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NCT Number: NCT07707531

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

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.

Recruiting

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Huashan Hospital

Shanghai, China

Location status: Recruiting

Location contact

Yihui Guan, MD

CONTACT

[email protected]

+86 13764308300

Zhongguang Luo, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[68Ga]/ [131I]-IR199

Drug

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

Primary outcomes

  1. 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

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

Secondary outcomes

  1. Safety Assessment

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

    Incidence and severity of adverse events (AEs) as assessed by CTCAE v6.0

Study contacts

Contact information is provided by the study sponsor or research team.

Yihui Guan, MD

CONTACT

[email protected]

+86 13764308300

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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