ENACT
Research type
Research Study
Full title
A Phase 2 study to investigate the efficacy and safety of Acoustic Cluster Therapy with modified FOLFIRINOX in patients with locally advanced pancreatic cancer
IRAS ID
1011680
Contact name
Lucy Wabakken
Contact email
Sponsor organisation
EXACT Therapeutics AS
Eudract number
2025-520750-11
Clinicaltrials.gov Identifier
Research summary
The experimental procedure is called ‘Acoustic Cluster Therapy’, abbreviated to ‘ACT’. ACT is added to routine chemotherapy with mFOLFIRINOX. This chemotherapy is commonly used to treat pancreatic cancer, and is a combination of the drugs leucovorin, 5 fluorouracil, irinotecan and oxaliplatin, ‘m’ means modified because some of the drugs are given in lower doses to reduce side effects.
The experimental procedure ACT will be performed during the chemotherapy treatment.
ACT is made up of an experimental drug called ‘PS101’ which is a liquid that contains tiny bubbles. After PS101 is given, ultrasound (a non invasive procedure, usually used to get a picture of the internal organs or babies in the womb, using sound waves) is applied. The ultrasound device used in the study is also considered experimental because the computer software and the probe (the part of the device that touches the skin and produces the sound waves) are different to ultrasound machines for normal clinical use.
PS101 is given by an injection into a vein in the arm (intravenously, abbreviated to ‘IV’) and travels throughout the body in the blood. The ultrasound probe is placed on the abdomen and ultrasound is then applied over the area where the tumour is. The ultrasound traps PS101 bubbles in tumour blood vessels and makes the bubbles vibrate, leading to ‘leakier’ vessels. This may increase the amount of chemotherapy that gets from the blood into the tumour tissue which could lead to more tumour cells being killed.
This study will look at the safety of ACT performed during chemotherapy and what effects it has on the participant and their cancer. Tests in laboratory models and with several different chemotherapy treatments have shown that tumour cells can be killed more effectively when ACT is given with chemotherapy, compared with the chemotherapy alone.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0127
Date of REC Opinion
12 Jun 2025
REC opinion
Further Information Favourable Opinion