NCT04094506

Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors

A Phase 1, Open-label Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the tolerability, safety and pharmacokinetic profile of ASP1948 in Japanese patients with locally advanced (unresectable) or metastatic solid tumors. This study will also evaluate the antitumor effect of ASP1948.

Detailed description

This study consists of 3 dose levels (1200 milligrams \[mg\], 2000 mg and 3000 mg) and enrollment of subjects into dose level 1200 mg will take place first. Dose level 2000 mg would only be opened if dose level 1200 mg is deemed tolerable. Dose level 3000 mg would only be opened if dose level 2000 mg is deemed tolerable.

Conditions

• Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies

Interventions

Type	Name	Description
DRUG	ASP1948	Intravenous

Timeline

• Start date: 2019-10-30
• Primary completion: 2022-02-02
• Completion: 2022-02-02
• First posted: 2019-09-19
• Last updated: 2024-11-01

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study