Phase 1 Study of AMG 794 in CLDN6-positive NSCLC, Epithelial Ovarian Cancer, and Other Solid Tumours
Research type
Research Study
Full title
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 794 in Subjects With Claudin 6-positive Advanced/Metastatic Non-squamous Non-small Cell Lung Cancer or Epithelial Ovarian Cancer.
IRAS ID
1006155
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen
Eudract number
2022-002277-28
Clinicaltrials.gov Identifier
Research summary
This study is being done to learn more about AMG 794 in people with advanced Non-Small Cell Lung Cancer or Epithelial Ovarian Cancer. It will evaluate the safety and tolerability of AMG 794 and whether it causes any side effects. The study will also look at what doses of AMG 794 are safe for people to take and whether antitumor effects can be seen, which is when it stops abnormal cell growth.
AMG 794 is a molecule which targets Claudin 6 (CLDN6). CLDN6 is a protein involved in regulation of contact between cells. It acts as a physical barrier, which helps regulate transfer of substances as well as establish and maintain the shape, structure and function in epithelial and endothelial cells. High levels of CLDN6 are seen in some types of lung cancer (NSCLC) or EOC. CLDN6 plays a significant role in cancer formation and progression.
This is a phase 1 study which means that AMG 794 has not been administered to humans before. It has previously been tested in the laboratory and on animals.
The study will consist of two parts: a dose exploration (finding the best dose tolerated of the new treatment) and a dose expansion part (checking tolerability in more patients and how well the best dose of AMG 794 works to stop cancer growing).REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0208
Date of REC Opinion
30 Nov 2022
REC opinion
Further Information Favourable Opinion