Safety and tolerability study of MP0250
Research type
Research Study
Full title
A phase I multi-centre, open-label, repeated-dose, dose escalation study to assess safety, tolerability and pharmacokinetics of MP0250 in patients with advanced solid tumours
IRAS ID
152873
Contact name
Adrian Harris
Contact email
Sponsor organisation
Molecular Partners AG
Eudract number
2014-000366-21
Research summary
This research study is looking at a new medication, called MP0250. There is evidence in the laboratory that MP0250 is effective in the treatment of cancer. This is the first study of MP0250 in humans and its main purpose is to test its safety and acceptability in patients who have cancer. This study will also examine how the drug is changed by and removed from the body and look for indicators that the drug may be truly effective against cancer. This study will test several different dose levels of the study drug to determine the safety and acceptability of the drug.
Briefly stated, an optimal dose is established as follows: A very low dose of the medication is given to a group of three patients. If these patients experience no unacceptable side effects, another group of three patients gets a higher dose. This is repeated until a dose level is identified which causes unacceptable side effects. The optimal dose level is below that of highest dosing group
This optimal dose is given to 8 or 16 patients to increase understanding of the tolerability and biological activity of the optimal dose.
In this first part of the study each patient will normally get 12 infusions of the study medication.
When all patients have either received 12 infusions or withdrawn from the study prior to the twelfth infusion, an interim analysis will be undertaken to give a preliminary evaluation of safety and biological activity of the study medication.
In the second part of the study, those patients who continue to derive benefit from MP0250 may receive up to 12 further infusions. They might receive even more after a possible protocol amendment.REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1008
Date of REC Opinion
21 Jul 2014
REC opinion
Further Information Favourable Opinion