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

NCT04484909 | Suspended Phase 1 FDA Drug

• 2 other identifiers: 2019-1001NCI-2020-03731
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicities

  Any grade \>= 3 adverse event related to NBTXR3 and/or radiation therapy. Any toxicity (grade \>= 3) that is at least possibly related to study drug (NBTXR3) is a DLT. Adverse events will be scored based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE v 5.0).

  4 weeks after last radiation dose

• Maximum tolerated dose (MTD)

  MTD will be determined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate 30%.

  Up to 1 year

• Recommended phase II dose (RP2D)

  Up to 1 year

Secondary Outcomes (3)

• Determination of the feasibility of NBTXR3 injection in pancreas

  Up to 1 year

• Progression free survival (PFS)

  From NBTXR3 injection to local recurrence, local progression, distant progression, or death from any cause, whichever occurs first, assessed up to 1 year

• Overall survival (OS)

  From NBTXR3 injection to death from any cause or EoS, whichever occurs first, assessed up to 1 year

Other Outcomes (4)

• Presence of hafnium

  Up to 1 year

• Disease control rate

  6 months

• Proportion of locally advanced subjects who undergo surgical resection after receiving NBTXR3/radiation therapy (R3/RT)

  Up to 1 year

Study Arms (1)

Treatment (NBTXR3, radiation therapy)

EXPERIMENTAL

Patients receive NBTXR3 IT on day 1. Patients then undergo 15 fractions of radiation therapy between days 15-43 in the absence of disease progression or unacceptable toxicity.

Other: Hafnium Oxide-containing Nanoparticles NBTXR3; Radiation: Radiation Therapy

Interventions

Hafnium Oxide-containing Nanoparticles NBTXR3 OTHER

Given IT

Also known as: NBTXR3

Treatment (NBTXR3, radiation therapy)

Radiation Therapy RADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Treatment (NBTXR3, radiation therapy)

Eligibility Criteria

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

You may qualify if:

• \. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study 2. Age ≥ 18 years 3. Biopsy proven ductal adenocarcinoma of the pancreas,as defined by the following:
• a. Borderline resectable pancreatic adenocarcinoma (BRPC) has no aortic involvement with at least ONE of the following features: i. Superior mesenteric vein (SMV) or Portal vein (PV) with a tumor interface of ≥ 180° OR short segment occlusion of SMV or PV amenable to reconstruction ii. Superior mesenteric artery (SMA) or celiac axis (CA) with a tumor interface of \< 180° iii. Any degree of hepatic artery interface that is amenable to reconstruction b. Locally advanced pancreatic adenocarcinoma (LAPC) has at least ONE of the following features:
• Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
• Age ≥ 18 years
• Biopsy proven ductal adenocarcinoma of the pancreas,as defined by the following:
• a. Borderline resectable pancreatic adenocarcinoma (BRPC) has no aortic involvement with at least ONE of the following features: i. Superior mesenteric vein (SMV) or Portal vein (PV) with a tumor interface of ≥ 180° OR short segment occlusion of SMV or PV amenable to reconstruction ii. Superior mesenteric artery (SMA) or celiac axis (CA) with a tumor interface of \< 180° iii. Any degree of hepatic artery interface that is amenable to reconstruction b. Locally advanced pancreatic adenocarcinoma (LAPC) has at least ONE of the following features: i. Occlusion of the SMV or PV that is not amenable to reconstruction ii. Tumor interface of the superior mesenteric artery or celiac axis ≥ 180° iii. Involvement of the hepatic artery that is not amenable to reconstruction iv. Involvement of the aorta
• Has had a 4-month course (± 2-months) of chemotherapy for PDAC without radiographic evidence of distant metastatic disease. Following chemotherapy regimens are allowed:
• gemcitabine/nab-paclitaxel
• gemcitabine/capecitabine
• gemcitabine/cisplatin
• gemcitabine
• FOLFOX
• FOLFIRINOX
• Amenable to undergo the endoscopic ultrasound guided injection of NBTXR3 as per investigator or treating physician.
• Has a target lesion in the pancreas that is identifiable on cross sectional imaging by repeated measurements (via RECIST 1.1) at the same anatomical location

You may not qualify if:

• Prior radiation therapy to the upper abdomen
• Prior surgical resection of pancreatic tumor
• Diagnosis other than pancreatic ductal adenocarcinoma. All other histologic types (i.e., adenosquamous, cystadenocarcinoma, etc.) are not eligible to participate on this study.
• LAPC or BRPC with radiographic evidence of distant metastasis at screening.
• Known uncontrolled (Grade ≥ 2) or active gastric or duodenal ulcer disease within 30 days of enrollment
• Known contraindication to iodine-based or gadolinium-based IV contrast
• Active malignancy, in addition to pancreatic cancer, with the exception of basal cell carcinoma of the skin definitively treated and relapse free within at least 1 year from diagnosis
• Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second or third degree atrioventricular heart block without a permanent pacemaker in place)
• Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system \<6 months prior to screening
• Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection
• a. Patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible.
• Female patients who are pregnant or breastfeeding
• Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \< 1% per year when used consistently and correctly
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Eugene J Koay

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: July 24, 2020
• Study Start: July 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-10

Locations

US (1)