A Phase 1 study evaluating AMG 337 in Asian patients with advanced solid tumors

Area of Science:

• Oncology
• Pharmacology
• Clinical Trials

Background:

• AMG 337 is a selective small-molecule MET inhibitor.
• MET pathway dysregulation is implicated in various advanced solid tumors.

Purpose of the Study:

• Evaluate the safety, tolerability, pharmacokinetics, and efficacy of AMG 337 in Asian patients with advanced solid tumors.
• Determine dose-limiting toxicities (DLTs) and common adverse events (AEs).

Main Methods:

• Open-label, modified 3+3+3 design study.
• Oral administration of AMG 337, with dose escalation from 150 mg to 300 mg once daily (QD).
• Treatment continued until disease progression, intolerability, or death.

Main Results:

• Eleven patients were enrolled; no DLTs were observed.
• Most frequent AEs included headache (73%) and nausea (45%).
• Pharmacokinetics showed dose-proportional exposure, minimal accumulation, and consistent half-life; one partial response and one stable disease were observed.

Conclusions:

• AMG 337 demonstrated acceptable safety and tolerability in this Asian patient cohort.
• Pharmacokinetic and efficacy findings were consistent with previously observed data in Western populations.
• The study was terminated early, but initial results support further investigation of AMG 337.