Locally Advanced Pancreatic AdenocarcinomaPhase 2ENACTNCT06850623
Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
A Phase 2 study testing Acoustic Cluster Therapy and Modified FOLFIRINOX in people with Locally Advanced Pancreatic Adenocarcinoma, run by EXACT Therapeutics AS at 10 sites in 2 countries.
Trial summary
The purpose of the study is to assess the efficacy and safety of Acoustic Cluster Therapy (ACT) when given in addition to chemotherapy for treatment of Locally Advanced Pancreatic Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Adenocarcinoma
- What is being tested?
- Acoustic Cluster Therapy and Modified FOLFIRINOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 19 Jun 2025to 15 Jul 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Not deemed suitable for primary curative surgery and have radiographic and pathological disease consistent with inoperable LAPC or borderline resectable pancreatic cancer.
- Suitable to receive treatment with mFOLFIRINOX according to the Investigator's assessment.
Who cannot join
- Any prior anti-cancer treatment for pancreatic cancer (e.g. chemotherapy, surgery, radiation). Palliative bypass procedure and bile duct stenting are allowed.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Beth Israel Deaconess Medical Center - Division of Hematology/Oncology
Boston, Massachusetts, 02215
Selma Sinanovic Study Coordinator, +1 617-975-7411, ssinanov@bidmc.harvard.edu
Andrea Bullock, MD
- Recruiting
Henry Ford Centre
Detroit, Michigan, 48202
Christina Vu, Study Nurse, +1 313-556-8107, cvu1@hfhs.org
Maria Diab, MD
- Recruiting
Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Babar Bashir, MD, (215) 955-4279, Babar.Bashir@jefferson.edu
Priscilla Machado -Sub Investigator, MD, FAIUM, (215) 955-4279, priscilla.machado@jefferson.edu
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Paul Renz, DO, +1-412-359-3400, paul.renz@ahn.org
Linda Kernrick (Study Coordinator), linda.kernick@ahn.org
- Recruiting
Brown University Cancer Institute
Providence, Rhode Island, 02906
Alexander Raufi, MD, +1 (844) 222-2881, ARaufi2@brownhealth.org
Lindsey Cavanagh Study Nurse, lcavanagh@brownhealth.org
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Lu Study Coordinator, (+1) (480) 323 1364, clinicaltrials@honorhealth.com, lzhao@honorhealth.com
Erkut Borazanci, MD
- Recruiting
Stanford Cancer Center Palo Alto
Stanford, California, 94305
Britney Williams, 650-736-3688, bw718@stanford.edu
Isabel Leonio ( Study Coordinator), ileonio@stanford.edu
United Kingdom3 sites, 3 recruiting
- Recruiting
CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital
Cambridge, Cambridge, CB2 0QQ
Emma Wong Team Co-Lead for Aerodigestive, HPB, Head & Neck Trials Team, +44(0)1223 216083, emma.wong1@nhs.net
Joanne Mayhew Research Nurse, +44(0)1223 216083, joanne.mayhew1@nhs.net
- Recruiting
Gary Weston Centre- Imperial College Healthcare- Du Cane Road
Hammersmith, London, W12 0HS
Richard Senior Clinical Research Practitioner, +44 (0)203 313 8367, richard.elliott2@nhs.net
Harpreet Wasan, Professor: MBBS:MRCP
- Recruiting
The Royal Marsden- Downs Road
Sutton, Surrey, SM2 5PT
Senior Clinical Trial Coordinator, +44 (0)20 3186 5541, gitrials@rmh.nhs.uk
Hazel Lotte Principal Investigator, gitrials@rmh.nhs.uk
About this study
Official 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
The purpose of the study is to assess the efficacy and safety of Acoustic Cluster Therapy (ACT) when given in addition to chemotherapy for treatment of Locally Advanced Pancreatic Cancer.
Read the detailed description
Patients with Locally Advanced Pancreatic Cancer who have not received prior treatment to their pancreatic cancer will receive ACT treatment (the drug PS101 and ultrasound application to the tumor) with up to eight 2-week cycles of modified FOLFIRINOX chemotherapy.
ACT treatment will be given on Day 1 of each cycle of chemotherapy. Patients' well-being and side effects will be assessed at the same visits. The objective efficacy of the treatment will be assessed by CT scans every 8 weeks.
- Being tested
- Acoustic Cluster Therapy, Modified FOLFIRINOX
- Keywords
- pancreatic cancer, PS101, ultrasound, microbubbles, Pancreatic Ductal Carcinoma, locally advanced pancreatic cancer, first line treatment, chemotherapy, Acoustic Cluster Therapy, mFOLFIRINOX
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Pancreatic Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic Cluster TherapyCombination product
Drug: PS101; Device: Ultrasound
Modified FOLFIRINOXDrug
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Acoustic Cluster Therapy (ACT) with mFOLFIRINOX | Experimental | Not described Receives: Combination Product: Acoustic Cluster Therapy; Drug: Modified FOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR (Overall response rate), defined as the number of participants with measurable disease at baseline who have a confirmed Complete Response or confirmed Partial Response according to RECIST Version 1.1.
Measured: From baseline to end of treatment (up to Week 24)
Secondary outcomes (4)
Overall summary of TEAEs including number and percentage of participants with at least one TEAE. TEAEs will be summarized by System Organ Class and Preferred Term. TEAEs will be summarized by severity and causality.
Measured: From enrollment up to week 24
Change in maximum tumor diameter and volume summarized as the largest or the smallest percentage change from baseline. Independent central image review based on RECIST 1.1 criteria will be the primary analysis.
Measured: From baseline up to week 24
Median OS and proportion of participants alive at 6 months.
Measured: from baseline to week 24
The proportion of participants becoming eligible for resection as determined by local multidisciplinary team review
Measured: from baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start19 Jun 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EXACT Therapeutics AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850623
- Sponsor's protocol ID
- EX-2-P2-2023
- Acronym
- ENACT
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No