Actively Recruiting
AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
Led by Amgen · Updated on 2026-02-12
434
Participants Needed
27
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (or older if legal age in country is above 18)
- Diagnosed with locally-advanced or metastatic cancer with KRAS gene mutation or amplification
- No standard treatment options available or have declined such treatments
- Able to swallow and keep oral study medication
- ECOG Performance Status of 0 or 1
- Measurable disease by RECIST v1.1 criteria
- Adequate organ function
- Available tumor tissue collected within 5 years before screening or willing to undergo biopsy before treatment
You will not qualify if you...
- Untreated symptomatic central nervous system or leptomeningeal metastases
- Uncontrolled pleural effusion or ascites
- History of another cancer within the past 5 years
- Active systemic infection or needing IV antibiotics within 7 days before first dose
- History of arterial or venous blood clots (stroke, TIA, pulmonary embolism, DVT)
- Receipt of live or live-attenuated vaccines within 28 days before first dose
- History of solid organ transplant
- Anti-tumor therapy within 28 days before first dose
- Positive for HIV, Hepatitis B, Hepatitis C, or active COVID-19 infection
- Unresolved side effects from prior anti-cancer therapy above CTCAE grade 1
- Radiation therapy within 2 weeks before first dose
- Major surgery within 28 days before first dose
- Any other medical condition that could risk participant safety according to investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 27 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Siteman Cancer Center - Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
6
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
7
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
Next Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
9
Next Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
10
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
11
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Actively Recruiting
12
Peter MacCallum Cancer Centre
Parkville, Victoria, Australia, 3050
Actively Recruiting
13
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
14
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
15
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
16
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
17
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
18
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
19
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
20
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
21
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, Italy, 37134
Actively Recruiting
22
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
23
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
24
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
25
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
26
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
27
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
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
6
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