NCT05514444

Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)

A Phase 1, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of MK-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.

Conditions

• Advanced/Metastatic Solid Tumors
• Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	MK-4464	MK-4464 administered as an IV infusion every three weeks according to allocation and dose escalation.
BIOLOGICAL	Pembrolizumab	Pembrolizumab 200 mg administered as an IV infusion every three weeks.
DRUG	89Zr-MK-4464	89ZR-MK-4464 administered as an IV infusion on C1D1.

Timeline

• Start date: 2022-09-25
• Primary completion: 2025-09-18
• Completion: 2025-09-18
• First posted: 2022-08-24
• Last updated: 2025-10-09

Locations

6 sites across 4 countries: United States, Canada, Israel, Netherlands

Regulatory

• FDA-regulated drug study