AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
Recruiting · NCT07094113 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age ≥ 18 years (or \> legal age within the country if it is older than 18 years).
- Pathologically documented, locally-advanced or metastatic malignancy with any missense mutation in the KRAS gene or evidence of KRAS amplification using an analytically validated KRASWT amplification assay.
- Participants must have no standard of care treatment options or have actively refused such therapy.
- Able to swallow and retain per oral administered study treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator.
- Adequate organ function.
- Archival (formalin-fixed, paraffin-embedded \[FFPE\]) tumor tissue or block collected within 5 years before screening must be available. Participants without archived tumor tissue may undergo tumor biopsy before AMG 410 dosing (Day1).
Exclusion criteria
- Untreated symptomatic central nervous system or leptomeningeal metastases.
- Uncontrolled pleural effusion and/or ascites.
- History of other malignancy within the past 5 years.
- Active systemic infection or symptoms that indicate an acute and/or uncontrolled infection requiring IV antibiotics within 7days prior to the first dose of study treatment.
- History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis).
- Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment.
- History of solid organ transplant.
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment.
- Presence or history of any of the following viral infections: HIV, Hepatitis C, Hepatitis B, and active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Toxicities from prior anti-tumor therapy (including radiotherapy) not having improved to at least Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1.
- Therapeutic or palliative radiation therapy within 2 weeks of first dose of study treatment.
- Major surgery within 28 days of first dose of study treatment.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.
Where it is running
39 locations listed across 9 US states.
- City of Hope National Medical Center - Duarte, California, United States
- University of California Los Angeles - Los Angeles, 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
- Rigshospitalet - Copenhagen, Denmark
- Universitair Ziekenhuis Antwerpen - Edegem, Belgium
- Universitaetsklinikum Essen - Essen, Germany
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Sarah Cannon Research Institute UK - London, United Kingdom
- Centre Leon Berard - Lyon, France
- Fundacion Jimenez Diaz - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda - Milan, Italy
- Azienda Ospedaliero Universitaria Pisana - Pisa, Italy
- Seoul National University Hospital - Seoul, South Korea
- Asan Medical Center - Seoul, South Korea
- Royal Marsden Hospital - Sutton, United Kingdom
- Universitair Medisch Centrum Utrecht - Utrecht, Netherlands
- Centro Ricerche Cliniche Di Verona Societa responsabilita limitata - Verona, Italy
- Gustave Roussy - Villejuif, France
- Aichi Cancer Center - Nagoya, Aichi-ken, Japan
- Cross Cancer Institute - Edmonton, Alberta, Canada
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China
- Hospital Universitari Vall d Hebron - Barcelona, Catalonia, Spain
- National Cancer Center Hospital East - Kashiwa-shi, Chiba, Japan
- Chongqing University Cancer Hospital - Chongqing, Chongqing Municipality, China
- Chris OBrien Lifehouse - Camperdown, New South Wales, Australia
- Princess Margaret Cancer Centre - Toronto, Ontario, Canada
- Sir Mortimer B Davis - Jewish General Hospital - Montreal, Quebec, Canada
- Jinan Central Hospital - Jinan, Shandong, China
- The Queen Elizabeth Hospital - Woodville South, South Australia, Australia
- National Cancer Center Hospital - Chuo-ku, Tokyo, Japan
- Peter MacCallum Cancer Centre - Melbourne, Victoria, Australia