Borderline Resectable Pancreatic AdenocarcinomaPhase 1NCT04484909
NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resectable Pancreatic Cancer
A Phase 1 study testing Hafnium Oxide-containing Nanoparticles NBTXR3 and Radiation Therapy in people with Borderline Resectable Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Ductal Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Hafnium Oxide-containing Nanoparticles NBTXR3 and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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:
- 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:
- 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
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- 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
- Nodal disease only is not allowed.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Laboratory Values at screening:
- Hemoglobin ≥ 8.0 g/dL
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
- Platelet Count ≥ 100,000/mm3
- Creatinine ≤ 1.5 x upper limit of normal (ULN)
- Total Bilirubin ≤ 2.0 mg/dL
- AST / ALT ≤ 3.0 x upper limit of normal (ULN)
- Serum albumin ≥ 3.0 g/dL
- Negative pregnancy test ≤ 7 days prior to NBTXR3 injection in all females of child-bearing potential
- If participant has a history of prior duodenal or biliar plastic stent, it should be replaced with a metal stent ≥ 1 week prior to Study Day 1.
Who cannot join
- 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.
- Has received any approved or investigational anti-neoplastic agent other than the chemotherapies specified in this protocol (i.e. chemotherapies included in Inclusion #4)
- Known uncontrolled (Grade ≥ 2) or active gastric or duodenal ulcer disease within 30 days of enrollment
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- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of NBTXR3 Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Ductal Adenocarcinoma
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.
Read the 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
- Being tested
- Hafnium Oxide-containing Nanoparticles NBTXR3, Radiation Therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hafnium Oxide-containing Nanoparticles NBTXR3Other
Also called NBTXR3
Given IT
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation
Undergo radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hafnium Oxide-containing Nanoparticles NBTXR3; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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%.
Measured: Up to 1 year
Recommended phase II dose (RP2D)
Measured: Up to 1 year
Secondary outcomes (3)
Determination of the feasibility of NBTXR3 injection in pancreas
Feasibility refers to the ability to do intratumoral injection of NBTXR3. The outcome for each patient would be "feasible" or "not feasible."
Measured: Up to 1 year
Progression free survival (PFS)
Measured: 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)
Measured: From NBTXR3 injection to death from any cause or EoS, whichever occurs first, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Resectable Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eugene J Koay, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484909
- Sponsor's protocol ID
- 2019-1001
- Other IDs
- NCI-2020-03731, 2019-1001
- Status last verified
- Oct 2025
- First submitted
- 10 Jun 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No