A Phase I/II Study of MCLA-128 targeting HER2 & HER3 in Solid Tumours
Research type
Research Study
Full title
A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors (eNRGy)
IRAS ID
294072
Contact name
Elisa Fontana
Contact email
Sponsor organisation
Fortrea- form. Labcorp Clinical Development Limited
Eudract number
2014-003277-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
years, 18 months, 0 days
Research summary
The main purpose of this study is to test the safety of the study drug MCLA-128 in patients with solid tumours (epithelial type) and see what effects it has on patients and their cancer. The study also aims to examine the way MCLA-128 is processed by the body (called pharmacokinetics, PK) and will look at the effects of MCLA-128 by measuring the presence of biomarkers, small substances in the body (pharmacodynamics, PD). This study consists of two parts and will include up to approximately 250 patients. Enrollment into Part 1 of the study has been completed with a total of 28 patients included. Patients will now be involved in Part 2 (expansion phase), where the safety of MCLA-128 is further characterized while exploring the anti-tumour activity of the drug. Up to approximately 220 patients may be included in Part 2. The study will include patients who have a tumour that has an NRG1 fusion, a mutation in the NRG1 gene can lead to activation of HER2/HER3. MCLA-128 is an experimental treatment and it has not yet been approved for sale by any regulatory authority anywhere in the world. MCLA-128 is a human bispecific IgG1 antibody that simultaneously targets HER2 and HER3. Which means; it is a type of a protein produced to mimic a certain category of antibodies called IgG1, which the immune system makes. Duration of each cycle is 4 weeks and patients will receive MCLA-128 every 2 weeks. Patients will receive one dose of 750 mg of MCLA-128, by intravenous infusion over 4 hours at day 1 of the first treatment cycle (Cycle 1) and subsequently, the same dose every two weeks therafter over 2 hours. Receiving next doses depends on evaluation of safety and tolerability of MCLA-128 and status of each patient's cancer.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0094
Date of REC Opinion
11 Jun 2021
REC opinion
Further Information Favourable Opinion