MCLA-158-CL01
Research type
Research Study
Full title
Phase 1 dose escalation and cohort expansion study evaluating single-agent MCLA-158 in metastatic colorectal cancer and other advanced solid tumors
IRAS ID
277234
Contact name
Jim Ford
Contact email
Sponsor organisation
Merus N.V.
Eudract number
2017-004745-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This a clinical study by Dutch pharmaceutical company Merus N.V. (“the sponsor”) evaluating a new product called MCLA-158.
MCLA-158 is an experimental product which has never been administered to patients prior to this study, though it has been studied in the laboratory and has been considered as safe for use in humans. However, we cannot guarantee this given that MCLA-158 has never been administered to humans. MCLA-158 is an antibody produced under controlled conditions in a laboratory. It targets proteins present on the surface of cells called EGFR and LGR5, which are present in large numbers in cancer cells. Results in the laboratory showed that when it links to these proteins, MCLA-158 interferes with messages inside the cell, preventing the cancer cells from multiplying. It is designed to also help the immune system (the body's cells and organs that fight illness and disease) to kill cancer cells by stimulating human antibodies which are proteins produced in the blood to fight diseases.
It has been demonstrated during laboratory tests and in animals implanted with human tumor cells, that MCLA-158 is capable of stopping the growth of human tumors.
This clinical study will evaluate the safety of MCLA-158 in patients with previously treated metastatic colorectal cancer and other malignancies including lung, liver, pancreas and head and neck cancers.
The main objective of this clinical study is to determine the recommended (safest) dose of MCLA-158. This will occur during the “escalation phase” with the first 20 to 40 patients enrolled. This dose will be confirmed during the “expansion phase” with additional patients.
The other objectives of the clinical study are to evaluate the potential activity against tumors and to assess the concentrations of the study drug (MCLA-158) in the blood (pharmacokinetics). The possible relationship between the presence of biomarkers (a measurable indicator of the severity or presence of some disease state) reflecting the status of your disease (which are obtained from tumor or blood samples) and antitumor activity of MCLA-158 will also be studied.REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/0495
Date of REC Opinion
27 May 2020
REC opinion
Further Information Favourable Opinion