Phase IIT Trial of SNA014

NCT06646783 | Not Yet Recruiting Early Phase 1

• 1 other identifier: [68Ga]Ga-NODAGA-SNA014
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adenocarcinoma of the Stomach; Adenocarcinoma of GE Junction; Pancreatic Cancer Stage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Metabolic Dynamics Evaluation and Radiation Dose

  1 day

Other Outcomes (1)

• Exploring the targeting ability of CLDN18.2

  1month

Study Arms (1)

dose escalation

EXPERIMENTAL

subgroups mass does escalation

Drug: [68Ga]Ga-NODAGA-SNA014

Interventions

[68Ga]Ga-NODAGA-SNA014 DRUG

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.

dose escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• SmartNuclide Biopharma: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Jiangsu, Province, 215000, China

Location

Central Study Contacts

Miao liyan Chief Pharmacist, doctorate

CONTACT

0512-679-72858; miaolysuzhou@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 17, 2024
• Study Start: October 20, 2024
• Primary Completion: October 20, 2025
• Study Completion: November 20, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)