Solid Tumor, AdultNCT04989010
Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET Imaging in Patients With CLDN18.2 Positive Solid Tumors
A study testing 89Zr-NY005 in people with Solid Tumor, Adult, run by Wuxi No. 4 People's Hospital at 1 site in China.
Trial summary
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled anti-CLDN18.2 mAbs (89Zr-NY005) PET imaging in patients with CLDN18.2 positive solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- 89Zr-NY005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily signed informed consent, and be able to complete the trial according to the requirement of the scheme;
- Aged 18-80, male or female;
- The clinical diagnosis was gastric cancer, esophageal cancer and pancreatic cancer;
- Patients with biopsy-proven CLDN18.2 positive;
- Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
- At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
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- ECOG score ≤ 0~3; Life expectancy of at least 3 months;
- ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit.
- Other routine examinations are within the normal range or considered acceptable by the researchers.
Who cannot join
- Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
- Patients with systemic or locally severe infections, or other serious coexisting diseases;
- Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
- Patients with autoimmune diseases, including rheumatoid arthritis;
- Inadequate control of arrhythmias, including atrial fibrillation;
- Uncontrolled hypertension;
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- Patients with allergies or allergies to any component of the imaging agent or antibody;
- Patients who cannot undergo PET/CT imaging scan;
- Syphilis, HBV, HCV, or HIV positive subjects;
- Male and female subjects of reproductive age cannot take effective contraceptive measures;
- Pregnant or lactating women;
- Patients with a history of mental illness or related conditions;
- Other subjects considered unsuitable by researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Wuxi No. 4 People's Hospital
Wuxi, Jiangsu, 214062
Chunjing Yu, MD., 15312238622, ycj_wxd1978@163.com
About this study
Official title: Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET-CT Imaging in Patients With CLDN18.2 Positive Solid Tumors
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled anti-CLDN18.2 mAbs (89Zr-NY005) PET imaging in patients with CLDN18.2 positive solid tumors.
Read the detailed description
After being fully informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of anti-CLDN18.2 mAbs(89Zr-NY005) and will undergo PET/CT scanning to determine uptake of 89Zr-NY005 in tumor lesions and normal tissues and organs.
- Conditions
- Solid Tumor, Adult
- Being tested
- 89Zr-NY005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-NY005Drug
89Zr-NY005 injection followed by 89Zr-NY005 PET scan
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-NY005 injection | Experimental | Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3 mCi) labeled anti-CLDN18.2 mAbs (89Zr-NY005) Receives: Drug: 89Zr-NY005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of tissue distribution of 89Zr-Anti-CLDN18.2 mAbs(NY005)
Biodistribution of 89Zr-Anti-CLDN18.2 mAbs (NY005) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 89Zr-PET scans will be reported.
Measured: 1 year
Pharmacokinetic analysis of 89Zr-Anti-CLDN18.2 mAbs (NY005).
Area under the radioactivity (SUVs) versus time (time from injection) curve (AUC) will be derived by integration and reported.
Other pharmacokinetic parameters including peak radioactive uptake (Cmax) and time (Tmax) in different organs, clearance and volume of distribution, evaluated using a biexponential model and non-compartmental analysis, will be reported.
Measured: 1 year
Dosimetry estimates of 89Zr-Anti-CLDN18.2 mAbs (NY005).
Absorbed dose (radioactive uptake) estimates for different organs and tissues calculated with the AUCs and the OLINDA/EXM dosimetry program will be obtained and reported.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi No. 4 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989010
- Sponsor's protocol ID
- LS-CLDN18.2 001
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET-CT Imaging in Patients With CLDN18.2 Positive Solid Tumors
- ClinicalTrials.gov ID
- NCT04989010
- Acronym / sponsor ID
- LS-CLDN18.2 001
- Conditions
- Solid Tumor, Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wuxi No. 4 People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 4 Aug 2021 (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 is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled anti-CLDN18.2 mAbs (89Zr-NY005) PET imaging in patients with CLDN18.2 positive solid tumors.
Detailed description
After being fully informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of anti-CLDN18.2 mAbs(89Zr-NY005) and will undergo PET/CT scanning to determine uptake of 89Zr-NY005 in tumor lesions and normal tissues and organs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-NY005 injection | Experimental | Drug: 89Zr-NY005Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3 mCi) labeled anti-CLDN18.2 mAbs (89Zr-NY005) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients voluntarily signed informed consent, and be able to complete the trial according to the requirement of the scheme;
- Aged 18-80, male or female;
- The clinical diagnosis was gastric cancer, esophageal cancer and pancreatic cancer;
- Patients with biopsy-proven CLDN18.2 positive;
- Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
Key exclusion criteria (13 listed)
- Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
- Patients with systemic or locally severe infections, or other serious coexisting diseases;
- Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
- Patients with autoimmune diseases, including rheumatoid arthritis;
- Inadequate control of arrhythmias, including atrial fibrillation;
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 |
|---|---|---|
| 89Zr-NY00589Zr-NY005 injection followed by 89Zr-NY005 PET scan | Drug | 89Zr-NY005 injection |
Primary outcome
Evaluation of tissue distribution of 89Zr-Anti-CLDN18.2 mAbs(NY005)
Time frame: 1 year
Biodistribution of 89Zr-Anti-CLDN18.2 mAbs (NY005) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 89Zr-PET scans will be reported.
Pharmacokinetic analysis of 89Zr-Anti-CLDN18.2 mAbs (NY005).
Time frame: 1 year
Area under the radioactivity (SUVs) versus time (time from injection) curve (AUC) will be derived by integration and reported. Other pharmacokinetic parameters including peak radioactive uptake (Cmax) and time (Tmax) in different organs, clearance and volume of distribution, evaluated using a biexponential model and non-compartmental analysis, will be reported.
Dosimetry estimates of 89Zr-Anti-CLDN18.2 mAbs (NY005).
Time frame: 1 year
Absorbed dose (radioactive uptake) estimates for different organs and tissues calculated with the AUCs and the OLINDA/EXM dosimetry program will be obtained and reported.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 89Zr-NY005 in people with Solid Tumor, Adult, run by Wuxi No. 4 People's 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 9 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 4 Aug 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of tissue distribution of 89Zr-Anti-CLDN18.2 mAbs(NY005) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 4 Aug 2021.