Actively Recruiting
AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors
Led by Amgen · Updated on 2026-05-14
464
Participants Needed
9
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (or legal age if older than 18 in your country)
- Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor
- Archived tumor tissue available or willingness to undergo tumor biopsy before dosing
- Measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as defined by the study protocol
You will not qualify if you...
- Primary central nervous system (CNS) tumors
- Impaired cardiac function or significant cardiac disease
- Major surgery within 28 days before starting the trial
- Antitumor therapy within 21 days before first dose, except therapies with short half-life and appropriate washout
- Radiation therapy within 28 days before first dose, or palliative local/focal radiotherapy within 14 days
- Gastrointestinal conditions preventing oral medication intake, malabsorption syndrome, need for intravenous alimentation, or uncontrolled inflammatory gastrointestinal disease such as Crohn's disease or ulcerative colitis
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Next Oncology - Dallas
Irving, Texas, United States, 75039
Actively Recruiting
2
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia, 2298
Actively Recruiting
3
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
4
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
5
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
6
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
7
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
8
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
9
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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