Spots Global Cancer Trial Database for NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resectable Pancreatic Cancer

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Trial Identification

Brief Title: NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resectable Pancreatic Cancer

Official Title: Phase I Study of NBTXR3 Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Ductal Adenocarcinoma

Study ID: NCT04484909

Conditions

Borderline Resectable Pancreatic Adenocarcinoma

Locally Advanced Pancreatic Ductal Adenocarcinoma

Resectable Pancreatic Ductal Adenocarcinoma

Stage III Pancreatic Cancer AJCC v8

Interventions

Hafnium Oxide-containing Nanoparticles NBTXR3

Radiation Therapy

Study Description

Brief Summary: To find the recommended dose of NBTXR3 that can be given in combination with radiation therapy to patients with pancreatic cancer. To learn if the dose NBTXR3 found in Part 1 can help to control the disease.

Detailed Description: PRIMARY OBJECTIVE: • To determine the recommended phase II dose (RP2D) of NBTXR3 activated by radiotherapy in subjects with locally advanced or borderline-resectable pancreatic ductal adenocarcinoma. SECONDARY OBJECTIVES: * To evaluate the safety and feasibility of NBTXR3 intratumoral injection activated by radiotherapy in locally advanced or borderline-resectable pancreatic ductal adenocarcinoma * To evaluate the anti-tumor response of NBTXR3 intratumoral injection activated by radiotherapy in subjects with locally advanced or borderline-resectable pancreatic ductal adenocarcinoma * To evaluate time-to-event outcomes in subjects with locally advanced or borderline-resectable pancreatic ductal adenocarcinoma EXPLORATORY OBJECTIVES: * To evaluate the body kinetic profile of intratumorally injected NBTXR3. * To evaluate time to event outcomes for subjects with clinical staging of locally advanced, unresectable disease. * To evaluate resectability conversion rates. * To evaluate surgical outcomes in subjects who undergo surgery after radiation therapy. * To associate radiomic measurements with outcomes. * To evaluate biomarkers of response in subjects treated with NBTXR3/RT. OUTLINE: This is a dose-escalation study of NBTXR3. Patients receive NBTXR3 intratumorally (IT) on day 1. Patients then undergo 15 fractions of intensity modulated radiation therapy (IMRT) between days 15-43 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 month and then every 3 months for up to 1 year.