Phase IIT Trial of SNA014

Early Phase 1

Not yet recruiting

• Conditions: Adenocarcinoma of the Stomach; Adenocarcinoma of GE Junction; Pancreatic Cancer Stage
• Interventions: Drug: [68Ga]Ga-NODAGA-SNA014

• Registration Number: NCT06646783
• Lead Sponsor: SmartNuclide Biopharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Study Start: 2024-10-20
• Primary Completion: 2025-10-20
• Study Completion: 2025-11-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
dose escalation	[68Ga]Ga-NODAGA-SNA014	subgroups mass does escalation

Primary Outcome Measures

Name	Time	Method
Biological distribution characteristics	1week	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).
Safety tolerance characteristics	hrough study completion, an average of 1 year	AE/SAE/SUSAR

Secondary Outcome Measures

Name	Time	Method
Metabolic Dynamics Evaluation and Radiation Dose	1 day	Detect the radiation dose of whole blood and serum of the subjects, and calculate the absorbed dose of important organs

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Jiangsu, province, China