FiH study of BAY 3547926 in advanced HCC
Research type
Research Study
Full title
A multicenter, open label, non-randomized first-in-human phase 1 dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of BAY 3547926 alone, and in combination, in participants with advanced hepatocellular carcinoma (HCC)
IRAS ID
1010973
Contact name
- -
Contact email
Sponsor organisation
Bayer AG
Research summary
This is an open-label, multicenter Phase 1 first-in-human study of BAY 3547926 to look at safety, how it moves into, through and out of the body, and how well it works in participants with advanced liver cancer.
Participants in this study will take part in one of the 3 different parts of the study. In dose escalation (Part 1) increasing doses of BAY 3547926 will be given to find the dose that is deemed safe and works best for patients with advanced liver cancer. When this dose has been found, BAY 3547926 given alone in Part 2 or given together with other treatments in Part 3 will be further tested in larger groups of patients (dose expansion).
In addition, a sub study will gather information on the distribution of the study treatment in the body, the proportion that binds to the cancer cells, and the resulting radiation at the tumour site.
The study will involve 5 periods which are prescreening (optional), screening, Treatment, Active Follow-Up and Long Term Follow Up.
During the study, the study team will do physical examinations, take blood and urine samples , check vital signs (blood pressure, heart rate and body temperature) , take tumour samples if required , take pictures (scans) of the body to check if the participants’ cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) , ask participants questions about their wellbeing and side effects .
You will receive the study treatment in two consecutive infusions, given through a tube into one of your veins.
Patients may remain on study treatment for a maximum of 4 treatment cycles, but their treatment may be stopped early if they achieve a complete response, if their disease progresses or if the study medication is not well tolerated.REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0840
Date of REC Opinion
5 Feb 2025
REC opinion
Further Information Favourable Opinion