Gastric and pancreatic cancer patients see if IR199 with Ga-68 and I-131 is safe and how it distributes in the body
Official title: A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled IR199 in Patients With Gastric Cancer and Pancreatic Cancer
Run by Huashan Hospital · NCT07707531 · Data updated 2026-11-12
This study tests the safety and how the radio-labeled IR199 distributes in the body of adults with Claudin 18.2-positive gastric or pancreatic cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Huashan Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT07707531 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with histologically or cytologically confirmed Claudin 18.2-positive gastric or pancreatic cancer and at least one Claudin 18.2-positive lesion.
✕Probably not a fit
Patients without Claudin 18.2 expression or those not meeting other safety criteria may not benefit from this imaging and dosimetry study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early phase 1 study investigates the biodistribution, radiation dose, and tumor uptake of 68Ga/131I-IR199 in patients with Claudin 18.2-positive gastric or pancreatic cancer. Participants receive the radiolabeled agent and undergo imaging and safety assessments to characterize where the compound goes in the body and how much radiation is delivered. The goal is to determine safety and dosimetry to guide future trials. Eligible patients must have Claudin 18.2 expression and at least one positive lesion, and must meet standard safety criteria. The study is sponsored by Huashan Hospital in Shanghai.
Why it matters
Potential benefit: If successful, participants may contribute to the development of targeted radiopharmaceuticals for gastric and pancreatic cancers, potentially informing future therapies.
How similar studies have gone: Other early-phase radiopharmaceutical biodistribution studies have established safety and imaging feasibility for similar approaches, supporting further development.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Huashan Hospital
Shanghai, China Recruiting
Study contacts
- Study coordinator: Yihui Guan, MD
- Email: guanyihui@hotmail.com
- Phone: +86 13764308300
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.