EXACT Therapeutics has initiated its Phase 2 ENACT trial, evaluating Acoustic Cluster Therapy (ACT) combined with standard chemotherapy in patients with borderline resectable or unresectable locally advanced pancreatic cancer. The open-label, multi-center trial builds upon positive efficacy and safety data from a Phase 1 trial involving patients with colorectal cancer liver metastases. The trial aims to address the urgent need for improved treatments for pancreatic cancer, a disease with a high mortality rate and limited effective therapies.
This Phase 2 trial is a critical step for EXACT Therapeutics and holds significant implications for pancreatic cancer treatment. The positive Phase 1 results suggest ACT may enhance drug delivery and improve outcomes. If successful, the ENACT trial could validate ACT’s potential to transform the therapeutic landscape for this challenging cancer, offering a new approach to improve the efficacy of existing chemotherapy regimens. It represents a potential breakthrough for patients facing this aggressive and often fatal disease.
The ENACT trial will enroll up to 25 patients across the U.S., U.K., and Europe (ClinicalTrials.gov Identifier: NCT06850623). Initial safety data is anticipated in 2025. The trial’s commencement follows positive final efficacy and safety data from a Phase 1 trial in patients with liver metastases from colorectal cancer.
The initiation of the ENACT trial marks a pivotal moment for EXACT Therapeutics and the development of ACT. Positive results could pave the way for a larger-scale trial and potentially lead to regulatory approval, offering a much-needed new treatment option for patients with advanced pancreatic cancer. The data generated will be crucial in assessing ACT’s potential and determining its future role in cancer care.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
