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RECRUITING
NCT07094113
PHASE1

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

Sponsor: Amgen

View on ClinicalTrials.gov

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

2026-07-10

Healthy Volunteers

No

Interventions

DRUG

AMG 410

Administered as an oral tablet.

DRUG

Pembrolizumab

Administered as an intravenous (IV) infusion.

DRUG

Panitumumab

Administered as an IV infusion.

Locations (37)

City of Hope National Medical Center

Duarte, California, United States

University of California Los Angeles

Los Angeles, 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

Melbourne, Victoria, Australia

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sir Mortimer B Davis - Jewish General Hospital

Montreal, Quebec, Canada

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Jinan Central Hospital

Jinan, Shandong, China

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

Azienda Ospedaliero Universitaria Pisana

Pisa, 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

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Sarah Cannon Research Institute UK

London, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom