MedTrace Logo

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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-11-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ASP1948

Intravenously (IV)

DRUG

nivolumab

Intravenously (IV)

DRUG

pembrolizumab

Intravenously (IV)

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Astellas Pharma Global Development, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2023-03-27
Completion
2023-03-27
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Italy
  • Japan
  • Portugal
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03565445 on ClinicalTrials.gov