ATTAINMENT
Research type
Research Study
Full title
A modular, multi-arm, first in human trial to evaluate the safety and tolerability of MDX-124 alone and in combination with anti-cancer treatments, in participants with locally advanced, unresectable or metastatic solid malignancies
IRAS ID
1005488
Contact name
Daniel Palmer
Contact email
Sponsor organisation
Medannex Limited
ISRCTN Number
ISRCTN78740398
Clinicaltrials.gov Identifier
Not applicable
Research summary
The aim of this study is to find an effective dose of the study drug (MDX-124) for future studies. The research will look at how safe and well the body copes with the drug before any severe side effects appear (tolerability) and examine how this drug may work with existing forms of treatment available.
The study drug is a molecule involved within the immune system that can specifically bind to a target and activate an immune response (antibody). These antibodies are based on human antibodies (humanised) and have been changed to specifically target a protein called annexin-A1 (ANXA1). All antibodies used will be exactly the same (monoclonal). These are referred to as humanised monoclonal antibodies. The study drug binds to a protein produced by humans and animals called ANXA1.
ANXA1 is a protein produced by various organs in the human body, and has several normal functions, but when over produced is known to play a critical role in how certain cancers behave.
This is the first clinical trial to use the study drug in humans. There are 2 sections (or modules). In Module 1 a set dose of study drug will be given to each participant every 14 days. Dosing will continue until the cancer progresses as indicated by an increase in tumour size and/or the identification of new tumours. Dosing may stop if the participant does not feel well enough to continue or the doctor decides the participant should stop the study. Depending on the information on how well that dose works it is possible that the dose will be increased in the next joining participant. It is expected that 24 participants will join Module 1 of the study to find the effective dose of MDX-124. Module 2 will involve using information on safe and effective doses gained from Module 1 to determine how the study drug works in combination with chemotherapies. Module 2 will recruit 20 more participants.
The results will be used to improve treatments for patients with advanced, unresectable, or metastatic cancers.REC name
London - Central Research Ethics Committee
REC reference
22/LO/0770
Date of REC Opinion
12 Dec 2022
REC opinion
Further Information Favourable Opinion