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Acoustic Cluster Therapy

Phase 2

Locally Advanced Pancreatic Adenocarcinoma | Small molecule | Oncology |Exact Sciences Corporation|Last Updated: Apr 3, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Acoustic Cluster Therapy · 1 trial · 1 indication

Phase 2 1
NCT06850623Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic CancerLocally Advanced Pancreatic Adenocarcinoma
RECRUITING25 Analytics
PHASE2RECRUITING
Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
Locally Advanced Pancreatic Adenocarcinoma
NCT0685062325
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Study Endpoints

Primary Endpoints

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.
From baseline to end of treatment (up to Week 24)

Secondary Endpoints

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.
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.
From baseline up to week 24
Median OS and proportion of participants alive at 6 months.
from baseline to week 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Acoustic Cluster Therapy (ACT) with mFOLFIRINOXEXPERIMENTAL -

Interventions

NameTypeDescription
Acoustic Cluster TherapyCOMBINATION_PRODUCTDrug: PS101; Device: Ultrasound
Modified FOLFIRINOXDRUGChemotherapy
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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 C...

Countries:United StatesUnited Kingdom
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Frequently asked questions about Acoustic Cluster Therapy

What is Acoustic Cluster Therapy used for?

Acoustic Cluster Therapy is an investigational small molecule being studied for the treatment of locally advanced pancreatic adenocarcinoma. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who is developing Acoustic Cluster Therapy?

Acoustic Cluster Therapy is being developed by Exact Sciences Corporation, a company traded on NASDAQ under the ticker EXAS. The company is conducting clinical trials to evaluate the therapy in patients with locally advanced pancreatic cancer.

What phase is Acoustic Cluster Therapy in?

Acoustic Cluster Therapy is currently in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory agencies and is still being evaluated in clinical trials for safety and efficacy.

What clinical trials is Acoustic Cluster Therapy in?

Acoustic Cluster Therapy is being studied in one active Phase 2 clinical trial, identified as NCT06850623. This trial is recruiting 25 participants with locally advanced pancreatic adenocarcinoma and is being conducted in the United States and United Kingdom.

Is Acoustic Cluster Therapy the same as ACT?

Acoustic Cluster Therapy is also referred to by the abbreviation ACT. In clinical trial documentation, the therapy is described as Acoustic Cluster Therapy (ACT) with chemotherapy for the treatment of locally advanced pancreatic cancer.