Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

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Source: NCT06646783

Not yet recruiting

Phase IIT Trial of SNA014

Gastric CancerPancreatic Cancer

Phase 1

The First Affiliated Hospital of Soochow University

China

Sponsor: SmartNuclide Biopharma

Last Updated: October 17, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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

Study Type

Diagnostic

Radiation

Positron

Radiopharmaceutical

Ga-68 SNA014

Target

CLDN18.2

Trial Started

October 20, 2024

Last Updated by Sponsor

October 17, 2024

Estimated Completion

October 20, 2025

Eligibility

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;

Design Details

AllocationN/A

Intervention ModelSequential Assignment

MaskingNone (Open Label)

Number to Enroll28

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: subgroups mass does escalation

Interventions:

[68Ga]Ga-NODAGA-SNA014

Outcome Measures

Primary Outcome Measures

Biological distribution characteristics1week

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 characteristicshrough study completion, an average of 1 year

AE/SAE/SUSAR

Secondary Outcome Measures

Metabolic Dynamics Evaluation and Radiation Dose1 day

Detect the radiation dose of whole blood and serum of the subjects, and calculate the absorbed dose of important organs

Exploring the targeting ability of CLDN18.21month

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)

Trial Sites

This study has 1 trial site

The First Affiliated Hospital of Soochow University
Jiangsu, province, CN

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