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A Study of ASP1951 in Subjects With Advanced Solid Tumors

NCT03799003 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-11-01

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1951 when administered as a single agent and in combination with pembrolizumab; and determine the recommended phase 2 dose (RP2D) of ASP1951 and/or maximum tolerated dose (MTD) when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the anti-tumor effect of ASP1951 when administered as a single agent and in combination with pembrolizumab.

Conditions

Interventions

DRUG

ASP1951

Intravenously (IV)

DRUG

pembrolizumab

Intravenously (IV)

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Astellas Pharma Global Development, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2023-07-06
Completion
2023-07-06
FDA Drug
Yes

Countries

  • United States
  • Canada
  • South Korea
  • Taiwan

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 NCT03799003 on ClinicalTrials.gov