Sotorasib in patients with Advanced Solid Tumours with KRAS Mutation
Research type
Research Study
Full title
A Phase 1b/2, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN Sotorasib) in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation
IRAS ID
304235
Contact name
Elisa Fontana
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2020-004721-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
This study is being undertaken to review the results of treatment with Sotorasib, an oral drug, in patients with varying solid tumour cancers that are also known to have the KRAS p.G12C mutation. Lung and colorectal solid tumour cancers are in the top 3 most common cancers globally and with present treatment options 5 year survival rates have a huge variance. A small group of patients with this cancer diagnosis test positive for the KRAS p.G12C mutation, a mutation in the tumour that is known to be the most frequently mutated in most cancers. This study is to confirm if Sotorasib is safe and tolerated to a reasonable level and establish if this drug is an effective treatment for those suffering with cancer that presents this mutation.
The mutation occurs in approx. 13% of lung carcinoma and less than 5% of other solid tumour cancers and is a difficult mutation to target, up until now known as the “untreatable mutation”. Due to this there is no effective targeted treatment regime for these patients, who currently will undertake combination treatment of chemotherapy, immunotherapy and anti-angiogenic therapies.
Potential participants will have a confirmed pathological diagnosis of KRAS p.G12C mutated cancer and have a life expectancy of at least 3 months and be eligible per the inclusion/exclusion criteria for the respective sub-protocol that the study investigator deems appropriate.
This study is a global study taking part in over 80 locations and overall approx. 1000 participants are expected to be enrolled across all sub-protocols, they will participate for approx. 3 years with the study end estimated to be 2025.
Participants will undergo several, possibly long, visits to the research site and have blood samples taken, be asked questions on their health, have body measurement recorded and receive study treatment to take every day at home.
REC name
HSC REC A
REC reference
22/NI/0009
Date of REC Opinion
23 Mar 2022
REC opinion
Further Information Favourable Opinion