GO40311 Phase Ia/b study of BTRC4017A in HER2-Expressing Cancers
Research type
Research Study
Full title
A PHASE Ia/b, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF BTRC4017A ADMINISTERED INTRAVENOUSLY AS A SINGLE AGENT AND IN COMBINATION WITH TRASTUZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HER2-EXPRESSING CANCERS
IRAS ID
295189
Contact name
Simon Lord
Contact email
Sponsor organisation
Genentech Inc.
Eudract number
2019-004596-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, days
Research summary
Breast and gastric/gastro-oesophageal junction cancers are some of the most common malignancies. Despite established agents and therapies providing benefits to patients, these indications have a poor prognosis.
BTRC4017A is an antibody. Antibodies are components of the immune system that attach to specific targets. BTRC4017A has been engineered to attach to cancer cells with HER2 on the surface and T-cells. T-cells are a part of the immune system that normally perform tasks such as killing virus infected cells. BTRC4017A has been designed to direct T-cells to kill cancer cells instead. BTRC4017A may work by directing the body’s immune system to kill cancer cells that express HER2 on the surface.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of BTRC4017A and will make a preliminary assessment of the anti-tumour activity of BTRC4017A when administered as a single agent and in combination with trastuzumab in patients with locally advanced or metastatic HER2-expressing cancers. BTRC4017A will be administered via intravenous infusion.
Patients will be enrolled in either a dose-escalation or a dose-expansion stage. The dose-expansion stage will start when a dose level that has been determined to be safe during the dose-escalation stage is confirmed.
About 213-521 patients will take part in this study, for up to 12 months (having approx. 33-36 site visits) if they are tolerating and benefiting from BTRC4017A.
CT/MRI/ECHO/MUGA scans, blood samples, and tumour biopsies are some of the procedures on this study, which is sponsored by Genentech, Inc.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0183
Date of REC Opinion
14 Oct 2021
REC opinion
Further Information Favourable Opinion