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ACTIVE NOT RECRUITING
NCT06131398
PHASE1

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

Sponsor: Amgen

View on ClinicalTrials.gov

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.

Official title: A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

77

Start Date

2024-03-07

Completion Date

2026-08-03

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

DRUG

AMG 355

Short-term intravenous (IV) infusion

DRUG

Pembrolizumab

Short-term IV infusion

Locations (25)

City of Hope National Medical Center

Duarte, California, United States

Alliance for Multispecialty Research - Kansas City

Merriam, Kansas, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

St Vincents Hospital Sydney

Darlinghurst, New South Wales, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Institut Bergonie

Bordeaux, France

Gustave Roussy

Villejuif, France

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warsaw, Poland

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Istituto Oncologico della Svizzera Italiana

Bellinzona, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan