AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
Clinicaltrials.gov ID
NCT05094336
Status
Recruiting
Study Type
Interventional, Phase 1/2
Sponsor
Amgen
Start Date
1 février 2022
Anticipated End Date
27 février 2026
Study Contact
About the Study
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.
The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors.
Conditions
Advanced MTAP-null Solid Tumors
Inclusion/Exclusion Criteria?
Primary, Secondary, Other Outcome Measures??
Locations in Canada
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9, Canada
About the Study
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.
The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors.
Conditions
Advanced MTAP-null Solid Tumors
Interventions
DRUG:
AMG 193
Docetaxel
Comparator AMG 193 Test Tablet
Locations in Canada
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9, Canada