drugset
drugset / Trial / NCT07094113

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

NCT07094113 ↗

Phase 1 Recruiting 434 enrolled Amgen
Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2025-07-31
Primary completion
2028-04-18
Completion
2031-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject AMG 410 Unknown — Oral
Subject Panitumumab Monoclonal antibody — Intravenous
Subject Pembrolizumab Monoclonal antibody — Intravenous

Indications

No indication recorded.