Recruiting
Phase 2

ACT with Chemotherapy

Sponsor:

EXACT Therapeutics AS

Code:

NCT06850623

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acoustic Cluster Therapy

Modified FOLFIRINOX

Study Details

Brief 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.

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Study ID

NCT06850623

Start date

Jun 19, 2025

Status verified date

Mar, 2026

Completion date

Jul 15, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acoustic Cluster Therapy (ACT) with mFOLFIRINOX

Interventions

Acoustic Cluster Therapy

Drug: PS101; Device: Ultrasound

Modified FOLFIRINOX

Chemotherapy

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Locations

HonorHealth Research Institute

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Lu Study Coordinator

(+1) (480) 323 1364clinicaltrials@honorhealth.com, lzhao@honorhealth.com

Principal Investigator:

Erkut Borazanci, MD

Stanford Cancer Center Palo Alto

Recruiting

Stanford, California, United States, 94305

Contacts

Britney Williams

650-736-3688bw718@stanford.edu

Isabel Leonio ( Study Coordinator)

ileonio@stanford.edu

Principal Investigator:

Pejman Ghanouni, MD:PhD

Beth Israel Deaconess Medical Center - Division of Hematology/Oncology

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Selma Sinanovic Study Coordinator

+1 617-975-7411ssinanov@bidmc.harvard.edu

Principal Investigator:

Andrea Bullock, MD

Henry Ford Centre

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Christina Vu, Study Nurse

+1 313-556-8107cvu1@hfhs.org

Principal Investigator:

Maria Diab, MD

Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Babar Bashir, MD

(215) 955-4279Babar.Bashir@jefferson.edu

Priscilla Machado -Sub Investigator, MD, FAIUM

(215) 955-4279priscilla.machado@jefferson.edu

Principal Investigator:

Babar Bashir, MD

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Paul Renz, DO

+1-412-359-3400paul.renz@ahn.org

Linda Kernrick (Study Coordinator)

linda.kernick@ahn.org

Principal Investigator:

Paul Renz, DO

Brown University Cancer Institute

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Alexander Raufi, MD

+1 (844) 222-2881ARaufi2@brownhealth.org

Lindsey Cavanagh Study Nurse

lcavanagh@brownhealth.org

Principal Investigator:

Alexander Raufi, MD

More Information

Sponsor

EXACT Therapeutics AS

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Keywords

  • pancreatic cancer
  • PS101
  • ultrasound
  • microbubbles
  • Pancreatic Ductal Carcinoma
  • locally advanced pancreatic cancer
  • first line treatment
  • chemotherapy
  • Acoustic Cluster Therapy
  • mFOLFIRINOX

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by EXACT Therapeutics AS on 2026-04-03.