Recruiting

Alpha DaRT & Chemotherapy

Sponsor:

Alpha Tau Medical LTD.

Code:

NCT06698458

Conditions

Pancreatic Cancer

Pancreatic Adenocarcinoma

Metastatic Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Study Details

Brief summary:

This is a multi-center clinical study enrolling up to 50 participants. The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V6. The secondary objectives of the study are to:

  • Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival.
  • Assess pain control
  • Assess rate of surgical resection in Cohort 1.

Conditions

Pancreatic Cancer

Pancreatic Adenocarcinoma

Metastatic Pancreatic Cancer

Study ID

NCT06698458

Start date

Jun 17, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically and/or cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and/or cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2).
  • Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion
  • Target lesion is technically amenable for Alpha DaRT sources implantation.
  • Measurable lesion per RECIST (version 1.1) criteria
  • Lesion size ≤ 5 cm in the longest diameter
  • Interstitial radiation indication validated by a multidisciplinary team.
  • ECOG Performance Status Scale 0 -2
  • Life expectancy is more than 6 months
  • WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
  • Platelet count ≥60,000/μl
  • Creatinine ≤1.9 mg/dL
  • AST and ALT ≤ 2.5 X upper limit of normal (ULN)
  • INR < 1.4 for patients not on Warfarin
  • Age ≥18 years old
  • Subjects are willing and able to sign an informed consent form
  • Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after initiation of Alpha DaRT therapy.
  • Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.

Exclusion Criteria:

  • For Cohort 1 only: Borderline unresectable pancreatic cancer, and/or fit for surgical exploration unless patient refuses surgery.
  • For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.
  • Known hypersensitivity to any of the components of the treatment.
  • Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
  • Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
  • Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
  • Has a known additional malignancy that is progressing or requires active treatment.

Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.

  • Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
  • Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.
  • Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
  • High probability of protocol non-compliance (in opinion of investigator).
  • Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after DaRT insertion
  • Patients who are at high risk of complications from radiation due to genetic conditions/mutations, inflammatory bowel disease, or connective tissue disease.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients with locally advanced pancreatic adenocarcinoma

Patients will begin mFOLFIRINOX or Gemcitabine/Abraxane treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.

experimental: Patients with metastatic pancreatic adenocarcinoma

Patients will begin mFOLFIRINOX or Gemcitabine/Abraxane treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

DaRT source will be inserted using endoscopy into the tumor. The sources release by recoil into the tumor short-lived alpha-emitting atoms

Primary outcome measure

  • Safety -Serious adverse events [ Time Frame: From Day 0 ,up to study termination ]

Central Contacts and Locations

Central contacts

Liron Dimnik

+972-2-3737-7000LironD@alphatau.com

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Prathab Devaraj, MD

Prathab.Devaraj@bannerhealth.com

Angel Tameron

480-256-3311BMDACCStudyStartup@bannerhealth.com

Honor Health

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Erkut Borazanci, MD

eborazanci@honorhealth.com

Amy Malenesk

amalensek@honorhealth.com

Emory University

Recruiting

Atlanta, Georgia, United States, 30308

Bassett Healthcare Network

Recruiting

Cooperstown, New York, United States, 13326

Contacts

Timothy Korytko, MD

607-547-3089timothy.korytko@bassett.org

Peggy Cross

peggy.cross@bassett.org

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Gonda Tamas Adam, MD

Tamas.Gonda@nyulangone.org

NYU NYU

212-263-6165ct.gov@nyulangone.org

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Rafi Kabarriti, MD

rkabarri@montefiore.org

Rikin Gandhi

rikin.gandhi@einsteinmed.edu

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77054

Contacts

Benjamin Leon Musher, MD

blmusher@bcm.edu

Monica Francois

713-798-4667monica.francois@bcm.edu

University Cancer and Diagnostic

Recruiting

Houston, Texas, United States, 77089

Contacts

Mark D'Andrea, MD

936-223-1379mmmeead@aol.com

Jo Ann Ramirez

9362231379jramirez@universitycancercenters.com

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada

Contacts

Corey Miller, MD

514-340-8144corey.miller@mcgill.ca

Chadi Zakaria, Ph.D.

514-340-8222 Ext 23293chadi.zakaria.ccomtl@ssss.gouv.qc.ca

More Information

Sponsor

Alpha Tau Medical LTD.

Last update posted

Aug 27, 2026

Last verified

Oct, 2025

Keywords

  • Alpha radiation
  • pancreatic cancer
  • Pancreatic Adenocarcinoma
  • Unresectable Pancreatic Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alpha Tau Medical LTD. on 2026-08-27.