A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled IR199 in Patients With Gastric Cancer and Pancreatic Cancer

Sponsor
Huashan Hospital
Study ID
NCT07707531
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [68Ga]/ [131I]-IR199 — DRUG
    \[68Ga\]/ \[131I\]-IR199, single dose

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: [68Ga]/ [131I]-IR199, single dose
    \[68Ga\]/ \[131I\]-IR199, single dose

Primary Outcome Measure

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 ]

Central Contacts

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