Phase IIT Trial of SNA014

ConditionsAdenocarcinoma of the Stomach Adenocarcinoma of GE Junction Pancreatic Cancer Stage

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorSmartNuclide Biopharma

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

[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.

Treatment groups

28 Participants

are divided into 1 treatment group

Group A: dose escalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

1week

Safety tolerance characteristics

AE/SAE/SUSAR

Time frame

hrough study completion, an average of 1 year

Secondary outcomes

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

Time frame

1 day

Other outcomes

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)

Time frame

1month

Locations

Map coordinates are unavailable for these locations. Locations are shown below instead.

The First Affiliated Hospital of Soochow University Status unavailable 215000, Jiangsu, Province China

China

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SmartNuclide Biopharma

Lead sponsor

Source ClinicalTrials.gov

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