drugset / Trial / NCT03565445

A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors

NCT03565445 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab and determine the recommended Phase 2 dose (RP2D) of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab. This study will also evaluate the antitumor effect of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab.

Timeline

Start
2018-07-02
Primary completion
2023-03-27
Completion
2023-03-27

Drugs

EvaluationDrugModalityDoseRoute
Subject ASP1948 Unknown 70 mg Intravenous
Subject ASP1948 Unknown 200 mg Intravenous
Subject ASP1948 Unknown 700 mg Intravenous
Subject ASP1948 Unknown 1200 mg Intravenous
Subject ASP1948 Unknown 2000 mg Intravenous
Subject ASP1948 Unknown 3000 mg Intravenous
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous

Indications