D6060C00002_Phase 1_Advanced Solid Tumors_MED10562
Research type
Research Study
Full title
A Phase 1 Multicenter, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MED10562 in Combination with Immune Therapeutic Agents in Adult Subjects with Advanced Solid Tumors
IRAS ID
228159
Contact name
Hendrik-Tobias Arkenau
Contact email
Sponsor organisation
MedImmune LLC
Eudract number
2016-000177-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 4 months, 1 days
Research summary
Cancer continues to be a major global health burden. There continues to be an unmet need for more effective and less toxic therapies, especially for patients with advanced tumours.
Research has shown that in some patients, cancer and immune cells start to give off signals that stop the body’s immune system from killing the cancer.
MEDI0562,durvalumab and tremelimumab are new experimental drugs being developed to try and help the immune system to prevent or slow down the growth of cancer cells.
The study includes 2 phases, dose escalation (a progressive increase in dose to investigate a maximum tolerated or administered dose) and dose expansion (looking more closely at the safety and tolerability of the drugs), with 2 treatment arms in each phase: MEDI0562/durvalumab combination therapy (Arm A) and MEDI0562/tremelimumab combination therapy (Arm B). The 2nd phase of the study will not begin until Medimmune has determined the safe and tolerable dose from the first phase. Each participant will only be enrolled into one phase of the study.
The study will involve a screening period (approx 28 days), treatment period (until disease progression or any other protocol defined criteria are met) and a follow-up period (approx 3 years).
A number of different tests will need to be done to determine if these drugs work, learn what side effects there might be, how much of each drug is in the blood at various times, the immune system status following treatment, whether the body produces antibodies against these drugs, and what effect these drugs have on cancer. These include tumour biopsies, physical examinations, ECGs, blood and urine tests, as well as CT and MRI scans.
Approximately 404 participants at approximately 75 clinical research sites globally will be enrolled in this study. Entry into the study depends on prior cancer treatments and disease status.REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0087
Date of REC Opinion
30 Aug 2017
REC opinion
Further Information Favourable Opinion