On April 23, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the successful treatment of the first patient in ACAPELLA (Alpha DaRT for CAncer of the PancrEas in Locally advanced Adenocarcinoma), the Company’s European multicenter clinical trial evaluating Alpha DaRT combined with capecitabine for patients with inoperable locally advanced pancreatic ductal adenocarcinoma (LAPC) who have completed first-line mFOLFIRINOX chemotherapy. The procedure was performed at CHU Grenoble Alpes by Pr. Gaël Roth, Lead Investigator of ACAPELLA, and his team, marking the first use of Alpha DaRT for pancreatic cancer in Europe.
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Pancreatic ductal adenocarcinoma is among the most lethal malignancies worldwide. Across Europe, approximately 140,000 new cases are diagnosed annually and nearly 132,000 deaths are recorded each year.¹ Approximately 30% of patients present with locally advanced disease – tumors that have infiltrated critical vascular structures but remain confined without distant metastases, rendering surgery impossible.²ʾ³ This translates to an estimated 42,000 patients in Europe and approximately 4,500 patients in France alone each year, facing a poor survival outlook. While first-line mFOLFIRINOX has extended survival for patients who tolerate it, there is no established standard of care once induction is complete. Intensive chemotherapy cannot be sustained indefinitely, and conversion towards surgical resection with systemic therapy alone remains rare, leaving most patients without a treatment path forward.
Uzi Sofer, CEO of Alpha Tau, remarked: "Over forty thousand Europeans each year are diagnosed with inoperable locally advanced pancreatic cancer, and even if there are some patients who have managed to complete first-line chemotherapy, there remains no established next step, no standard treatment path, and an inevitable progression for the great majority. That is the great unmet need ACAPELLA was designed to address. Together with the ongoing IMPACT multicenter pancreatic cancer trial in the United States, the ACAPELLA trial represents Alpha Tau’s commitment to building a rigorous, global clinical evidence base for intrapancreatic alpha-emitter radiotherapeutics to treat this terrible disease. The timing of this first patient treatment, just ahead of Digestive Disease Week 2026 in Chicago, offers a welcome opportunity to engage with the global GI oncology community about our exciting clinical progress."
Pr. Gaël Roth, MD PhD, Principal Investigator and Professor of Gastrointestinal Oncology, expert in pancreatic cancer at CHU Grenoble Alpes, stated: "Being the first center in Europe offering access to pancreatic cancer treatment with Alpha DaRT, a new innovative device aiming to improve patients’ outcome in such a severe disease, is both a professional honor and a scientific responsibility. The procedure itself is straightforward – Alpha DaRT sources are delivered directly into the pancreatic tumor under real-time endoscopic ultrasound guidance, in a single session, which for patients who have already completed months of intensive chemotherapy is a meaningful advantage. CHU Grenoble Alpes brings together the expertise in endoscopy and GI Oncology with strong activity in clinical and translational research that a study of this kind requires. I am proud that this European effort begins here."
Robert Den, MD, Chief Medical Officer of Alpha Tau, commented: "With the first ACAPELLA treatment, two multicenter trials – one in the US and now one across Europe – are now advancing simultaneously, marking a meaningful inflection point for Alpha DaRT in pancreatic cancer. ACAPELLA targets a precisely defined patient population that has exhausted the maximum benefit available from current systemic options yet remains inoperable, and its embedded immune biomarker program will help us understand how intrapancreatic alpha-emitter therapy potentially reshapes the tumor immune microenvironment – a question with significant implications for the next generation of combination strategies."
About ACAPELLA
ACAPELLA (Alpha DaRT for CAncer of the PancrEas in Locally advanced Adenocarcinoma, Protocol CTP-PANC-04) is a prospective, interventional, open label, single-arm multicenter clinical trial enrolling up to 40 patients with histologically confirmed inoperable locally advanced pancreatic ductal adenocarcinoma. Eligible patients must have received 8 to 12 cycles of first-line mFOLFIRINOX and demonstrated stable disease or tumor response per RECIST v1.1, with a target lesion of 5 cm or less in longest diameter amenable to Alpha DaRT source implantation and an ECOG performance status of 0 to 1.
In the trial, Alpha DaRT sources are delivered directly into the tumor under real-time endoscopic ultrasound guidance. Three days following Alpha DaRT insertion, patients initiate oral capecitabine for two months. Tumor resectability is assessed every two months, and follow-up extends to 12 months after the Alpha DaRT procedure. The trial is to be conducted across multiple centers in France.
The primary objective is to evaluate the safety of Alpha DaRT in combination with capecitabine, with the primary endpoint being the incidence of device-related serious adverse events graded per CTCAE v5.0 criteria. Secondary endpoints include objective tumor response rate (per RECIST v1.1 criteria) at 2, 4, and 6 months; overall survival and progression free survival at 12 months; and the rate of conversion to surgical resectability, including the percentage of patients achieving R0/R1 resection. Exploratory objectives include changes in SUVmax and CA 19-9, patient reported quality of life, and evaluation of treatment-associated changes in the tumor immune microenvironment.
Additional information about the trial can be found at: View Source
(Press release, Alpha Tau Medical, APR 23, 2026, View Source [SID1234664718])