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Trial Title:
Phase IIT Trial of SNA014
NCT ID:
NCT06646783
Condition:
Adenocarcinoma of the Stomach
Adenocarcinoma of GE Junction
Pancreatic Cancer Stage
Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga]Ga-NODAGA-SNA014
Description:
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.
Arm group label:
dose escalation
Summary:
68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for gastric or
gastroesophageal junction
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Jiangsu
Zip:
215000
Country:
China
Contact:
Last name:
ZhangHua Chief Pharmacist, doctorate
Phone:
0512-677-80040
Email:
Sdfyy8040@126.com
Start date:
October 20, 2024
Completion date:
November 20, 2025
Lead sponsor:
Agency:
SmartNuclide Biopharma
Agency class:
Industry
Source:
SmartNuclide Biopharma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06646783
