ASP1948 in Combination with Nivolumab in Subjects with Solid Tumours
Research type
Research Study
Full title
A Phase 1b Study of ASP1948, Targeting an Immune Modulatory Receptor, as a Single Agent and in Combination with Nivolumab in Subjects with Advanced Solid Tumours
IRAS ID
270649
Contact name
Matthew Krebs
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2018-003873-82
Duration of Study in the UK
3 years, 9 months, 0 days
Research summary
This is a Phase 1b first in man study of ASP1948, targeting a particular cell of the immune system, as a single drug and in combination with Nivolumab in patients with Advanced Solid Tumours. The study will look at the treatment of patients with cancer that cannot be removed through surgery (unresectable) or may have spread (metastasised) to other parts of the body.
In this study, ASP1948 will be given alone or combined with nivolumab. Both ASP1948 and nivolumab will be considered study drugs.
The main purpose of the study is to determine at what dose the study drug (ASP1948 or ASP1948 plus nivolumab) is safe and tolerated and how it is processed in the blood of patients. When the safe dose is identified, it will be used to evaluate if the study treatment cause tumours to shrink in patients. During this period, the study drug will be continuously assessed to determine if it is safe and tolerated by patients taking it.
ASP1948 is an experimental drug, this is the first time it is being tested in humans. The drug has not been approved by the Medicine and Healthcare Products Regulatory Agency (MHRA) or any other regulatory agency, for the treatment of any disease or any type of tumour.
Nivolumab however has been approved by the MHRA, and other regulatory agencies for use in patients with lung cancer, skin cancer, kidney cancer, certain head, neck and other cancers.Approximately 474 participants will take part in this study at approximately 110 sites in North America, Europe and Asia. UK participants will not take part at the Escalation phase of the study, in which aproximately 54 participants will be enrolled.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0599
Date of REC Opinion
3 Mar 2020
REC opinion
Further Information Favourable Opinion