A Phase 1 Study of AMG 305 in Participants with Advanced Solid Tumours
Research type
Research Study
Full title
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
IRAS ID
1007853
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2022-502867-39
Clinicaltrials.gov Identifier
Research summary
This is a phase 1 study which means that AMG 305 has not been administrated to humans before. This study is being done to learn more about AMG 305 in people with selected advanced or metastatic (cancer which spreads throughout the body) solid tumours. Advanced solid tumors in this study include colorectal cancer (CRC), non-small cell lung cancer (NSCLC), mesothelioma (cancer of outer tissue which covers the lungs), pancreatic ductal adenocarcinoma (PDAC), gastric cancer (GC), head and neck squamous cell carcinoma (HNSCC), epithelial ovarian cancer (EOC) (cancer of female reproductive organ), cervical carcinoma (cancer of female reproductive organ), uterine endometrial carcinoma (cancer of lining of uterus [female reproductive organ]), and triple negative breast cancer.
These cancer types may have an excess amount of mesothelin (MSLN) and cadherin-3 (CDH3) (proteins that possibly cause cells to grow more quickly and multiply abnormally).
The purpose of this study is to obtain initial information on the safety and tolerability (good or bad effects) of AMG 305. Researchers want to obtain information on the side effects of AMG 305 and how participants with advanced solid tumours feel while taking AMG 305.
The study will also look at what doses of AMG 305 are safe for people to take and whether antitumour effects can be seen. The study also aims to learn more about the pharmacokinetics (how AMG 305 distributes in the body) and how it acts in the body. AMG 305 targets MSLN and CDH3.
Participants will receive AMG 305 as an intravenous (IV – into a vein) infusion every week, every 2 weeks or every 3 weeks, or as a subcutaneous (under the skin) injection every week, depending on which group participants are enrolled in.REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0955
Date of REC Opinion
29 Jan 2024
REC opinion
Further Information Favourable Opinion