Phase 1 study of MEDI4736 in Subjects With Advanced Solid Tumours
Research type
Research Study
Full title
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects with Advanced Solid Tumors
IRAS ID
137039
Contact name
David Cunningham
Contact email
Sponsor organisation
MedImmune
Eudract number
2012-002206-52
Clinicaltrials.gov Identifier
Research summary
The present study is a Phase I, multi-centre, open label, First-in-Human, study of MEDI4736 to evaluate the safety, tolerability, and anti-tumour activity of MEDI4637 in adult patients with solid tumours.
The purpose of the research study is to establish the safety profile of the medication in patients with advanced solid tumours. This study will also evaluate how much MEDI4736 is in patients’ blood at various times, whether their immune system becomes activated following treatment or their body produces antibodies (proteins produced by the immune system to detect and respond to threats) against MEDI4736, as well as the effect MEDI4736 has on patient’s cancer.
The study medication, MEDI4736 binds to another protein in the body and may prevent cancer growth by helping certain blood cells of the immune system to eliminate the tumour.
The patient population in the dose- escalation part will be patients with advanced cancers who have failed available standard treatments or who are not candidates for standard therapy after that. The study will enrol in total a minimum of approximately 460 participants at approximately 75 study sites in North America, Asia, and Europe. Patients may be expected to participate in the study for up to 12 months.REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/1616
Date of REC Opinion
2 Jan 2014
REC opinion
Further Information Favourable Opinion