Gastric CancerEarly Phase 1NCT07707531
A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled IR199 in Patients With Gastric Cancer and Pancreatic Cancer
A Early Phase 1 study testing [68Ga]/ [131I]-IR199 in people with Gastric Cancer and Pancreatic Cancer, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Pancreatic Cancer
- What is being tested?
- [68Ga]/ [131I]-IR199
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai
Yihui Guan, MD, +86 13764308300, guanyihui@hotmail.com
Zhongguang Luo, MD
About this study
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
- Being tested
- [68Ga]/ [131I]-IR199
- Keywords
- gastric cancer, pancreatic cancer
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]/ [131I]-IR199Drug
[68Ga]/ [131I]-IR199, single dose
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]/ [131I]-IR199, single dose | Experimental | [68Ga]/ [131I]-IR199, single dose Receives: Drug: [68Ga]/ [131I]-IR199 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Incidence and severity of adverse events (AEs) as assessed by CTCAE v6.0
Measured: From administration of [68Ga]/ [131I]-IR199 until 1 week after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jun 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiHui Guan, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707531
- Sponsor's protocol ID
- KY2026-054
- Status last verified
- Mar 2026
- First submitted
- 29 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled IR199 in Patients With Gastric Cancer and Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07707531
- Acronym / sponsor ID
- KY2026-054
- Conditions
- Gastric Cancer, Pancreatic Cancer
- Keywords
- gastric cancer, pancreatic cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]/ [131I]-IR199, single dose | Experimental | Drug: [68Ga]/ [131I]-IR199[68Ga]/ [131I]-IR199, single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]/ [131I]-IR199[68Ga]/ [131I]-IR199, single dose | Drug | [68Ga]/ [131I]-IR199, single dose |
Primary outcome
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
1 secondary outcome
Safety Assessment
Time frame: From administration of [68Ga]/ [131I]-IR199 until 1 week after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [68Ga]/ [131I]-IR199 in people with Gastric Cancer and Pancreatic Cancer, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yihui Guan, MD (+86 13764308300, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.