ASPEN-04
Research type
Research Study
Full title
A PHASE 2 STUDY OF ALX148 IN COMBINATION WITH PEMBROLIZUMAB AND CHEMOTHERAPY IN PATIENTS WITH ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA (ASPEN-04)
IRAS ID
293504
Contact name
Kevin Harrington
Contact email
Sponsor organisation
ALX Oncology Inc.
Eudract number
2020-004662-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Advances using cancer treatment that helps the immune system fight cancer and improve the patient’s own adaptive and innate immune systems have led to improved antitumour therapy. Myeloid cells (blood cells), are functionally diverse, and are essential for the normal function of the adaptive and innate immune systems both of which are important parts of anticancer immunity. It has been shown that tumour cells can manipulate the myeloid compartment 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 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 white blood cells to cancer cells and spare normal cells.
The purpose of this research study is to study the effectiveness of the study drug, ALX148, in combination with pembrolizumab and chemotherapy for treating head and neck cancer. The study will also assess the safety and tolerability of ALX148 with pembrolizumab and chemotherapy, to document the levels of ALX148 in the blood, and to document the effects of ALX148 on the cancer together with pembrolizumab and chemotherapy.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0058
Date of REC Opinion
27 Jul 2021
REC opinion
Further Information Favourable Opinion