AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
Study Details
The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AMG 410 when administered alone or in combination with other agents in participants with advanced or metastatic solid tumors harboring KRAS alterations.
This is a dose-escalation study in which participants will be assigned to multiple dose levels (DLs) of AMG 410, either as monotherapy or in combination with other agents, followed by expansion cohorts. The goal is to determine the Maximum Tolerated Dose (MTD)—the highest dose with acceptable safety and manageable side effects—or the Recommended Phase 2 Dose (RP2D) of AMG 410 in adult participants with KRAS-altered advanced or metastatic solid tumors.
Protocol Summary
Number of Participants with Dose Limiting Toxicities (DLTs)
Timeframe: Up to 28 days
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 3 years
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to approximately 3 years
Maximum Concentration (Cmax) of AMG 410
Timeframe: Up to 85 days
Time to Reach Cmax (Tmax) of AMG 410
Timeframe: Up to 85 days
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 410
Timeframe: Up to 85 days
Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timeframe: Up to approximately 3 years
Clinical Benefit per RECIST v1.1
Timeframe: Up to approximately 3 years
Duration of Response (DoR) per RECIST v1.1
Timeframe: Up to approximately 3 years
Time to Response (TTR) per RECIST v1.1
Timeframe: Up to approximately 3 years
Progression-free Survival (PFS) per RECIST v1.1
Timeframe: Up to approximately 3 years
Overall Survival (OS)
Timeframe: Up to approximately 3 years
Food Effect Substudy Cohort: Cmax of AMG 410 in the Fed and/or Fasted State
Timeframe: Up to 24 days
Food Effect Substudy Cohort: Tmax of AMG 410 in the Fed and/or Fasted State
Timeframe: Up to 24 days
Food Effect Substudy Cohort: AUC Over the Dosing Interval of AMG 410 in the Fed and/or Fasted State
Timeframe: Up to 24 days
Change From Baseline in Tumor Phosphorylated Extracellular Signal Regulated Kinase (pERK)
Timeframe: Baseline up to approximately 3 years