MP0274-CP101
Research type
Research Study
Full title
A phase 1, first-in-human, single-arm, multi-center, open-label, repeated dose, dose escalation study to assess safety, tolerability, and pharmacokinetics of MP0274 in patients with advanced HER2-positive solid tumors.
IRAS ID
222863
Contact name
Richard Baird
Contact email
Sponsor organisation
Molecular Partners AG
Eudract number
2016-004712-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 0 days
Research summary
Research Summary
This study is designed to collect information on the safety, tolerability, and anti tumour activity of an experimental drug called MP0274 (study drug). The study also aims to examine how the drug is changed by and removed from the body and look for indicators that the drug may be effective against cancer. Experimental means that MP0274 is not yet registered as a medicine and not yet available for prescription in the UK.MP0274 is a novel drug candidate and has the potential to improve the outcome of patients treated for HER2-dependent tumours. This is due to its mechanism of action, which is different from those of the established HER2-binding antibody drugs. HER2 (human epidermal growth factor receptor 2) is a molecule on tumour cells that promotes tumour cell growth. Laboratory experiments have shown that MP0274 can bind to HER2-positive tumour cells and trigger their death. The purpose of the study is to assess if the study drug can be safely administered to patients and may provide additional benefits for the treatment of HER2-positive tumours.
In this clinical study, MP0274 will be given to humans for the first time. This is an open-label and single-arm study. Open label means that both the patient and the study doctor know which treatment the patient will be receiving in this study (ie, MP0274). Single arm means that every patient will receive the same type of study treatment.
Summary of Results
Study enrollment was prematurely discontinued during part A of the study (dose escalation) due to recent advances in the treatment of HER2-positive tumors. However, the study drug (MP0274) showed a well-tolerated safety profile across doses administered. The reactions to infusion of the study drug were manageable with premedication and treatment. Evaluation of the highest dose level was not completed as only one patient was included at this dose, and the recommended dose was not established. There were no obvious clinically meaningful trends across dose levels for any safety measure. Once MP0274 enters the body it is distributed and eliminated by the body consistent with other drugs that bind to the target receptors.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0222
Date of REC Opinion
31 Jul 2017
REC opinion
Further Information Favourable Opinion