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ACTIVE NOT RECRUITING Phase 1

A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

NCT06131398 · View on ClinicalTrials.gov ↗

Study Summary

The primary objectives of this study are to: * Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors * Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors.

Conditions Studied

Interventions

  • DRUG Pembrolizumab
  • DRUG AMG 355

Study Locations (20)

Other

  • Institut Bergonie — Bordeaux
  • Gustave Roussy — Villejuif
  • Radboud Universitair Medisch Centrum — Nijmegen
  • Erasmus Medisch Centrum — Rotterdam
  • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy — Warsaw
  • Seoul National University Hospital — Seoul
  • Asan Medical Center — Seoul

Catalonia

  • Hospital Universitari Vall d Hebron — Barcelona
  • Hospital Clinic i Provincial de Barcelona — Barcelona

California

  • City of Hope National Medical Center — Duarte

Kansas

  • Alliance for Multispecialty Research - Kansas City — Merriam

Massachusetts

  • Dana-Farber Cancer Institute — Boston

Missouri

  • Washington University — St Louis

North Carolina

  • Wake Forest University Health Sciences — Winston-Salem

Texas

  • South Texas Accelerated Research Therapeutics — San Antonio

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2024-03-07
Est. Completion 2026-08-03
Phase Phase 1

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06131398

The ClinicalTrials.gov registry entry for NCT06131398 describes a study currently listed as active not 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 77 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 Advanced Solid Tumors appearing as the primary indexed condition, and to 2 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: NCT06131398 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Catalonia, California. 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 NCT06131398 about?

NCT06131398 is a clinical study titled "A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors". The primary objectives of this study are to: * Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors * Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in co...

What is the current status of trial NCT06131398?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2024-03-07. Estimated completion is 2026-08-03.

What conditions does trial NCT06131398 study?

This clinical trial studies the following conditions: Advanced 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 NCT06131398?

The interventions under investigation include: Pembrolizumab (DRUG), AMG 355 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06131398?

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 NCT06131398 being conducted?

This trial has 20 study locations across California, Kansas, 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