A Phase 1b Study of AMG 193 in Advanced Non-small Cell Lung Cancer
Research type
Research Study
Full title
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)
IRAS ID
1009929
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2024-511253-21
Clinicaltrials.gov Identifier
Research summary
This study is being done to learn more about AMG 193 (a drug that inhibits the enzyme protein arginine methyltransferase 5, PRMT5 [important for cancer cell survival]) alone or in combination with other therapies in participants with advanced thoracic tumours [cancer that begins as a growth of cells in the thoracic cavity (a space inside chest) including the lungs] with methylthioadenosine phosphorylase (MTAP) deletion. MTAP deletion of the tumour is a requirement to be treated with AMG 193 because of how AMG 193 exerts its anticancer activity (inhibiting growth of cancer cells). MTAP deletion makes it easier for AMG 193 to target tumour cells to stop or slow down tumour growth. In participants with MTAP deleted tumours, AMG 193 may stop the growth and spread of these tumours. This study will see if AMG 193 alone or in combination with other therapies is safe to take and whether it causes any side effects and what doses of AMG 193 are safe for participants to take. This study will also look at preliminary effectiveness of AMG 193 and, how the body interacts with the study drug.
REC name
Wales REC 1
REC reference
24/WA/0232
Date of REC Opinion
21 Aug 2024
REC opinion
Further Information Unfavourable Opinion