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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
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

Full criteria on ClinicalTrials.gov

Sites (39)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chris Obrien Lifehouse
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CamperdownAustraliaRecruiting
Peter MacCallum Cancer Centre
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MelbourneAustraliaRecruiting
The Queen Elizabeth Hospital
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Woodville SouthAustraliaRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
Universitair Ziekenhuis Gent
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GhentBelgiumRecruiting
Cross Cancer Institute
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EdmontonCanadaRecruiting
Sir Mortimer B Davis - Jewish General Hospital
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MontrealCanadaRecruiting
Princess Margaret Cancer Centre
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TorontoCanadaRecruiting
Beijing Cancer Hospital
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BeijingChinaRecruiting
Chongqing University Cancer Hospital
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ChongqingChinaRecruiting
Jinan Central Hospital
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JinanChinaRecruiting
Universitaetsklinikum - Essen
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EssenGermanyRecruiting
Rigshospitalet
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CopenhagenDenmarkRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Fundación Jiménez Díaz
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MadridSpainRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Gustave Roussy
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VillejuifFranceRecruiting
Sarah Cannon Research Institute UK
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LondonUnited KingdomRecruiting
Royal Marsden Hospital
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SuttonUnited KingdomRecruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
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VeronaItalyRecruiting
National Cancer Center Hospital
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Chuo KuJapanRecruiting
National Cancer Center Hospital East
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Kashiwa-shiJapanRecruiting
Aichi Cancer Center
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NagoyaJapanRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
Emory University
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AtlantaUnited StatesRecruiting
Massachusetts General Hospital
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BostonUnited StatesRecruiting
City of Hope National Medical Center
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DuarteUnited StatesRecruiting
Duke Cancer Center
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DurhamUnited StatesRecruiting
NEXT Virginia
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FairfaxUnited StatesRecruiting
University of California, Los Angeles
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Los AngelesUnited StatesRecruiting
Sarah Cannon Research Institute - Oncology Partners
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NashvilleUnited StatesRecruiting
Thomas Jefferson University
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PhiladelphiaUnited StatesRecruiting
NEXT Oncology
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San AntonioUnited StatesRecruiting
Siteman Cancer Center-Washington University
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St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.