ASPEN-03
Research type
Research Study
Full title
A PHASE 2 STUDY OF ALX148 IN COMBINATION WITH PEMBROLIZUMAB IN PATIENTS WITH ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA (ASPEN-03)
IRAS ID
293505
Contact name
Kevin Harrington
Contact email
Sponsor organisation
ALX Oncology Inc.
Eudract number
2020-004093-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Advances utilizing targeted cancer immunotherapies and enhancement of the patient’s own adaptive and innate immune systems have led to improved antitumor therapy. Myeloid cells, are functionally diverse, and are essential for the normal function of the adaptive and innate immune systems both of which are important components of anti-cancer immunity. It has been shown that tumour cells can manipulate the myeloid compartment including CD47- SIRPα interaction in an attempt to evade immune surveillance.
ALX148 is a new investigational drug. ALX148 is a fusion protein (a protein generated by joining parts of two different proteins), which has been shown in animal studies to help the immune system destroy cancer cells. ALXI148 is designed specifically to bind to CD47 and block the “don’t eat me” signal however it lacks an active Fc domain. Therefore, the second required “eat me” signal can be independently and selectively provided by anti-cancer therapeutics that contain an active Fc. By separating the two signals it is possible to selectively direct macrophages to cancer cells and spare normal cells.
In this study participants will either be given ALX148 in combination with pembrolizumab or will receive pembrolizumab alone. The first 6 participants will receive ALX148 in combination with pembrolizumab and will have more study visits to look at how ALX148 levels change over time in detail. The purpose of this “safety lead-in” group of participants is to provide more information about the safety and tolerability of the dose of ALX148 chosen for this study in combination with pembrolizumab. After this first group of participants, they will be randomly assigned to a treatment and they will have a 2:1 chance of receiving ALX148 in combination with pembrolizumab (compared to receiving pembrolizumab alone).REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
21/EM/0046
Date of REC Opinion
4 Jun 2021
REC opinion
Further Information Favourable Opinion