Phase IIT Trial of SNA014

Clinical Study of 68GA-labeled Claudin 18.2 Developer Combined with PET/CT for Imaging of Gastric or Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer

68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for gastric or gastroesophageal junction

Study Overview

• Status: Not yet recruiting
• Conditions: Adenocarcinoma of GE Junction; Adenocarcinoma of the Stomach; Pancreatic Cancer Stage
• Intervention / Treatment: Drug: [68Ga]Ga-NODAGA-SNA014

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Miao liyan Chief Pharmacist, doctorate; Phone Number: 0512-679-72858; Email: miaolysuzhou@163.com

Study Locations

• China
  • province
    • Jiangsu, province, China, 215000
      • The First Affiliated Hospital of Soochow University
      • Contact: ZhangHua Chief Pharmacist, doctorate; Phone Number: 0512-677-80040; Email: Sdfyy8040@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age range of 18 to 75 years old (including boundary values);
• Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);
• Diagnosed G/GEJ adenocarcinoma and pancreatic cancer;
• Gastroscopy/CT/MRI/PET-CT examination results within the past month (if any);
• Pathological test results and Claudin18.2 immunohistochemistry results within the past year (if available).

Exclusion Criteria:

• Merge patients with other clearly diagnosed malignant tumors:
• Uncontrolled severe infections or individuals with other serious illnesses;
• Those with an expected survival period of less than or equal to three months;
• Pregnant or lactating patients, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial;
• investigators determine that patients who are not suitable to participate in this study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: dose escalation; subgroups mass does escalation

Drug: [68Ga]Ga-NODAGA-SNA014; Perform whole-body PET/CT scans on the subjects at 30 minutes (± 5 minutes), 60 minutes (± 10 minutes), 120 minutes (± 20 minutes), and 240 minutes (± 30 minutes) after administration. Among them, PET scanning can be performed on 1-2 subjects in a certain dose group or each dose group for 30-60 minutes. Among the four CT scans, one CT scan is a conventional low-dose CT scan (120mA), and the remaining three are extremely low-dose CT scans (10-20mA). The main researchers and nuclear medicine physicians can decide whether to change the subsequent image acquisition time and duration of the subjects based on the image information obtained from the enrolled subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological distribution characteristics	Evaluate the biological distribution characteristics of important organs in the subjects.; Draw the Volume of Interest (VOI) of the subject's vital organs and calculate the Percentage of Injected Activity (IA) of the vital organs; Using PMOD software, manually draw regions of interest (VOI) on PET/CT images of the liver, spleen, normal stomach, heart, bone marrow, kidneys, and other areas to obtain the cumulative radioactive activity of these regions. Divide the cumulative radioactive activity by the injection dose to obtain the percentage of injection activity (% IA).	1week
Safety tolerance characteristics	AE/SAE/SUSAR	hrough study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic Dynamics Evaluation and Radiation Dose	Detect the radiation dose of whole blood and serum of the subjects, and calculate the absorbed dose of important organs	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploring the targeting ability of CLDN18.2	Correlation analysis between PET/CT imaging features of target lesions (SUVmax, SUV mean, target to body ratio, etc.) and CLDN18.2IHC expression level (if any)	1month

Collaborators and Investigators

• Sponsor: SmartNuclide Biopharma

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2024
• Primary Completion (Estimated): October 20, 2025
• Study Completion (Estimated): November 20, 2025

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Adenocarcinoma; Pancreatic Neoplasms
• Other Study ID Numbers: [68Ga]Ga-NODAGA-SNA014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No