Clinical trial · Interventional
A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled IR199 in Patients With Gastric Cancer and Pancreatic Cancer
NCT07707531CI-TRIAL-00118151recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]/ [131I]-IR199 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]/ [131I]-IR199, single dose
- description
- \[68Ga\]/ \[131I\]-IR199, single dose
- interventionNames
- Drug: [68Ga]/ [131I]-IR199
Primary outcomes (1)
- measure
- Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry
- timeFrame
- about 24 hours from time of injection, about 48 hours from time of injection and about 72 hours from time of injection
- description
- Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry
Secondary outcomes (1)
- measure
- Safety Assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver. 2. Age equal to or above 18 years old. 3. Histologically or cytologically confirmed gastric cancer or pancreatic cancer with Claudin 18.2 expression. 4. Must have ≥1 Claudin 18.2 positive lesions. Exclusion Criteria: 1. Less than two weeks since the last treatment that could cause bone marrow suppression. 2. Known or suspected history of ≥3 grade renal and urinary system diseases. 3. Medical history of allergy, hypersensitivity reaction or intolerance to radioactive drugs.
References
Publications (0)
Data not yet available
No reference posted for this study.