RecruitingPhase 1NCT07094113

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

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

Sponsor

Amgen

Enrollment

434 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

KRAS Altered Advanced or Metastatic Solid Tumors

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AMG 410 — alone or in combination with other medications — for people with advanced or metastatic solid tumors that have a specific genetic change called a KRAS mutation or KRAS amplification. KRAS is a gene that, when mutated, can drive cancer growth; targeting it is a newer and promising area of cancer treatment. **You may be eligible if...** - You are 18 years or older - You have advanced or metastatic solid tumor cancer with a confirmed KRAS mutation or KRAS gene amplification - You have no remaining standard treatment options, or you have chosen not to pursue them - Your cancer has at least one measurable area - You are in good physical condition (ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal fluid and is causing symptoms - You have uncontrolled fluid buildup around the lungs or abdomen - You have had another cancer in the past 5 years - You have active hepatitis B, hepatitis C, or HIV - You have had a blood clot, stroke, or heart attack - You have had major surgery or another cancer treatment in the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAMG 410

Administered as an oral tablet.

DRUGPembrolizumab

Administered as an intravenous (IV) infusion.

DRUGPanitumumab

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

View Full Details on ClinicalTrials.gov

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NCT07094113