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 range18 Years – 85 Years
SexALL
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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).
✓. 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.
What they're measuring
1
Adverse events (AE) and severe adverse events (SAE)
Timeframe: Through study completion, an average of 18 months
✕. 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.