NCT03889275

A Study of MEDI5395 in Combination With Durvalumab in Participants With Select Advanced Solid Tumors

An Open-label Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

Summary

The reason for the study is to find out if MEDI5395 and durvalumab will work and be safe for the treatment of solid tumors.

Detailed description

This is an Phase 1, first-in-human, open-label, dose-escalation, and dose-expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary efficacy of MEDI5395 in combination with durvalumab in participants with selected advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	MEDI5395	Participants will receive multiple dose levels of MEDI5395 over several days as stated in arm description.
BIOLOGICAL	Durvalumab	Participants will receive IV infusion of durvalumab as stated in arm description.

Timeline

• Start date: 2019-10-24
• Primary completion: 2021-11-19
• Completion: 2022-12-12
• First posted: 2019-03-26
• Last updated: 2023-02-21

Locations

10 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study