Alpha Radiation Emitters Device (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

NCT06698458 | Recruiting DMC FDA Device

• 1 other identifier: CTP-PANC-09
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 15

Brief Summary

This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). 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 V5. 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety -Serious adverse events

  The primary endpoint is the incidence of treatment-related Serious Adverse Events (SAEs) graded according to CTCAE v5.0

  From Day 0 ,up to 24 months.

Secondary Outcomes (2)

• Complete or pain response

  30 days and 2 months post-procedure

• Percentage of locally advanced that became surgically resectable

  6 and 24 months

Study Arms (2)

Patients with locally advanced pancreatic adenocarcinoma

EXPERIMENTAL

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.

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Patients with metastatic pancreatic adenocarcinoma

EXPERIMENTAL

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.

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) DEVICE

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

Also known as: DaRT

Patients with locally advanced pancreatic adenocarcinoma; Patients with metastatic pancreatic adenocarcinoma

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (15)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

City of Hope

Goodyear, Arizona, 85338, United States

NOT YET RECRUITING

Honor Health

Scottsdale, Arizona, 85258, United States

RECRUITING

Cedars-Sinai

Los Angeles, California, 90048, United States

NOT YET RECRUITING

Advent Health Cancer Institute

Orlando, Florida, 32804, United States

NOT YET RECRUITING

Emory University

Atlanta, Georgia, 30308, United States

RECRUITING

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Lenox hill Hospital

New York, New York, 10075, United States

NOT YET RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Texas Oncology

Houston, Texas, 75251, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77054, United States

NOT YET RECRUITING

University Cancer and Diagnostic

Houston, Texas, 77089, United States

RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

NOT YET RECRUITING

Hadassah Ein Kerem

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Liron Dimnik

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 20 patients in each cohort for a total of 40 subjects.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: June 17, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-10

Locations

CA (1); IL (1); US (13)