A Phase I/II Study of AZD5863 in Adult Participants with Advanced or Metastatic Solid Tumors
Research type
Research Study
Full title
A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T cell-engaging Bispecific Antibody that Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants with Advanced or Metastatic Solid Tumors
IRAS ID
1008310
Contact name
Ghada Chaabani
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2023-000154-20
Research summary
When a patient has advanced or metastatic gastric (stomach), oesophageal (gullet) or pancreas cancer, this means that surgery will not be possible to remove the cancer. Instead, chemotherapy or chemotherapy plus immunotherapy is recommended, dependent on the cancer type. However, current treatments are not usually successful in shrinking or controlling cancer for long. As a result, researchers are looking for treatments which might be better than the current available treatments. The trial drug, AZD5863, is designed to help the immune system fight cancer. This is a first-in-human trial, which means that this will be the first time that anyone has received AZD5863. In this trial, the researchers want to learn more about how AZD5863 affects people with advanced or metastatic solid tumours.
This trial has 2 modules which each has 2 parts. In Part A of each module, the researchers will increase the dose of the trial drug for each group of participants until they find the best dose or doses for Part B of each module. In Part B of each module, the researchers will look at how well the best dose(s) work(s) for more participants. The best dose is determined based on the results of side effects and whether the drug has resulted in tumour shrinkage.
AstraZeneca is the sponsor of this trial, and patients will be recruited from UK, China, France, Japan, Netherlands, South Korea, Taiwan and USA. The first 2 modules of this trial will include up to 200 participants, depending on how many doses are studied. All participants in this trial will be 18 years of age or older and have advanced or metastatic gastric, oesophageal or pancreatic cancer. Participants’ tumours must express CLDN18.2.
In Module 1 the trial drug, AZD5863 will be administered through a needle into a vein (intravenous infusion, also called IV infusion). In Module 2, AZD5863 will be administered through a needle under the skin (subcutaneous injection).REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0841
Date of REC Opinion
17 Jan 2024
REC opinion
Further Information Favourable Opinion