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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06850623Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic CancerPHASE2 RECRUITING 25 — — Jun 19, 2025Jul 15, 2027Apr 3, 202610 United States, United Kingdom
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06850623studyFirstPostDate: changed