A Phase I study of GBR 1302 in HER2 positive cancers
Research type
Research Study
Full title
A phase 1, first-in-man, multicenter, open-label, dose-escalation study of single-agent GBR 1302 in subjects with HER2 positive cancers
IRAS ID
185264
Contact name
Richard Wilson
Contact email
Sponsor organisation
Glenmark Pharmaceuticals S.A.
Eudract number
2015-002926-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Cancers figure among the leading causes of morbidity and mortality worldwide.
Human epidermal growth factor receptor (HER2) is detectable in several of the most common human solid tumours. Approval of HER2 directed drugs offer treatment options for patients with HER2-positive breast cancer. Treatment options for other HER2-positive tumours are still limited. Most patients with HER2-positive cancers eventually develop resistance and progressive disease on available HER2-directed therapies. Consequently, there is a high medical need and development of additional therapeutic options for these patients is warranted.
GBR 1302 is an antibody with anti-HER2 specificity. GBR 1302 binds to both T lymphocytes and the HER2 antigen on tumour cells, thereby killing the bound tumour cells. The unique mode of action of GBR 1302 holds potential for superior antitumour activity in HER2-positive tumours.
Part 1 of this study is ongoing and will determine the safety profile and maximum tolerated dose (MTD) of GBR 1302.
In Part 2 (in which the UK will participate) patients with HER2-positive cancer types will be treated with GBR 1302 monotherapy at the MTD; the study will further determine the safety, tolerability, and preliminary clinical activity of GBR 1302.
GBR 1302 will be administered by IV infusion on Days 1 and 15 of each 28-day treatment cycle. Participants must be hospitalized for 48 hours after the end of the first and second administrations of GBR 1302. In the absence of any safety concerns subsequent cycles may be administered in the outpatient setting.
Participants will attend the clinic for screening, 8 visits during cycles 1 and 2 (6 in subsequent cycles), and follow up visits. Procedures will include review of medical history and adverse events, vital signs, blood and urine tests (inc pregnancy), ECG, ECHO, CT/MRI scans and physical exams.
Participants will continue until disease progression, occurrence of unacceptable toxicity or until the participant wishes to discontinue treatment.REC name
HSC REC A
REC reference
17/NI/0206
Date of REC Opinion
8 Nov 2017
REC opinion
Favourable Opinion