A Study of AMG 193 in gastrointestinal, biliary and pancreatic cancers
Research type
Research Study
Full title
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion - Master Protocol
IRAS ID
1010213
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2024-511195-33
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]) in combination with other therapies in participants with advanced gastrointestinal (cancer along the digestive tract), biliary tract (cancer along the lining of biliary tract), or pancreatic cancers (cancer in cells of pancreas) 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 anti-tumour activity (inhibiting the growth of cancer cells).
MTAP-deletion makes tumours susceptible to treatment with AMG 193. In participants with MTAP-deleted tumours, AMG 193 may stop the growth and spread of these tumours. This study will see if AMG 193 in combination with other therapies is safe to take and whether it causes any side effects. This study will also look at 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
South Central - Oxford B Research Ethics Committee
REC reference
24/SC/0290
Date of REC Opinion
18 Oct 2024
REC opinion
Further Information Favourable Opinion