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NCT07094113 · ClinicalTrials.gov registry record · Phase 1
AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
A Phase 1 study of KRAS Altered Advanced or Metastatic Solid Tumors, sponsored by Amgen.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 434
- Enrollment target
- 20
- Study locations
NCT07094113 is a Phase 1 study of KRAS Altered Advanced or Metastatic Solid Tumors that is actively recruiting participants, run by Amgen. The registered enrollment target is 434 participants. The trial reports 20 study locations across 15 states.
The verdict
NCT07094113, a Phase 1 study of KRAS Altered Advanced or Metastatic Solid Tumors, is actively recruiting participants, sponsored by Amgen.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 434 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Panitumumab
- DRUG AMG 410
Study Locations (20)
Other
- Universitair Ziekenhuis Gent - Ghent
- Rigshospitalet - Copenhagen
- Centre Leon Berard - Lyon
- Gustave Roussy - Villejuif
- Universitaetsklinikum Essen - Essen
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda - Milan
California
- City of Hope National Medical Center - Duarte
Georgia
- Emory University - Atlanta
Massachusetts
- Massachusetts General Hospital - Boston
Missouri
- Siteman Cancer Center - Washington University - St Louis
North Carolina
- Duke Cancer Center - Durham
Pennsylvania
- Thomas Jefferson University - Philadelphia
Tennessee
- Sarah Cannon Research Institute Oncology Partners - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 434 participants |
| Start Date | 2025-07-31 |
| Est. Completion | 2031-04-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07094113
The ClinicalTrials.gov registry entry for NCT07094113 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 434 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with KRAS Altered Advanced or Metastatic Solid Tumors appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT07094113 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT07094113 about?
NCT07094113 is a clinical study titled "AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors". 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 alte...
What is the current status of trial NCT07094113?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 434 participants. The study started on 2025-07-31. Estimated completion is 2031-04-20.
What conditions does trial NCT07094113 study?
This clinical trial studies the following conditions: KRAS Altered Advanced or Metastatic Solid Tumors.
What interventions are being tested in trial NCT07094113?
The interventions under investigation include: Pembrolizumab (DRUG), Panitumumab (DRUG), AMG 410 (DRUG).
Who is sponsoring clinical trial NCT07094113?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07094113 being conducted?
This trial has 20 study locations across California, Georgia, Massachusetts, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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