RecruitingPhase 1NCT07403721

AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors

A Phase 1/1b Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 436 as Monotherapy and in Combination With Other Therapies in Participants With Microsatellite Instability-high (MSI-H)/Mismatch Repair Deficient (dMMR) Solid Tumors

Sponsor

Amgen

Enrollment

464 participants

Start Date

Apr 8, 2026

Study Type

INTERVENTIONAL

Conditions

Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)

Summary

The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H/dMMR solid tumors.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AMG 436 for people with metastatic or locally advanced solid tumors with microsatellite instability-high (msi-h) or mismatched repair deficiency (dmmr). The study is currently recruiting participants at 20 locations. People eligible for this study include aged 18 Years to 99 Years.

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 436

AMG 436 will be administered.

Locations(20)

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Midwestern Regional Medical Center dba City of Hope Chicago

Zion, Illinois, United States

New England Cancer Specialists

Westbrook, Maine, United States

Tennessee Oncology PLLC

Nashville, Tennessee, United States

Next Oncology - Dallas

Irving, Texas, United States

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Hopital Saint Antoine

Paris, France

Gustave Roussy

Villejuif, France

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

Clinica Universidad de Navarra

Madrid, Spain

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07403721