Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC)

NCT06278454 | Recruiting Phase 1

• 2 other identifiers: NrtPac-1CTR20240312
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 6

Brief Summary

This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study.

Conditions

Unresectable Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D)

  Optimal dose for NRT6008 injection

  28 days after NRT6008 administration

• Dose-limiting toxicity (DLT)

  Incidence rate of DLT

  28 days after NRT6008 administration

• Adverse events (AE) and severe adverse events (SAE)

  Incidence rate and severity of AE and SAE

  Up to 52 weeks

Secondary Outcomes (5)

• Objective response rate (ORR)

  Up to 52 weeks

• Duration of response (DOR)

  Up to 52 weeks

• Progression-free survival (PFS)

  Up to 52 weeks

• Overall survival (OS)

  Up to 52 weeks

• Resection rate (R0 and R1)

  Up to 52 weeks

Other Outcomes (3)

• Concentration of tumor biomarkers

  Up to 52 weeks

• Numeric rating scale (NRS) of pain

  Up to 52 weeks

• Distribution of NRT6008 injection in human body and radioactivity of biological samples

  Up to 48 hours

Study Arms (1)

NRT6008 Injection

EXPERIMENTAL

In this study, participants shall receive NRT6008 injection in combination with chemotherapy.

Drug: NRT6008 Injection + Systematic chemotherapy

Interventions

NRT6008 Injection + Systematic chemotherapy DRUG

-Systematic chemotherapy The chemotherapy regimen is selected by the investigators at the consideration of participants' conditions, with either GN or (m)FOLFIRINOX. GN: gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2, every 21 days (3 weeks/cycle). FOLFIRINOX: oxaliplatin 85 mg/m\^2, irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2 and fluorouracil 400 mg/m\^2 given as a bolus followed by 2400 mg/m\^2 given as a 46-hour continuous infusion, every 2 weeks (4 weeks/cycle). mFOLFIRINOX: oxaliplatin 85 mg/m\^2, irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2, and fluorouracil 2400 mg/m\^2 given as a 46-hour continuous infusion, every 2 weeks (4 weeks/cycle). -NRT6008 injection administration: NRT6008 injection is implanted into pancreatic tumor via endoscopic ultrasound (EUS)-guided fine-needle injection, at the instruction of the investigator. The dose of NRT6008 injection is determined by tumor volume and selected tumor average absorbed dose.

Also known as: Investigational Product + Systematic chemotherapy

NRT6008 Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years and ≤80 years, able to comprehend and sign an informed consent form;
• Diagnosed with pancreatic adenocarcinoma confirmed histologically or cytologically;
• 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);
• ECOG performance status score ≤1;
• Expected survival ≥3 months;
• 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);
• 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;
• 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.

You may not qualify if:

• Allergic to the investigational drug NRT6008 injection itself or any of its components;
• Contraindications to any of the three optional systemic chemotherapy regimens in this study judged by investigators;
• 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;
• Contraindications to anesthesia;
• 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;
• Presence or suspected presence of distant metastases according to imaging;
• Pregnant or lactating females;
• Participants assessed by the investigators to be at high risk or had difficulty in operation for EUS-FNI procedures;
• Evidence of radiographic invasion into stomach, duodenum or peritoneum;
• Participants with chronic diseases that are actively treated but not well controlled, such as primary hypertension, diabetes, etc.;
• 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;
• Participated in other interventional clinical trials within 1 month prior to the first administration of chemotherapy;
• Positive for human immunodeficiency virus (HIV) antibodies;
• Participants with syphilis infection or active tuberculosis;
• Other reasons deemed unsuitable for participation in this trial by the investigators.

Sponsors & Collaborators

• Chengdu New Radiomedicine Technology Co. LTD.: lead

Study Sites (6)

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 Officials

• Zhaoshen Li

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoshen Li, MD

CONTACT

+8602131162338; zhsl@vip.163.com

Study Design

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

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: January 9, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)