MEDI0562 in Adults with Selected Advanced Solid Tumours
Research type
Research Study
Full title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of MEDI0562 in Adult Subjects with Selected Advanced Solid Tumors
IRAS ID
195654
Contact name
Martin Forster
Contact email
Sponsor organisation
MedImmune LLC, a wholly owned subsidiary of AstraZeneca PLC
Eudract number
2015-004573-33
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
123668, IND
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
An antibody is a natural protein made by the body’s immune system. It binds to other proteins and molecules to fight infection. MEDI0562 (the study medication) is an antibody that is made in the lab. It activates the human OX40 protein. OX40 is involved in activating the immune system. Cancers can be recognised by the immune system and under some circumstances the immune system may control or even eliminate tumours. The main purpose of this study is to determine the best dose of MEDI0562 that is safe and tolerable in participants with advanced solid tumours.\nMale and female patients aged 18 years and older with advanced solid tumours may be eligible to take part and will be enrolled into one of the two parts of the study. The first part will evaluate up to 6 different dose levels of MEDI0562. In the second part, participants will receive one of the dose levels selected from part 1 of the study. It is planned that MEDI0562 will be given either every 2 weeks or every 4 weeks depending on the results from part 1. How long each participant takes the study medication will depend on how they respond to the doses they are given. This study will take place at oncology clinics, within hospital settings.\n
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0093
Date of REC Opinion
22 Apr 2016
REC opinion
Further Information Favourable Opinion