NCT06131398

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	AMG 355	Short-term intravenous (IV) infusion
DRUG	Pembrolizumab	Short-term IV infusion

Timeline

• Start date: 2024-03-07
• Primary completion: 2026-05-24
• Completion: 2026-08-03
• First posted: 2023-11-14
• Last updated: 2025-12-22

Locations

25 sites across 11 countries: United States, Australia, Canada, France, Japan, Netherlands, Poland, South Korea, Spain, Switzerland, Taiwan

Regulatory

• FDA-regulated drug study