NCT05685472

MEDI5752 in Japanese Patients With Advanced Solid Tumors.

A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Japanese Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label study evaluate the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor activity of MEDI5752 in Japanese patients with advanced solid solid tumors.

Detailed description

\<Objectives\> Primary Objective: To evaluate the safety and tolerability of MEDI5752 in Japanese subjects with advanced solid tumors. Secondary Objective: To assess the anti-tumor activity and efficacy of MEDI5752. To describe the pharmacokinetics of MEDI5752. Exploratory Objective: To conduct exploratory research into factors that may be predictive of response or may influence the progression of cancer and/or response (efficacy) to MEDI5752. Eligible patients will be administered as a single dose at each Cycle Day1. Each cycle from Cycle 1 has a duration of 21 days. A minimum of 3 and a maximum of 9 evaluable patients will be enrolled in each cohort.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	MEDI5752	Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.

Timeline

• Start date: 2022-12-08
• Primary completion: 2023-08-08
• Completion: 2025-07-29
• First posted: 2023-01-17
• Last updated: 2025-08-08

Locations

2 sites across 1 country: Japan