FIH Study of FGFR2 inhibitor RLY-4008 in ICC, Other Advanced Solid Tumour Patients
Research type
Research Study
Full title
A First-in-human Study of Highly Selective FGFR2 inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and other Advanced Solid Tumors
IRAS ID
1003629
Contact name
Kristy White
Contact email
Sponsor organisation
Relay Therapeutics, Inc.
Eudract number
2020-004535-24
Research summary
This is a study for patients with a type of cancer associated with changes in a protein called FGFR2. FGFR2 is thought to promote the growth of cancer cells in the types of cancer being researched in this study. These types of cancer may include intrahepatic cholangiocarcinoma (ICC) which is cancer of the bile duct inside the liver, or other types cancers in solid tumours.
FGFR2 gene changes are rare genetic changes that occur across different types of cancer. Other drugs referred to as pan-FGFR inhibitors have confirmed the role of FGFR2 alterations in both ICC and other solid tumour cancers. Clinical activity such as tumour shrinkage has been observed when treated with pan-FGFR inhibitors, suggesting FGFR inhibitors can treat different types of cancer. However, these pan-FGFR inhibitor drugs have shown toxicities and side effects.
There are currently no approved medicines that potently and selectively target FGFR2 alterations. RLY-4008, a potent and highly selective oral FGFR2 inhibitor, was developed to potentially provide greater tolerability, and medical benefit. The RLY-4008 data suggests a favourable risk-benefit profile for treatment of advanced cancer patients with limited treatment options.This is a 2-part study involving a dose-finding part (Part 1) to determine the dose that provides the most benefit with the least side effects, and an expansion part (Part 2) to confirm the chosen dose is safe. The study will be conducted at approximately 30 study sites in the United States, Europe, and Asia. Approximately 125 patients will participate in the study.
Participants will undergo a series of procedures such scans, collection of blood samples, ECGs, eye examinations, biopsies, pregnancy tests (if appropriate), physical examinations and questions to monitor their progress and health. The duration of the study for each patient will depend on the length of the treatment period.
This study is being funded by Relay Therapeutics, Inc.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0124
Date of REC Opinion
9 Jul 2021
REC opinion
Further Information Favourable Opinion