A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled IR199 in Patients With Gastric Cancer and Pancreatic Cancer
Recruiting · NCT07707531 · Interventional (participants receive a specific treatment) · Lead sponsor: Huashan Hospital
View the official record on ClinicalTrials.gov →Interventions studied
[68Ga]/ [131I]-IR199
What this trial is about
This study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the \[68Ga\]/ \[131I\]-IR199 in patients with Claudin 18.2 positive gastric cancer and pancreatic cancer.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver.
- Age equal to or above 18 years old.
- Histologically or cytologically confirmed gastric cancer or pancreatic cancer with Claudin 18.2 expression.
- Must have ≥1 Claudin 18.2 positive lesions.
Exclusion criteria
- Less than two weeks since the last treatment that could cause bone marrow suppression.
- Known or suspected history of ≥3 grade renal and urinary system diseases.
- Medical history of allergy, hypersensitivity reaction or intolerance to radioactive drugs.
Where it is running
1 location listed.
- Huashan Hospital - Shanghai, China