61186372NSC1003
Research type
Research Study
Full title
An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Amivantamab, a Human Bispecific EGFR and cMet Antibody for the Treatment of Advanced Solid Malignancies
IRAS ID
287766
Contact name
Matthew Krebs
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-003225-36
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
The investigational drug used in this study is called amivantamab and is being developed for the treatment of non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). Amivantamab, an antibody to two receptors; EGFR and cMet, shown in lung and other solid tumour cancers. These are known to increase survival and proliferation of cells, including cancer cells. By blocking this action, it is more difficult for cancer cells to proliferate and survive, as shown in animals and early data from an ongoing patient study whereby Amivantamab is given to patients intravenously (through the vein). In this study, patients with advanced NSCLC or other solid tumour cancer will be placed in a cohort (or group) where they will receive amivantamab subcutaneously (under the skin). Patients will be given amivantamab together with Recombinant Human Hyaluronidase (rHuPH20) or amivantamab alone. rHuPH20 is being used to increase the amount of space under the skin to absorb injected drugs and fluids. The purposes of this study are; 1) to see if subcutaneous (SC) amivantamab is safe and well tolerated, with and without rHuPH20 2) to find out how long SC amivantamab remains in and acts on the body 3) to find out how the body responds to amivantamab after a SC infusion and how useful amivantamab is in treating malignant solid tumours and 3) to find out which SC dose of amivantamab to use in the future. About 80 patients will take part in this study worldwide.
REC name
London - City & East Research Ethics Committee
REC reference
20/LO/1081
Date of REC Opinion
12 Oct 2020
REC opinion
Favourable Opinion