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

NCT07707531 | Recruiting Early Phase 1 DMC

• 1 other identifier: KY2026-054
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer; Pancreatic Cancer

Keywords

gastric cancer; pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry

  Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry

  about 24 hours from time of injection, about 48 hours from time of injection and about 72 hours from time of injection

Secondary Outcomes (1)

• Safety Assessment

  From administration of [68Ga]/ [131I]-IR199 until 1 week after injection

Study Arms (1)

[68Ga]/ [131I]-IR199, single dose

EXPERIMENTAL

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

Drug: [68Ga]/ [131I]-IR199

Interventions

[68Ga]/ [131I]-IR199 DRUG

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

[68Ga]/ [131I]-IR199, single dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Yihui Guan, MD

CONTACT

+86 13764308300; guanyihui@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-03

Locations

CN (1)