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AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
Sponsor: Amgen
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.
Official title: A Phase 1/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
434
Start Date
2025-07-31
Completion Date
2031-04-20
Last Updated
2026-02-12
Healthy Volunteers
No
Interventions
AMG 410
Administered as an oral tablet.
Pembrolizumab
Administered as an intravenous (IV) infusion.
Panitumumab
Administered as an IV infusion.
Locations (27)
City of Hope National Medical Center
Duarte, California, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Siteman Cancer Center - Washington University
St Louis, Missouri, United States
Duke Cancer Center
Durham, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States
Next Oncology
San Antonio, Texas, United States
Next Virginia
Fairfax, Virginia, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Peter MacCallum Cancer Centre
Parkville, Victoria, Australia
Universitair Ziekenhuis Gent
Ghent, Belgium
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, Canada
Rigshospitalet
Copenhagen, Denmark
Centre Leon Berard
Lyon, France
Gustave Roussy
Villejuif, France
Universitaetsklinikum Essen
Essen, Germany
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, Italy
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Fundacion Jimenez Diaz
Madrid, Spain
Royal Marsden Hospital
Sutton, United Kingdom