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Phase IIT Trial of SNA014

S

SmartNuclide Biopharma

Status and phase

Not yet enrolling
Early Phase 1

Conditions

Adenocarcinoma of the Stomach
Adenocarcinoma of GE Junction
Pancreatic Cancer Stage

Treatments

Drug: [68Ga]Ga-NODAGA-SNA014

Study type

Interventional

Funder types

Industry

Identifiers

NCT06646783
[68Ga]Ga-NODAGA-SNA014

Details and patient eligibility

About

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

Enrollment

28 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

28 participants in 1 patient group

dose escalation
Experimental group
Description:
subgroups mass does escalation
Treatment:
Drug: [68Ga]Ga-NODAGA-SNA014

Trial contacts and locations

1

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Central trial contact

Miao liyan Chief Pharmacist, doctorate

Data sourced from clinicaltrials.gov

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