AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
Start Date
7/31/2025
Completion Date
4/20/2031
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.
Detailed Description
This is a multicenter, multinational, open-label Phase 1/1b study designed to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of AMG 410 in adult participants with advanced or metastatic solid tumors characterized by KRAS alterations. The study will begin with a dose-escalation phase, during which AMG 410 will be administered orally, either as monotherapy or in combination with other agents. Dose escalation will follow a model-based approach to identify the MTD or RP2D. Following dose escalation, additional expansion cohorts may be enrolled at selected dose levels to further characterize the safety profile, PK/PD relationships, and preliminary efficacy in specific tumor types or molecular subgroups. Participants will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria. The maximum duration of AMG 410 administration in this study is 3 years.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AMG 410
Pembrolizumab
Panitumumab
Conditions
Locations
City of Hope National Medical Center
Duarte, California 91010
United States
University of California Los Angeles
Los Angeles, California 90095
United States
Emory University
Atlanta, Georgia 30322
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Siteman Cancer Center - Washington University
St Louis, Missouri 63110
United States
Duke Cancer Center
Durham, North Carolina 27710
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee 37203
United States
Next Oncology
San Antonio, Texas 78229
United States
Next Virginia
Fairfax, Virginia 22031
United States
Chris OBrien Lifehouse
Camperdown, New South Wales 2050
Australia
The Queen Elizabeth Hospital
Woodville South, South Australia 5011
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Belgium
Universitair Ziekenhuis Gent
Ghent, 9000
Belgium
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
Princess Margaret Cancer Centre
Toronto, Ontario M5G 1Z5
Canada
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec H3T 1E2
Canada
Beijing Cancer Hospital
Beijing, Beijing Municipality 100142
China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality 400044
China
Jinan Central Hospital
Jinan, Shandong 250013
China
Rigshospitalet
Copenhagen, 2100
Denmark
Centre Leon Berard
Lyon, 69008
France
Gustave Roussy
Villejuif, 94805
France
Universitaetsklinikum Essen
Essen, 45147
Germany
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Italy
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, 37134
Italy
Aichi Cancer Center
Nagoya, Aichi-ken 464-8681
Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba 277-8577
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Japan
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Netherlands
Seoul National University Hospital
Seoul, 03080
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Hospital Universitari Vall d Hebron
Barcelona, Catalonia 08023
Spain
Fundacion Jimenez Diaz
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Sarah Cannon Research Institute UK
London, W1G 6AD
United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT
United Kingdom