Jerusalem, Israel, August 31, 2026
Alpha Tau Medical Ltd. has completed patient enrollment in its multicenter IMPACT (Intratumoral Pancreatic Alpha Combination Trial) pilot study evaluating Alpha DaRT® in patients with newly diagnosed, unresectable locally advanced or metastatic pancreatic adenocarcinoma. The company reported that a total of 48 patients have been enrolled across 10 clinical centers in the United States, Canada and Israel, marking an important milestone in the development of its investigational alpha-radiation technology for pancreatic cancer. The study originally planned to enroll 12 patients but was expanded three times in response to strong interest from participating clinicians and patients. IMPACT is evaluating Alpha DaRT as a one-time intratumoral treatment administered alongside standard first-line chemotherapy, with initial study data targeted for early 2027. The results are expected to help inform the design of a planned pivotal study and support Alpha Tau’s broader global pancreatic cancer development program.
Alpha Tau Expands IMPACT Pancreatic Cancer Study
The IMPACT study is designed as a prospective, multicenter, open-label pilot trial investigating the feasibility, safety and efficacy of intratumoral Alpha DaRT in combination with standard-of-care chemotherapy. The enrolled population includes patients with newly diagnosed, histologically confirmed pancreatic adenocarcinoma that is considered inoperable and has not previously received radiation. Participants may have locally advanced or metastatic disease and receive standard chemotherapy throughout the study. Alpha DaRT sources are inserted directly into the primary pancreatic tumor using real-time endoscopic ultrasound (EUS) guidance, allowing the investigational treatment to be delivered locally while systemic chemotherapy continues. The study is being conducted under a U.S. Investigational Device Exemption (IDE) and follows patients for up to six months after enrollment. The repeated expansion of the study reflects the development program’s growing clinical interest. IMPACT was initially designed for 12 patients, but enrollment was subsequently expanded to include a broader patient population and both major first-line chemotherapy approaches used within the protocol. Patients are receiving either modified FOLFIRINOX (mFOLFIRINOX) or gemcitabine plus nab-paclitaxel, also known by the brand name Abraxane. According to Alpha Tau, earlier first-in-human pancreatic cancer studies conducted in Israel and Canada provided safety findings that supported evaluating Alpha DaRT as a one-time addition to full-dose first-line chemotherapy.
Alpha DaRT Targets Pancreatic Tumors With Alpha Radiation
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to deliver highly potent alpha radiation directly within solid tumors. The technology uses sources containing radium-224, whose short-lived radioactive daughter atoms diffuse from the implanted sources into surrounding tumor tissue while releasing high-energy alpha particles. Because alpha particles travel only a relatively short distance in tissue, the approach is intended to concentrate radiation within the tumor while limiting exposure to surrounding healthy tissue. For pancreatic cancer, the sources can be positioned within the tumor using minimally invasive EUS-guided placement, an approach that allows gastroenterology and interventional specialists to access the pancreas without conventional open surgery. The IMPACT program builds on earlier clinical investigations of Alpha DaRT in pancreatic cancer. First-in-human studies conducted at Hadassah Medical Center in Jerusalem and at Canadian institutions generated preliminary evidence regarding feasibility, safety and tumor control. Earlier 2026 presentations reported findings from these studies, including disease-control and overall-survival analyses, providing the clinical foundation for continued development. However, those earlier results and the current IMPACT enrollment milestone should not be interpreted as confirmation of efficacy in a controlled pivotal setting. Alpha DaRT remains investigational for pancreatic cancer, and further clinical evaluation is required to establish its benefit-risk profile.
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IMPACT Data Expected to Guide Pivotal Development
With enrollment now complete, the IMPACT study is moving into patient follow-up and data maturation. The primary objective is to assess the safety of combining Alpha DaRT with chemotherapy by evaluating the incidence, severity and outcomes of treatment-emergent adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. Secondary assessments include overall survival, progression-free survival, pain control and surgical resection rates among patients in the locally advanced cohort. These endpoints are intended to provide a broader assessment of how the localized radiation approach performs when integrated with established systemic treatment. Alpha Tau expects the first IMPACT data to become available in early 2027, with the findings intended to guide the design of a future pivotal study. The company is also developing a broader pancreatic cancer program that includes the ACAPELLA clinical trial in France and a study at the University of Verona in Italy. Together, these studies are intended to expand clinical experience with Alpha DaRT across different treatment settings and healthcare systems. The completion of IMPACT enrollment therefore represents a significant step in Alpha Tau’s pancreatic cancer development strategy. By combining localized alpha-radiation delivery with first-line chemotherapy, the company is investigating whether its technology can address the substantial unmet need faced by patients with unresectable pancreatic cancer. The upcoming 2027 readout will be particularly important for determining whether the encouraging early-stage experience can support advancement into a larger pivotal clinical trial.
Source: Alpha Tau Medical press release
