Recruiting NCT07707531
A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled IR199 in Patients With Gastric Cancer and Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [68Ga]/ [131I]-IR199.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Pancreatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug [68Ga]/ [131I]-IR199
\[68Ga\]/ \[131I\]-IR199, single dose
Primary outcome measures
- Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry [Time frame: about 24 hours from time of injection, about 48 hours from time of injection and about 72 hours from time of injection]
Secondary outcome measures (1)
- Safety Assessment [Time frame: From administration of [68Ga]/ [131I]-IR199 until 1 week after injection]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Huashan Hospital — Shanghai
Identifiers
NCT: NCT07707531 · KY2026-054