Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer (ENACT)

March 30, 2026 updated by: EXACT Therapeutics AS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Cambridge
      • Cambridge, Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital
        • Contact:
          • Emma Wong Team Co-Lead for Aerodigestive, HPB, Head & Neck Trials Team
          • Phone Number: +44(0)1223 216083
          • Email: emma.wong1@nhs.net
        • Contact:
        • Principal Investigator:
          • Kiran Purushothaman, MD
    • London
      • Hammersmith, London, United Kingdom, W12 0HS
        • Recruiting
        • Gary Weston Centre- Imperial College Healthcare- Du Cane Road
        • Contact:
        • Principal Investigator:
          • Harpreet Wasan, Professor: MBBS:MRCP
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden- Downs Road
        • Contact:
          • Lucy Scott Senior Clinical Trial Coordinator
          • Phone Number: +44 (0)20 3186 5541
          • Email: Lucy.Scott@rmh.nhs.uk
        • Contact:
        • Principal Investigator:
          • Hazel Lote, MD
  • United States
    • Arizona
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Cancer Center Palo Alto
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pejman Ghanouni, MD:PhD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center - Division of Hematology/Oncology
        • Principal Investigator:
          • Andrea Bullock, MD
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Centre
        • Principal Investigator:
          • Maria Diab, MD
        • Contact:
          • Christina Vu, Study Nurse
          • Phone Number: +1 313-556-8107
          • Email: cvu1@hfhs.org
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
        • Principal Investigator:
          • Babar Bashir, MD
        • Contact:
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
        • Principal Investigator:
          • Paul Renz, DO
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • Brown University Cancer Institute
        • Principal Investigator:
          • Alexander Raufi, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

• Any prior anti-cancer treatment for pancreatic cancer (e.g. chemotherapy, surgery, radiation). Palliative bypass procedure and bile duct stenting are allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acoustic Cluster Therapy (ACT) with mFOLFIRINOX
Combination product: Acoustic Cluster Therapy
Drug: PS101; Device: Ultrasound
Drug: Modified FOLFIRINOX
Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: From baseline to end of treatment (up to Week 24)
From baseline to end of treatment (up to Week 24)

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: From enrollment up to week 24
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.
Time Frame: From baseline up to week 24
From baseline up to week 24
Median OS and proportion of participants alive at 6 months.
Time Frame: from baseline to week 24
from baseline to week 24
The proportion of participants becoming eligible for resection as determined by local multidisciplinary team review
Time Frame: from baseline to week 24
from baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EXACT Therapeutics AS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

July 15, 2027

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-2-P2-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Locally Advanced Pancreatic Adenocarcinoma

Clinical Trials on Acoustic Cluster Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe