ACCURACY STUDY
Research type
Research Study
Full title
ACCURACY study: a Phase 2, Open-Label, Single-Arm, Multi-Centre Study of AL101 in Patients with Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
IRAS ID
262551
Contact name
Robert Metcalf
Contact email
Sponsor organisation
Ayala Pharmaceuticals, Inc.
Eudract number
2019-000309-64
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
110,405, IND Number
Duration of Study in the UK
1 years, 8 months, 17 days
Research summary
Adult patients with adenoid cystic carcinoma (ACC) that is newly diagnosed, has come back or did not get better with their last therapy and who have alterations in a group of genes called Notch will be recruited for the study.
Notch is a gene present in normal cells but when there are changes or mutations in this gene, it causes the cells to behave differently and enables them to form tumours. Too much Notch activity induces cells to divide out of control.
AL101 is an experimental drug and we are studying AL101 to find out what its side effects are and if it works for ACC. AL101 works by blocking excessive Notch activity and induces the death of the tumour cells. This study is designed to test whether this is true.
If the patient consents to take part and the study doctor decides they can be in the study, AL101 will be given 4 mg intravenously (IV) weekly. The infusion will take approximately 1 hour.
The patient will be treated using this schedule:
- An infusion once a week on Days 1, 8, 15 and 22 of each 28-day cycle.
- Cycle 1 Day 1 is considered the first time the patient will get the AL101 infusion.
- Every 28 days is considered study-cycle.The patient will also undergo regular study assessments and procedures including radiographic imaging to understand if the tumour is responding to therapy with AL101. If the drug is killing the tumour cells, then the size of the tumour will decrease.
All the study assessments and procedures including AL101 administration will place at the study hospital
Approximately 36 volunteers will take part in this study globally.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0660
Date of REC Opinion
24 Oct 2019
REC opinion
Favourable Opinion