PCD4989g Phase 1 study in patients with solid tumours
Research type
Research Study
Full title
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MPDL3280A Administered Intravenously as a Single Agent to Patients with Locally Advanced or Metastatic Solid Tumors
IRAS ID
100407
Contact name
Thomas Powles
Sponsor organisation
Genentech Inc
Eudract number
2011-001422-23
Clinicaltrials.gov Identifier
Research summary
This is a phase 1 study of the drug MPDL3280A in patients with advanced or metastatic solid tumours (i.e. tumours that have spread or worsened). This will be the first time that this drug is being used in humans. Patients will be placed into one of eight treatment groups which will be assigned eight different doses of the study drug to find out which is the best dose to use for treatment. The safety and tolerability of the study drug will also be assesssed. The group a patient is placed into depends on which group is open at that time. If the total number of patients in a treatment group has been reached, the patient may be asked to wait until the next treatment group is open. One patient at a time will be enrolled in the lowest dose goup (minimum of 3 patinets) to determine safety before enrolling patients in subsequent higher dose groups. Patients will receive the study drug by intravenous infusion every 3 weeks. If their tumour doesn't grow and they are tolerating the study drug, they will continue to receive it for up to 12 months. Approximately 181-328 patients will take part in this study at approximately 20 study centres around the world.
REC name
London - Central Research Ethics Committee
REC reference
12/LO/0456
Date of REC Opinion
1 Jun 2012
REC opinion
Further Information Favourable Opinion