Alpha DaRT combined with chemotherapy for locally advanced and metastatic pancreatic cancer
A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
This tests whether adding Alpha DaRT (an implanted alpha-radiation device) to standard chemotherapy helps people with locally advanced or metastatic pancreatic adenocarcinoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Alpha Tau Medical LTD. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 15 sites (Gilbert, Arizona and 14 other locations) |
| Trial ID | NCT06698458 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label, multicenter interventional study enrolling up to 30 participants in two cohorts (locally advanced and metastatic disease). Eligible patients start mFOLFIRINOX or gemcitabine/nab‑paclitaxel and undergo Alpha DaRT source placement during the first four chemotherapy cycles. The primary objective is to measure safety of the implanted Alpha DaRT device by tracking device-related adverse events graded by CTCAE v5; secondary outcomes include overall and progression-free survival, pain control, and rate of surgical resection in the locally advanced cohort. Target lesions must be measurable (≤5 cm) and technically amenable to interstitial implantation, and patients require ECOG 0–2 and standard laboratory eligibility.
Who should consider this trial
Good fit: Ideal candidates are adults with newly diagnosed, histologically confirmed locally advanced inoperable or metastatic pancreatic adenocarcinoma, a measurable tumor ≤5 cm that is amenable to implantation, ECOG 0–2, life expectancy >6 months, and laboratory values within the trial's specified limits.
Not a fit: Patients unlikely to benefit include those with resectable disease, lesions not technically suitable for implantation, poor performance status, very limited life expectancy, or significant lab abnormalities that make them ineligible for the device or chemotherapy.
Why it matters
Potential benefit: If successful, the combination could improve local tumor control, relieve pain, and increase the chance that some patients can undergo surgical resection.
How similar studies have performed: Alpha-emitting DaRT is a novel interstitial radiotherapy with promising early-phase results in other solid tumors, but evidence in pancreatic cancer is limited and largely investigational.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gilbert, Arizona and 14 other locations
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (Recruiting)
- City of Hope — Goodyear, Arizona, United States (Not_yet_recruiting)
- Honor Health — Scottsdale, Arizona, United States (Recruiting)
- Cedars-Sinai — Los Angeles, California, United States (Not_yet_recruiting)
- Advent Health Cancer Institute — Orlando, Florida, United States (Not_yet_recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Bassett Healthcare Network — Cooperstown, New York, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Lenox hill Hospital — New York, New York, United States (Not_yet_recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- Texas Oncology — Houston, Texas, United States (Not_yet_recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Not_yet_recruiting)
- University Cancer and Diagnostic — Houston, Texas, United States (Recruiting)
- Jewish General Hospital — Montreal, Quebec, Canada (Not_yet_recruiting)
- Hadassah Ein Kerem — Jerusalem, Israel (Recruiting)
Study contacts
- Study coordinator: Liron Dimnik
- Email: LironD@alphatau.com
- Phone: +972-2-3737-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.