* IAG933 in patients with advanced Mesothelioma & other solid tumors
Research type
Research Study
Full title
An open-label, multi-center, Phase I study of oral IAG933 in adult patients with advanced Mesothelioma and other solid tumors
IRAS ID
301421
Contact name
Matthew Krebs
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-000383-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 9 days
Research summary
The purpose of the study is to find out whether a new medicine called ‘IAG933’ is safe, and benefits people with mesothelioma, or cancers with certain mutations in the Hippo intracellular pathway. New treatments for people with this type of cancer are much needed. IAG933 is a medicine that has not yet been given to people and so this research study is known as a ‘first-in-human study’. Results from laboratory and animal studies show that IAG933 has the potential to also work in humans and so the next important step is to investigate IAG933 in humans.
This study has two parts:
The first part (“escalation”) will determine the highest safe dose of IAG933 and how often it should be given.
In the second part of the study (“expansion”), more people will be treated with IAG933 at the dose decided in the first part of the study. The second part will more closely assess IAG933’s anti-cancer effects.
A small group of participants will be asked to take part in a ‘food effects’ assessment which is to see if food affects the absorption of IAG933.
Participants will be told which dose of IAG933 they will receive, and how often they should take it, at the start of their study participation. All participants will receive IAG933 (there is no placebo or ‘dummy’ medicine). IAG933 is a capsule that you take by mouth.
This study includes a screening period, a treatment period (organised in repeating ‘cycles’ lasting 28 days each), and a follow-up period. Participants will receive study treatment until they experience unacceptable toxicity, progressive disease and/or treatment is discontinued at the discretion of the study doctor or the participant themselves. Assessments will include things such as: physical examinations, blood and urine samples, tumour and skin biopsies, scans, heart monitoring, kidney function tests.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0190
Date of REC Opinion
21 Sep 2021
REC opinion
Further Information Favourable Opinion