Study of RO7566802 and Atezolizumab in solid tumours
Research type
Research Study
Full title
A PHASE I, OPEN-LABEL, MULTICENTER, DOSE- ESCALATION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7566802 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
IRAS ID
1008627
Contact name
Jenn Pangilinan
Contact email
Sponsor organisation
Genentech Inc.
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
NCT0603144
Research summary
This is a Phase I, open-label, multicenter, dose-escalation and expansion study sponsored by Genentech Inc. This study is testing a drug called RO7566802, which is being developed for the treatment of certain cancers in combination with another treatment, Atezolizumab. Atezolizumab is approved in some countries for the treatment of a number of different types of cancer. Thus, the addition of RO7566802 in combination with atezolizumab might provide further benefit.
The purpose of this study is to evaluate the experimental drug RO7566802, meaning health authorities have not approved RO7566802 alone or in combination with atezolizumab for the treatment of cancer. RO7566802 will be tested for the first time in humans to find out if it is safe and to understand the way the body processes the drug. This clinical trial will study RO7566802 alone and in combination with atezolizumab in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies.
The study consists of a screening period of up to 28 days, a treatment period, a minimum follow-up period of 90 days after treatment, and survival follow-up. Patients will be enrolled in two stages based on study criteria: a dose-escalation stage to determine maximum tolerated dose (MTD) or maximum administered dose (MAD) for RO7566802 in combination with atezolizumab and an expansion stage to obtain further data in specific disease areas.
Approximately 120-250 of eligible patients are expected to be enrolled in this study globally.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0101
Date of REC Opinion
21 Jun 2024
REC opinion
Further Information Favourable Opinion