Breast CancerEarly Phase 1NCT07023861

The Exploration of Novel Radionuclide-labeled HER2-targeting Antibodies in the Diagnosis of HER2-positive Malignancies

A Early Phase 1 study testing 18F-FDG, 89Zr-LNCab190 and 89Zr-LNCab002 in people with Breast Cancer and Gastric Cancer (GC), run by Affiliated Hospital of Jiangnan University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

The purpose of this study is to develop and clinically evaluate 89Zr-labeled HER2-targeted antibodies in diagnosis and screening of HER2-positive cancer patients. Read more about this study

Who is it for?: Ages 15 to 75 years
Conditions the study is for: Breast Cancer, Gastric Cancer (GC), Urothelial Carcinoma (UC)
What is being tested?: 18F-FDG, 89Zr-LNCab190 and 89Zr-LNCab002
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 Jul 2025to 1 Dec 2026
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 15 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subjects voluntarily signed the informed consent form and was able to complete the trial according to the protocol requirements ;
18-75 years old, male or female ;
Clinical diagnosed with gastric cancer, breast cancer, urothelial carcinoma, diagnostic criteria refer to biopsy, and HER2 immunohistochemistry result is positive ;
Presence of at least one measurable lesion in the subject's body, which can be accurately and continuously measured by the modified RECIST criteria (version 1.1) ;
ECOG score of 0-3 ;
Complete blood count, coagulation function and liver and kidney function meet the following criteria (no blood transfusion, no use of hematopoietic stimulating factor drugs and no use of liver protection drugs within 14 days before administration): a) Blood routine: white blood cell count (WBC) ≥ 2.5×109/L or neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥ 100×109/L, hemoglobin ≥ 90 g/L; b) Coagulation function: prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5×ULN (limited to patients who are not receiving anticoagulant therapy; Patients receiving anticoagulant therapy should be on a stable dose of anticoagulant); c) Liver function: total bilirubin ≤ 1.5× ULN, ALT/AST ≤ 2.5× ULN, ALP ≤ 2.5×ULN; d) Renal function: urea (UREA) ≤ 1.5×ULN, serum creatinine ≤ 1.5× ULN, creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula) ;
Female subjects of childbearing potential must have a negative pregnancy test ;
Female subjects of childbearing potential as well as male subjects of childbearing potential must agree to use effective contraception or restrict sexual behavior for the duration of the study ;

Who cannot join

Those who are not suitable for PET/CT examination or cannot complete PET/CT examination for special reasons, including but not limited to claustrophobia, radiophobia, etc ;
Those who cannot tolerate intravenous administration (such as history of needle sickness and blood sickness) ;
Known allergy to chimeric or human antibodies or fusion proteins, or other excipients
Presence of any of the following: a) brain metastases (except for primary or metastatic brain tumors that are asymptomatic and do not require treatment); b) carcinomatous meningitis; c) diabetes mellitus with poor glycemic control; d) Myocardial infarction within 6 months prior to screening; e) unstable angina; f) Have a previous uncontrollable cardiac arrhythmia or are currently at high risk; g) Prior coronary artery bypass grafting; h) Cerebrovascular accident within 6 months prior to screening; i) congestive heart failure (cardiac function class III-IV); j) pulmonary embolism; k) deep vein thrombosis) concomitant infection requiring intravenous antibiotic treatment within 2 weeks prior to screening; m) History of immunosuppressant therapy after organ transplantation ;
Those who have had or are currently concomitant with primary central nervous system tumors ;
Those with a history of acute or subacute intestinal obstruction, or inflammatory bowel disease ;

