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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2026-07-30)

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

๐ŸŸข Recruiting Phase 1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Amgen

๐Ÿฉบ Protocol 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.

Primary Research Facility: City of Hope National Medical Center (Duarte, California)

๐Ÿ“‹ Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

๐Ÿ“ Primary Site Map

Site: City of Hope National Medical Center โ€” Duarte, California

๐Ÿ“ All Participating Trial Locations (39 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. City of Hope National Medical Center โ€” Duarte, California
2. University of California Los Angeles โ€” Los Angeles, California
3. Emory University โ€” Atlanta, Georgia
4. Massachusetts General Hospital โ€” Boston, Massachusetts
5. Siteman Cancer Center - Washington University โ€” St Louis, Missouri
6. Duke Cancer Center โ€” Durham, North Carolina
7. Thomas Jefferson University โ€” Philadelphia, Pennsylvania
8. Sarah Cannon Research Institute Oncology Partners โ€” Nashville, Tennessee
9. Next Oncology โ€” San Antonio, Texas
10. Next Virginia โ€” Fairfax, Virginia
11. Chris OBrien Lifehouse โ€” Camperdown, New South Wales
12. The Queen Elizabeth Hospital โ€” Woodville South, South Australia
13. Peter MacCallum Cancer Centre โ€” Melbourne, Victoria
14. Universitair Ziekenhuis Antwerpen โ€” United States
15. Universitair Ziekenhuis Gent โ€” United States
16. Cross Cancer Institute โ€” Edmonton, Alberta
17. Princess Margaret Cancer Centre โ€” Toronto, Ontario
18. Sir Mortimer B Davis - Jewish General Hospital โ€” Montreal, Quebec
19. Beijing Cancer Hospital โ€” Beijing, Beijing Municipality
20. Chongqing University Cancer Hospital โ€” Chongqing, Chongqing Municipality
21. Jinan Central Hospital โ€” Jinan, Shandong
22. Rigshospitalet โ€” United States
23. Centre Leon Berard โ€” United States
24. Gustave Roussy โ€” United States
25. Universitaetsklinikum Essen โ€” United States

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๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

๐Ÿ’ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT07094113 โ€ข Last Synced: 2026-07-30
View on ClinicalTrials.gov โ†—
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