A Phase 1b/2 Study:E7386+Pembrolizumab in Treated Cancer Subjects
Research type
Research Study
Full title
An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors
IRAS ID
303928
Contact name
Leo Ayerakwa
Contact email
Sponsor organisation
Eisai Limited
Eudract number
2021-001568-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
22/NE/0093, REC Booking reference n
Duration of Study in the UK
3 years, 8 months, days
Research summary
The purpose of this research is to better understand how the study drug works and why it may work well in some patients and not others by analysis of the provided genetic and biomarker samples.
Each Person’s blood and tumour tissue contain genes, proteins, lipids, and other components that serve as the “instruction book” for the cells that make up your body.
Everyone’s genetic make-up is a little different; information about these differences can help researchers understand how it is best administered, how it is processed by and removed from the body.
Biomarkers are substances or characteristics of a person’s body that could provide an indication of the presence and severity of a disease, or the response of your disease or condition to therapy. They may be found in blood, urine, tumour tissue.
The subject will take the study medication E7386 (Tablets taken by mouth twice daily) in combination with pembrolizumab.
E7386 is considered investigational, and is thought to work by affecting the way in which cancer cells grow and spread in the body.
Pembrolizumab, works by helping the subject immune system to fight their cancer and is approved in the USA and some other countries, is available by prescription to treat several different cancers, but may not be approved to treat their type of cancer.
The study is split into 2 parts described as Phase-1b and Phase-2. Phase 2 part of the study will be carried out in in United States of America, Europe and Asia/Pacific region, while Phase 1 part of the study will be performed in selected sites in Japan and United States.
The purpose of Phase 1b part of this study includes the following:
Determine the optimal dose of E7386 and pembrolizumab in combination that can be administered safely:
Recommend the dose of the combination of E7386 and pembrolizumab to be used in Phase 2:
Assess if there is a relationship between the amount of E7386 and pembrolizumab in the blood of adults who have cancer and how well their cancer responds to the treatment.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0093
Date of REC Opinion
11 Jul 2022
REC opinion
Further Information Favourable Opinion