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 accepta

Trial Details

NCT ID
NCT07094113
Phase
PHASE1
Sponsor
Amgen
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • AMG 410
  • Pembrolizumab
  • Panitumumab
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Durham, North Carolina, United States|35.99403,-78.89862

Key Eligibility Criteria

  • Age ≥ 18 years (or \> legal age within the country if it is older than 18 years).
  • Pathologically documented, locally-advanced or metastatic malignancy with any missense mutation in the KRAS gene or evidence of KRAS amplification …
  • Participants must have no standard of care treatment options or have actively refused such therapy.
  • Able to swallow and retain per oral administered study treatment.

For full eligibility, visit ClinicalTrials.gov.

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