NCT04484909

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

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

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Borderline Resectable Pancreatic Adenocarcinoma
• Locally Advanced Pancreatic Ductal Adenocarcinoma
• Resectable Pancreatic Ductal Adenocarcinoma
• Stage III Pancreatic Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Hafnium Oxide-containing Nanoparticles NBTXR3	Given IT
RADIATION	Radiation Therapy	Undergo radiation therapy

Timeline

• Start date: 2020-07-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-07-24
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study