Show all 13Show fewer

Toxicity from prior anticancer therapy has not recovered to grade 0 or 1 (CTCAE version 5.0), with the exception of alopecia ;
Presence of active autoimmune disease, or history of autoimmune disease requiring treatment with systemic hormones and/or immunosuppressants, or syndrome requiring systemic steroids or immunosuppressive medications;
Received or planned to receive immune checkpoint blockade therapy, including anti-CTLA-4, anti-PD-1 or anti-PD-L1 therapeutic antibodies, within 1 year prior to screening, prior to completion of the study imaging procedure, etc ;
Any psychiatric illness (e.g., alcohol or drug abuse, dementia, or altered mental status), or any other condition that affects study compliance, impairs the patient's ability to understand informed consent, or in the opinion of the investigator, would cause the patient to be unable to participate in the study or interfere with the interpretation of the study results ;
Those who have participated in clinical trials of radiopharmaceuticals within 1 month prior to screening ;
Drugs/clinical operators who have been evaluated by the investigator within 1 month prior to screening to affect the uptake of 89Zr-LNCab002, 89Zr-LNCab190 and 89Zr-LNCab072;
Patients who did not meet the requirements as assessed by the investigator.

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

Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000

Other trials in China

About this study

The purpose of this study is to develop and clinically evaluate 89Zr-labeled HER2-targeted antibodies in diagnosis and screening of HER2-positive cancer patients.

Read the detailed description

Main objectives:

Application of novel radionuclide-labeled HER2-targeting antibodies (89Zr-LNCab002, 89Zr-LNCab072, 89Zr-LNCab190) in the early diagnosis of breast cancer, gastric cancer, urothelial carcinoma and other diseases;
To evaluate the efficacy, safety and dosimetry of 89Zr-LNCab002, 89Zr-LNCab072, 89Zr-LNCab190 in clinical PET imaging applications.

Secondary Objectives:

To investigate the biodistribution of 89Zr-LNCab002, 89Zr-LNCab072 and 89Zr-LNCab190 in patients with breast cancer, gastric cancer and urothelial carcinoma, including the distribution of primary and metastatic tumors and normal tissues, through the evaluation of whole-body imaging and SUV values using PET/CT imaging.
Compared with 18F-FDG, the clinical application value and diagnostic advantages of the novel radionuclide-labeled HER2-targeting antibodies 89Zr-LNCab002, 89Zr-LNCab072 and 89Zr-LNCab190 were evaluated.

Conditions: Breast Cancer, Gastric Cancer (GC), Urothelial Carcinoma (UC)
Being tested: 18F-FDG, 89Zr-LNCab190, 89Zr-LNCab002, 89Zr-LNCab072
Keywords: breast cancer, Gastric Cancer (GC), Urothelial carcinoma (UC), HER2, PET/CT, 89Zr
Medical subject headings: Breast Neoplasms, Stomach Neoplasms, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

18F-FDGDrug
18F-FDG is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15 mCi/kg.
89Zr-LNCab190Drug
89Zr-LNCab190 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi
89Zr-LNCab002Drug
89Zr-LNCab002 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi
89Zr-LNCab072Drug
89Zr-LNCab072 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi

Study groups in NCT07023861
Study group	Role	What they receive
89Zr-LNCab190	Experimental	89Zr-LNCab190 injection (1-3 mCi) was injected intravenously for 45-60s. Receives: Drug: 18F-FDG; Drug: 89Zr-LNCab190
89Zr-LNCab002	Experimental	89Zr-LNCab002 injection (1-3 mCi) was injected intravenously for 45-60s. Receives: Drug: 18F-FDG; Drug: 89Zr-LNCab002
89Zr-LNCab072	Experimental	89Zr-LNCab072 injection (1-3mCi) was injected intravenously for 45-60s. Receives: Drug: 18F-FDG; Drug: 89Zr-LNCab072
18F-FDG	Active comparator	The corresponding patients underwent HER2 PET/CT examination within one week before and after routine 18F-FDG PET/CT imaging (control examination). PET/CT whole body scan was performed 45 min-1 h after intravenous injection of the developer, and the image processing was as usual. Receives: Drug: 89Zr-LNCab190; Drug: 89Zr-LNCab002; Drug: 89Zr-LNCab072

What is being measured

The primary outcome is the main question the study is designed to answer.

