A Phase 1/1b Study of AMG 410 Alone and with Other Agents in KRAS-Altered Advanced Solid Tumours
Research type
Research Study
Full title
A Phase 1/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 410 Alone and in Combination with other agents in Participants with KRAS Altered Advanced or Metastatic Solid Tumors
IRAS ID
1012278
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2025-521707-48
Clinicaltrials.gov Identifier
Research summary
This study is investigating a new experimental cancer treatment, called AMG 410, which targets specific changes in a gene known as KRAS. Changes (or mutations) in the KRAS gene are commonly found in several cancers, including lung, bowel, and pancreatic cancer. These changes can cause cancer cells to grow and spread.
The aim of the study is to test whether AMG 410 is safe, how well it is tolerated, and how the body absorbs and processes the drug. The study will also look at how AMG 410 may affect cancer growth, either when used on its own or when combined with other cancer medicines called pembrolizumab (an immunotherapy) or panitumumab (a targeted therapy).
This is an early-phase trial (Phase 1/1b), and participants must have advanced cancer that has either spread to other parts of the body or cannot be removed by surgery. All participants must have a KRAS gene alteration confirmed through tumour testing. People taking part may have already tried standard cancer treatments or may not be suitable for those treatments.
The study has several parts. In the early part, different doses of AMG 410 will be tested to find the highest dose that can be given safely. Later, larger groups of participants will receive the selected dose(s) to better understand how safe the treatment is and whether there are any early signs that it may help stop the cancer from growing.
There is also a small sub-study to investigate whether eating different types of meals (for example, high-fat or low-fat meals) affects how AMG 410 is absorbed by the body. This part of the study is only available to participants in the United States.
Tumour samples and blood tests will help researchers understand how AMG 410 works in the body and in cancer cells.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
25/YH/0185
Date of REC Opinion
17 Oct 2025
REC opinion
Further Information Favourable Opinion