this drug contains a chemotherapy-like molecule called DXd. When trastuzumab deruxtecan binds to a HER2 protein on a cancer cell, the DXd is released into the cancer cell damaging or killing it.
We are doing this study to learn more about how trastuzumab deruxtecan might provide benefits to patients with cancer. This research study is designed to see if the study drug given by itself or in combination with immunotherapy or chemotherapy will be safe and will work for the treatment of your type of cancer. Pembrolizumab is an immunotherapy drug that blocks the activity of a molecule called PD-1 which prevents T cells (a type of white blood cell) from recognizing and attacking cancer cells. By blocking PD-1, pembrolizumab increases your immune system’s ability to kill cancer cells. The standard or usual initial treatment for your disease consists of trastuzumab, 5-fluorouracil (5-FU) or capecitabine, and cisplatin or oxaliplatin.
In addition to investigating effects of trastuzumab deruxtecan combinations, we are also trying to better understand the studied disease and associated health problems. The study will aim to determine the appropriate doses of trastuzumab deruxtecan in combinations with capecitabine or 5-FU, oxaliplatin, and pembrolizumab that offer maximum benefit with least side effects. We are also trying to test the anti-cancer effect of these drugs in gastric, GEJ and esophageal cancer patients. About 387 people from approximately 14 countries will take part in this study and it is estimated about 290 people will receive study drug.REC name
London - Hampstead Research Ethics Committee
REC reference
21/LO/0032
Date of REC Opinion
9 Feb 2021
REC opinion
Further Information Favourable Opinion