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Official Title
A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
Sponsor
Alpha Tau Medical LTD.
Enrollment
30
Timeline
Jun 2025 → Dec 2026
About This Study
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.
Eligibility Criteria
Inclusion Criteria
- 1Histologically 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).
- 2Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion
- 3Target lesion is technically amenable for Alpha DaRT sources implantation.
- 4Measurable lesion per RECIST (version 1.1) criteria
- 5Lesion size ≤ 5 cm in the longest diameter
- 6Interstitial radiation indication validated by a multidisciplinary team.
- 7ECOG Performance Status Scale 0 -2
- 8Life expectancy is more than 6 months
- 9WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
- 10Platelet count ≥60,000/μl
- 11Creatinine ≤1.9 mg/dL
- 12AST and ALT ≤ 2.5 X upper limit of normal (ULN)
- 13INR \< 1.4 for patients not on Warfarin
- 14Age ≥18 years old
- 15Subjects are willing and able to sign an informed consent form
- 16Women 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.
- 17Patients 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
- 1For Cohort 1 only: Borderline unresectable pancreatic cancer, and/or fit for surgical exploration unless patient refuses surgery.
- 2For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.
- 3Known hypersensitivity to any of the components of the treatment.
- 4Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- 5Clinically 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.
- 6Patients 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.
- 7Has a known additional malignancy that is progressing or requires active treatment.
- 8Exceptions 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.
- 9Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
- 10Patients 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.
- 11Volunteers 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.
- 12High probability of protocol non-compliance (in opinion of investigator).
- 13Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after DaRT insertion
- 14Patients who are at high risk of complications from radiation due to genetic conditions/mutations, inflammatory bowel disease, or connective tissue disease.
Locations
15 sites participating in this study
Emory University
Atlanta, Georgia 30308
MD
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Prathab Devaraj, MD
City of Hope
Goodyear, Arizona 85338
Toufic Kachaamy, MD
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →