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

Recruiting now · Phase 1

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

In brief

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.

Key facts

Study ID

NCT07403721

Run by

Amgen

People needed

464

Starts

2026-04-08

Expected to finish

2028-07-28

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
• Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing.
• Tumor tissue (formalin-fixed, paraffin-embedded sample) archival block must be available. Participants without archived tumor tissue may enroll by undergoing tumor biopsy before dosing.
• Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
• Eastern Cooperative Oncology Group performance (ECOG) 0-1.
• Adequate organ function as defined in the protocol.

You may not qualify if…

• Participants with primary central nervous system (CNS) tumors.
• Impaired cardiac function or clinically significant cardiac disease.
• Major surgery within 28 days of trial day 1.
• Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 21 days of first dose of trial treatment, unless anti-tumor therapy is a therapy with 5 times the half-life being shorter than 21 days (in this case, enrollment may be allowed with washout from prior therapy of < 21 days.
• Radiation therapy within 28 days of the first dose of trial treatment (or local or focal radiotherapy with palliative intent within 14 days of the first dose).
• Gastrointestinal tract disease causing the inability to take per os (PO) medication, malabsorption syndrome, requirement for intravenous (IV) alimentation, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).

Where it is running

• City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States (enrolling)
• Midwestern Regional Medical Center dba City of Hope Chicago — Zion, Illinois, United States (enrolling)
• Community Health Network MD Anderson Cancer Center - North — Indianapolis, Indiana, United States (enrolling)
• New England Cancer Specialists — Westbrook, Maine, United States (enrolling)
• Tennessee Oncology PLLC — Nashville, Tennessee, United States (enrolling)
• Next Oncology - Dallas — Irving, Texas, United States (enrolling)
• Calvary Mater Newcastle Hospital — Waratah, New South Wales, Australia (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• Universite Catholique de Louvain Cliniques Universitaires Saint Luc — Brussels, Belgium (enrolling)
• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Hopital Saint Antoine — Paris, France (enrolling)
• Gustave Roussy — Villejuif, France (enrolling)
• Aichi Cancer Center — Nagoya, Aichi-ken, Japan (enrolling)
• National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan (enrolling)
• National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (enrolling)
• The Cancer Institute Hospital of Japanese Foundation for Cancer Research — Koto-ku, Tokyo, Japan (enrolling)
• Asan Medical Center — Seoul, South Korea (enrolling)
• Hospital Universitari Vall d Hebron — Barcelona, Catalonia, Spain (enrolling)
• Hospital Clinic i Provincial de Barcelona — Barcelona, Catalonia, Spain (enrolling)
• Clinica Universidad de Navarra — Madrid, Spain (enrolling)
• Taipei Veterans General Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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