Tumor Uptake Value (SUVmax) of HER2-Targeted PET/CT Compared with 18F-FDG PET/CT
The maximum standardized uptake value (SUVmax) of identified lesions on HER2-targeted PET/CT using 89Zr-LNCab190, 89Zr-LNCab002, and 89Zr-LNCab072 will be measured and compared with the SUVmax of lesions detected on 18F-FDG PET/CT imaging in the same patients.
Units of Measure: SUVmax (unitless)
Measured: Day 1 post-injection
Number of Lesions Detected by HER2-Targeted PET/CT Compared with 18F-FDG PET/CT
The number of lesions detected by HER2-targeted PET/CT using 89Zr-labeled antibodies will be recorded and compared to the number of lesions detected by 18F-FDG PET/CT imaging in the same patient population.
Units of Measure: Number of lesions
Measured: Day 1 post-injection

Secondary outcomes (1)

Biodistribution of 89Zr-Labeled HER2-Targeted Antibodies in Normal Organs
The biodistribution of 89Zr-LNCab190, 89Zr-LNCab002, and 89Zr-LNCab072 will be evaluated by measuring the mean standardized uptake values (SUVmean) in various normal organs (e.g., liver, kidney, lung, spleen, bone marrow) during HER2-targeted PET/CT imaging.
Units of Measure: SUVmean (unitless)
Measured: Day 1 post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20251 Dec 2026

First posted17 Jun 2025
Study start1 Jul 2025 (estimated)
Primary completion7 Jul 2026 (estimated)
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies 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: Early Phase 1
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07023861
Sponsor's protocol ID: LS2024583
Status last verified: Feb 2025
First submitted: 12 May 2025
Last updated: 17 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Exploration of Novel Radionuclide-labeled HER2-targeting Antibodies in the Diagnosis of HER2-positive Malignancies
ClinicalTrials.gov ID: NCT07023861
Acronym / sponsor ID: LS2024583
Conditions: Breast Cancer, Gastric Cancer (GC), Urothelial Carcinoma (UC)
Keywords: breast cancer, Gastric Cancer (GC), Urothelial carcinoma (UC), HER2, PET/CT, 89Zr
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 20 participants (estimated)
Lead sponsor: Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
Study start: 1 Jul 2025 (estimated)
Primary completion: 7 Jul 2026 (estimated)
Study completion: 1 Dec 2026 (estimated)
First posted: 17 Jun 2025 (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.

The purpose of this study is to develop and clinically evaluate 89Zr-labeled HER2-targeted antibodies in diagnosis and screening of HER2-positive cancer patients.

Detailed description

Main objectives:

Application of novel radionuclide-labeled HER2-targeting antibodies (89Zr-LNCab002, 89Zr-LNCab072, 89Zr-LNCab190) in the early diagnosis of breast cancer, gastric cancer, urothelial carcinoma and other diseases;
To evaluate the efficacy, safety and dosimetry of 89Zr-LNCab002, 89Zr-LNCab072, 89Zr-LNCab190 in clinical PET imaging applications.

Secondary Objectives:

To investigate the biodistribution of 89Zr-LNCab002, 89Zr-LNCab072 and 89Zr-LNCab190 in patients with breast cancer, gastric cancer and urothelial carcinoma, including the distribution of primary and metastatic tumors and normal tissues, through the evaluation of whole-body imaging and SUV values using PET/CT imaging.
Compared with 18F-FDG, the clinical application value and diagnostic advantages of the novel radionuclide-labeled HER2-targeting antibodies 89Zr-LNCab002, 89Zr-LNCab072 and 89Zr-LNCab190 were evaluated.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
89Zr-LNCab190	Experimental	Drug: 18F-FDG, Drug: 89Zr-LNCab19089Zr-LNCab190 injection (1-3 mCi) was injected intravenously for 45-60s.
89Zr-LNCab002	Experimental	Drug: 18F-FDG, Drug: 89Zr-LNCab00289Zr-LNCab002 injection (1-3 mCi) was injected intravenously for 45-60s.
89Zr-LNCab072	Experimental	Drug: 18F-FDG, Drug: 89Zr-LNCab07289Zr-LNCab072 injection (1-3mCi) was injected intravenously for 45-60s.
18F-FDG	Active comparator	Drug: 89Zr-LNCab190, Drug: 89Zr-LNCab002, Drug: 89Zr-LNCab072The corresponding patients underwent HER2 PET/CT examination within one week before and after routine 18F-FDG PET/CT imaging (control examination). PET/CT whole body scan was performed 45 min-1 h after intravenous injection of the developer, and the image processing was as usual.

