STA101JG - STA551 in patients with solid tumours
Research type
Research Study
Full title
A PHASE Ia/Ib OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF STA551 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
IRAS ID
270978
Contact name
Udai Banerji
Contact email
Sponsor organisation
Chugai Pharmaceutical Co., Ltd
Eudract number
2019-003329-11
Duration of Study in the UK
4 years, 8 months, 23 days
Research summary
This is a dose escalation study, testing a drug called STA551 (the study drug) when given on its own and when given with another drug called atezolizumab to patients with locally advanced or metastatic (spread to other places in the body) solid tumours. The study is open-label, meaning the participant, study doctor(s) and research team will know which participant is receiving which treatment/ dose.
A substance called CD137 plays an important role in creating a favourable environment to help our immune system to attack the cancer cells. STA551 is specifically designed to activate CD137 only when cancer cells are present. This characteristic helps lessen the harmful effect that the study drug could have towards healthy cells. In animal studies, STA551 showed potential to stop the cancer cells multiplying and to destroy them. Atezolizumab also affects the immune system, and it is approved to treat adults with certain types of cancer in some countries. STA551 and atezolizumab are expected to potentially work together to treat cancer.
This study has three parts; Part A, Part B and Part C. Participants in Part A will receive STA551, and participants in Part B and C will receive STA551 together with atezolizumab. There will be at most 188 participants within the EU and Japan in Part A, Part B and Part C of this study. Initially, 4 research sites will participate; 2 in Japan and 2 in the UK. Additional sites will be added for Parts B and C.
Participants will receive treatment as IV (intravenous – into the vein) infusions every 3 weeks (21 days) until their cancer is no longer responding to the treatment, they withdraw from the study or are discontinued for another reason.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/0334
Date of REC Opinion
6 May 2020
REC opinion
Further Information Favourable Opinion