Evaluating NRT6008 for patients with advanced pancreatic cancer

A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of NRT6008 Injection in Unresectable Locally Advanced Pancreatic Cancer (LAPC)

This study is testing a new injection called NRT6008 to see if it is safe and effective for people with advanced pancreatic cancer that can't be removed by surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Chengdu New Radiomedicine Technology Co. LTD. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 6 sites (Zhengzhou, Henan and 5 other locations)
• Trial ID: NCT06278454 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, multi-center phase I trial assessing the safety and efficacy of NRT6008 injection in patients with unresectable locally advanced pancreatic cancer (LAPC). The study includes a dose escalation phase and a dose expansion phase, with a safety review committee monitoring the data throughout. The primary focus is on evaluating the safety of the injection, while secondary objectives include assessing preliminary efficacy, distribution of the injection in the body, changes in tumor biomarkers, and improvement in cancer pain status.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with histologically confirmed unresectable LAPC and a single measurable pancreatic lesion.

Not a fit: Patients with resectable pancreatic cancer or those with multiple lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with unresectable pancreatic cancer.

How similar studies have performed: While the specific use of NRT6008 is novel, similar approaches using targeted therapies in pancreatic cancer have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Aged ≥18 years and ≤80 years, able to comprehend and sign an informed consent form;
2. Diagnosed with pancreatic adenocarcinoma confirmed histologically or cytologically;
3. Evaluated as unresectable LAPC by the investigator, or having contraindications to surgery, or refusing surgical resection (only patients with non-regional lymph node metastasis are eligible);
4. ECOG performance status score ≤1;
5. Expected survival ≥3 months;
6. According to RECIST v1.1 criteria, there is only one measurable lesion in the pancreas confirmed by imaging, and the lesion has the shortest axis diameter ≥2.0 cm, the longest axis diameter ≤6.0 cm (based on baseline imaging);
7. Adequate normal organ and marrow function as defined below: (1) Renal function: serum creatinine ≤1.5×ULN, or creatinine clearance ≥60 mL/min (calculated by the Cockcroft-Gault formula); (2) Liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN; serum total bilirubin ≤1.5×ULN; (3) Bone marrow function \[\[no blood transfusion or granulocyte colony-stimulating factor (G-CSF), human thrombopoietin (TPO), or TPO receptor agonist treatment within 14 days prior to signing informed consent\]: neutrophils ≥1.5×10\^9/L, hemoglobin ≥90 g/L, platelets ≥100×10\^9/L; (4) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
8. Female and male participants of reproductive age must voluntarily agree to practice strict and effective contraception after signing the informed consent form, during the study period, and within 12 months after administration of the investigational drug. Males are prohibited from donating sperm during this period. Female participants of reproductive age must have a negative pregnancy test result during the screening period and within 24 hours before administration of the investigational drug.

Exclusion Criteria:

1. Allergic to the investigational drug NRT6008 injection itself or any of its components;
2. Contraindications to any of the three optional systemic chemotherapy regimens in this study judged by investigators;
3. Previous anti-tumor treatments for pancreatic cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. Except for discontinuation of traditional chinese medicine or herbal medicine for at least 7 days prior to the screening period;
4. Contraindications to anesthesia;
5. History of any other malignant tumors within 5 years before receiving investigational drug treatment, except for cases of cured non-melanoma skin cancer, cervical carcinoma in situ, or basal cell carcinoma of the skin, Stage I Grade 1 endometrial carcinoma, or thyroid cancer;
6. Presence or suspected presence of distant metastases according to imaging;
7. Pregnant or lactating females;
8. Participants assessed by the investigators to be at high risk or had difficulty in operation for EUS-FNI procedures;
9. Evidence of radiographic invasion into stomach, duodenum or peritoneum;
10. Participants with chronic diseases that are actively treated but not well controlled, such as primary hypertension, diabetes, etc.;
11. Within 6 months prior to the the first administration of chemotherapy, occurrence of acute pancreatitis, severe gastrointestinal bleeding, severe cardiovascular diseases (including but not limited to stroke, unstable angina), or occurrence of acute infections requiring systemic treatment within 2 weeks before the screening period;
12. Participated in other interventional clinical trials within 1 month prior to the first administration of chemotherapy;
13. Positive for human immunodeficiency virus (HIV) antibodies;
14. Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), HBV DNA testing required, participants with HBV-DNA levels below the lower limit of the reference range or \< 500 IU/mL will be eligible for inclusion in this study (use of antiviral drugs during the study period is required);
15. Positive for hepatitis C virus (HCV) antibodies, HCV RNA testing required, participants with negative HCV RNA results will be eligible for inclusion in this study;
16. Participants with syphilis infection or active tuberculosis;
17. Other reasons deemed unsuitable for participation in this trial by the investigators.

Where this trial is running

Zhengzhou, Henan and 5 other locations

• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• Shanghai Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Chongqing University Cancer Hospital — Chongqing, China (Recruiting)
• Tianjin Medical University General Hospital — Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Zhaoshen Li — Changhai Hospital
• Study coordinator: Zhaoshen Li, MD

Conditions Unresectable Pancreatic Cancer; Yttrium-90; Endoscopic ultrasound-guided fine-needle injection; Locally Advanced Pancreatic Carcinoma