Who may qualify

Ages: 15 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Subjects voluntarily signed the informed consent form and was able to complete the trial according to the protocol requirements ;
18-75 years old, male or female ;
Clinical diagnosed with gastric cancer, breast cancer, urothelial carcinoma, diagnostic criteria refer to biopsy, and HER2 immunohistochemistry result is positive ;
Presence of at least one measurable lesion in the subject's body, which can be accurately and continuously measured by the modified RECIST criteria (version 1.1) ;
ECOG score of 0-3 ;

Key exclusion criteria (13 listed)

Those who are not suitable for PET/CT examination or cannot complete PET/CT examination for special reasons, including but not limited to claustrophobia, radiophobia, etc ;
Those who cannot tolerate intravenous administration (such as history of needle sickness and blood sickness) ;
Known allergy to chimeric or human antibodies or fusion proteins, or other excipients
Presence of any of the following: a) brain metastases (except for primary or metastatic brain tumors that are asymptomatic and do not require treatment); b) carcinomatous meningitis; c) diabetes mellitus with poor glycemic control; d) Myocardial infarction within 6 months prior to screening; e) unstable angina; f) Have a previous uncontrollable cardiac arrhythmia or are currently at high risk; g) Prior coronary artery bypass grafting; h) Cerebrovascular accident within 6 months prior to screening; i) congestive heart failure (cardiac function class III-IV); j) pulmonary embolism; k) deep vein thrombosis) concomitant infection requiring intravenous antibiotic treatment within 2 weeks prior to screening; m) History of immunosuppressant therapy after organ transplantation ;
Those who have had or are currently concomitant with primary central nervous system tumors ;

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
18F-FDG18F-FDG is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15 mCi/kg.	Drug	89Zr-LNCab002, 89Zr-LNCab072, 89Zr-LNCab190
89Zr-LNCab19089Zr-LNCab190 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi	Drug	18F-FDG, 89Zr-LNCab190
89Zr-LNCab00289Zr-LNCab002 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi	Drug	18F-FDG, 89Zr-LNCab002
89Zr-LNCab07289Zr-LNCab072 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi	Drug	18F-FDG, 89Zr-LNCab072

Primary outcome

Tumor Uptake Value (SUVmax) of HER2-Targeted PET/CT Compared with 18F-FDG PET/CT
Time frame: Day 1 post-injection
The maximum standardized uptake value (SUVmax) of identified lesions on HER2-targeted PET/CT using 89Zr-LNCab190, 89Zr-LNCab002, and 89Zr-LNCab072 will be measured and compared with the SUVmax of lesions detected on 18F-FDG PET/CT imaging in the same patients. Units of Measure: SUVmax (unitless)
Number of Lesions Detected by HER2-Targeted PET/CT Compared with 18F-FDG PET/CT
Time frame: Day 1 post-injection
The number of lesions detected by HER2-targeted PET/CT using 89Zr-labeled antibodies will be recorded and compared to the number of lesions detected by 18F-FDG PET/CT imaging in the same patient population. Units of Measure: Number of lesions

1 secondary outcome

Biodistribution of 89Zr-Labeled HER2-Targeted Antibodies in Normal Organs
Time frame: Day 1 post-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 17 Jun 2025.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 18F-FDG, 89Zr-LNCab190 and 89Zr-LNCab002 in people with Breast Cancer and Gastric Cancer (GC), run by Affiliated Hospital of Jiangnan University 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 8 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: enrolling by invitation, as of the sponsor's last update on 17 Jun 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Uptake Value (SUVmax) of HER2-Targeted PET/CT Compared with 18F-FDG PET/CT (time frame: Day 1 post-injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07023861.

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 17 Jun 2025.