Advanced MTAP-null solid tumors
Conditions
Brief summary
Part 1 and 2: DLTs, treatment-emergent adverse events, serious adverse events, and changes in vital signs, ECGs, and clinical laboratory tests., Part 3: Objective response (defined as best overall response of confirmed CR or PR based on RECIST v1.1) derived utilizing investigator tumor assessments.
Detailed description
Part 1 and 2: PK parameters of AMG 193 alone and in combination with docetaxel., PK parameters of docetaxel (Parts 2a and 2b only) in combination with AMG 193 after multiple doses., Part 1 and 2 Objective response (defined as the best overall response of confirmed CR or PR based on RECIST v1.1), Disease Control (DC), Duration of Response (DoR), Duration of disease control (DoDC), Time to Response (TTR), Overall Survival (OS), Progression-Free Survival (PFS)
Interventions
DRUGAMG 193
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 and 2: DLTs, treatment-emergent adverse events, serious adverse events, and changes in vital signs, ECGs, and clinical laboratory tests., Part 3: Objective response (defined as best overall response of confirmed CR or PR based on RECIST v1.1) derived utilizing investigator tumor assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 and 2: PK parameters of AMG 193 alone and in combination with docetaxel., PK parameters of docetaxel (Parts 2a and 2b only) in combination with AMG 193 after multiple doses., Part 1 and 2 Objective response (defined as the best overall response of confirmed CR or PR based on RECIST v1.1), Disease Control (DC), Duration of Response (DoR), Duration of disease control (DoDC), Time to Response (TTR), Overall Survival (OS), Progression-Free Survival (PFS) | — |
Countries
Austria, Belgium, France, Germany
Outcome results
None listed