NCT07094113RecruitingPhase 1
AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
A Phase 1/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 434 (estimated)
- First submitted
- 23 Jul 2025
- Start date
- 31 Jul 2025
- Primary completion date
- 18 Apr 2028
- Lead sponsor
- Amgen
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT07094113
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 434
- From 31 Jul 2025 to the primary completion date, 18 Apr 2028
- 39 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment.
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment.
- 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.
Other illness
- History of other malignancy within the past 5 years.
- History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis).
- History of solid organ transplant.
- 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).
- 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.
Other
- Untreated symptomatic central nervous system or leptomeningeal metastases.
- Uncontrolled pleural effusion and/or ascites.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (39)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chris Obrien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Woodville South | Australia | Recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Sir Mortimer B Davis - Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Universitaetsklinikum - Essen Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Sarah Cannon Research Institute UK Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Centro Ricerche Cliniche Di Verona Societa responsabilita limitata Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Recruiting |
| Aichi Cancer Center Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Duke Cancer Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Sarah Cannon Research Institute - Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Siteman Cancer Center-Washington University Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.