Safety and Efficacy of NRT6008 Administered in Combination With Chemotherapy in Patients With Unr… (NCT07555587) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Efficacy of NRT6008 Administered in Combination With Chemotherapy in Patients With Unresectable Locally Advanced Pancreatic Carcinoma (LAPC)
Australia10 participantsStarted 2026-09
Plain-language summary
This is a phase Ib, open-label study to evaluate safety and efficacy of NRT6008 in combination with standard-of-care chemotherapy in patients with unresectable Locally Advanced Pancreatic Carcinoma (LAPC).
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged ≥18 and ≤85 years of age and able to understand and sign the informed consent form (ICF).
. Histopathological or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas.
. Deemed by the Investigator to have unresectable locally advanced pancreatic cancer.
. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
. Life expectancy of at least 3 months in the opinion of the Investigator.
. Must have only one measurable target radiologically confirmed lesion in the pancreas according to RECIST 1.1, with the longest diameter of ≤ 6 cm and the shortest diameter of ≥ 2 cm (based on baseline imaging).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events (AE) and severe adverse events (SAE)
Timeframe: Through study completion, an average of 18 months
. Adequate organ and marrow function as defined by the following criteria:
. Renal function: Blood creatinine ≤ 1.5 × the upper limit of normal (ULN), or eGFR ≥ 60 mL/min \[by a clinically validated calculator such as Modification of diet in renal disease (MDRD) formula\];
Exclusion criteria
. Allergic to the investigational device NRT6008 Injection or any of its components.
. Participants who are deemed by the Investigator to be clinically inappropriate for treatment with either standard-of-care chemotherapy regimen (Regimen group A or Regimen group B).
. Prior anti-tumour therapy for pancreatic carcinoma, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
. Contraindications to anaesthesia.
. Participants who have any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or nonmelanoma skin cancer in the past 5 years. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the study Sponsor, if it is determined not to put the participant at an increased risk of adverse device effects and/or interfere with the integrity of study outcome.
. Presence or suspicion of distant metastasis, including non-regional lymph nodes, on imaging.
. Pregnant or lactating women.
. The participant is considered by the Investigator to be at an unacceptably high risk for the EUS-FNI procedure, or the procedure is deemed technically infeasible based on clinical judgment.