🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT07094113
Recruiting Phase 1

AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors

NCT07094113 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 1
Started
2025-07-31
Last updated
2026-07-30

Condition(s) studied

KRAS Altered Advanced or Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

AMG 410PembrolizumabPanitumumab

AMG 410: Administered as an oral tablet.

Pembrolizumab: Administered as an intravenous (IV) infusion.

Panitumumab: Administered as an IV infusion.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years (or \> legal age within the country if it is older than 18 years). 2. 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. 3. Participants must have no standard of care treatment options or have actively refused such therapy. 4. Able to swallow and retain per oral administered study treatment. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator. 7. Adequate organ function. 8. 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: 1. Untreated symptomatic central nervous system or leptomeningeal metastases. 2. Uncontrolled pleural effusion and/or ascites. 3. History of other malignancy within the past 5 years. 4. 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. 5. History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis). 6. Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment. 7. History of solid organ transplant. 8. Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment. 9. 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). 10. 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. 11. Therapeutic or palliative radiation therapy within 2 weeks of first dose of study treatment. 12. Major surgery within 28 days of first dose of study treatment. 13. 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.

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California Recruiting
University of California Los Angeles Los Angeles California Recruiting
Emory University Atlanta Georgia Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Siteman Cancer Center - Washington University St Louis Missouri Recruiting
Duke Cancer Center Durham North Carolina Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
Sarah Cannon Research Institute Oncology Partners Nashville Tennessee Recruiting
Next Oncology San Antonio Texas Recruiting
Next Virginia Fairfax Virginia Recruiting
Chris OBrien Lifehouse Camperdown New South Wales Recruiting
The Queen Elizabeth Hospital Woodville South South Australia Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
Universitair Ziekenhuis Antwerpen Edegem Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
Cross Cancer Institute Edmonton Alberta Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
Sir Mortimer B Davis - Jewish General Hospital Montreal Quebec Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Chongqing University Cancer Hospital Chongqing Chongqing Municipality Recruiting
Jinan Central Hospital Jinan Shandong Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
Centre Leon Berard Lyon France Recruiting
Gustave Roussy Villejuif France Recruiting
Universitaetsklinikum Essen Essen Germany Recruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milan Italy Recruiting
Azienda Ospedaliero Universitaria Pisana Pisa Italy Recruiting
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata Verona Italy Recruiting
Aichi Cancer Center Nagoya Aichi-ken Recruiting
National Cancer Center Hospital East Kashiwa-shi Chiba Recruiting
National Cancer Center Hospital Chuo-ku Tokyo Recruiting
Universitair Medisch Centrum Utrecht Utrecht Netherlands Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Hospital Universitari Vall d Hebron Barcelona Catalonia Recruiting
Fundacion Jimenez Diaz Madrid Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Sarah Cannon Research Institute UK London United Kingdom Recruiting
Royal Marsden Hospital Sutton United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07094113 on ClinicalTrials.gov ↗ ← All trials in the UK