AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors

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.

NCT Number	NCT07094113
Lead Sponsor	Amgen
Conditions	KRAS Altered Advanced or Metastatic Solid Tumors
Enrollment	434 participants
Start Date	2025-07-31
Primary Completion	2028-04-18 (estimated)
Study Completion	2031-04-20 (estimated)
Updated on ClinicalTrials.gov	2026-07-30