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RECRUITING Phase 1

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

NCT07094113 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 434 participants
Start Date 2025-07-31
Est. Completion 2031-04-20
Phase Phase 1

Sponsor

Amgen

266 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07094113 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07094113?

The interventions under investigation include: Pembrolizumab (DRUG), Panitumumab (DRUG), AMG 410 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07094113?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial