Open label trial of H3B-6545 in HER2 negative breast cancer
Research type
Research Study
Full title
A Phase I-II multicenter, open label trial of H3B-6545, a covalent antagonist of estrogen receptor alpha, in women with locally advanced or metastatic estrogen receptor-positive, HER2 negative breast cancer
IRAS ID
245093
Contact name
Tarek Sahmoud
Contact email
Sponsor organisation
H3 Biomedicine Inc.
Eudract number
2018-000570-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
Research Summary:
This is a first-time-in-patient(FTIP)study of H3B-6545 in women with Oestrogen Receptor positive (ER+), HER2 negative (human epidermal growth factor receptor 2), locally advanced, or metastatic breast cancer. The study drug H3B-6545 binds to oestrogen receptors in cells, including tumour cells. The oestrogen receptor can cause cancer cells to grow when it is activated. By binding to oestrogen receptors, H3B-6545 may help stop cancer cells from growing. This study is being done in two phases. Phase I of this study is called ‘dose escalation’ while Phase II is referred to as ‘dose expansion’. The Phase I is designed to find the highest dose of H3B-6545 that did not cause serious side effects which will be used in this population during the Phase 2. UK will only participate in the Phase 2.Phase 2 portion of the study will examine the effectiveness of the dose determined during the Phase 1 part of the study. 80 patients are expected to be enrolled. The first 12 patients enrolled will be included in the food- effect cohort and will be randomly (like flipping a coin) assigned to receive the dose of H3B-6545 in a fed or fasted state. Each patient will then receive the dose in the reverse/untried state. Each treatment cycle is 28 days.
30 patients who have an intact uterus will undergo an assessment using transvaginal ultrasonography (an ultrasound of the vaginal walls to measure the thickness). Fresh tumour tissue sample will be obtained from all patients before the administration of the first dose of H3B-6545 and again in the first week of Cycle2 until at least 15 paired biopsies from patients with and without mutations to their oestrogen receptors alpha; the purpose is to study genetic changes, proteins, or immune cells in your tumour that may be effected by the study drug.
Summary of results:
A copy of the Lay summary of results will be made available on - https://eisaiclinicaltrials.com/REC name
London - Brent Research Ethics Committee
REC reference
18/LO/1240
Date of REC Opinion
9 Oct 2018
REC opinion
Further Information Favourable Opinion