Breast CancerEarly Phase 1NCT07023848
PET Image Exploration of 89Zr-labeled Antibody Fragments Targeting HER2 in Patients With Malignant Tumors
A Early Phase 1 study testing 89Zr-LNCab104, 89Zr-LNCab103 and 18F-FDG in people with Breast Cancer and Gastric Cancer (GC), run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
The purpose of this study is to develop and clinically evaluate 89Zr-labeled HER2-targeted antibody fragments in diagnosis and screening of HER2-positive cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Gastric Cancer (GC), Urothelial Carcinoma (UC)
- What is being tested?
- 89Zr-LNCab104, 89Zr-LNCab103 and 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Dec 2026
- Phase
- Early Phase 1
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 75 years
- All sexes
- No healthy volunteers
- 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 ;
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- 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-LNCab103, 89Zr-LNCab104 ;
- 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.
About this study
The purpose of this study is to develop and clinically evaluate 89Zr-labeled HER2-targeted antibody fragments in diagnosis and screening of HER2-positive cancer patients.
Read the detailed description
The following is a detailed description of the objectives of the study:
Main objectives:
- Application of novel radionuclide-labeled HER2-targeting molecular probes (89Zr-LNCab103 and 89Zr-LNCab104) in the early diagnosis of breast cancer, gastric cancer, urothelial carcinoma and other diseases;
- To evaluate the efficacy, safety and dosimetry of 89Zr-LNCab103 and 89Zr-LNCab104 in clinical PET imaging applications.
Secondary Objectives:
- To investigate the biodistribution of 89Zr-LNCab103 and 89Zr-LNCab104 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 molecular probes 89Zr-LNCab103 and 89Zr-LNCab104 were evaluated.
- Being tested
- 89Zr-LNCab104, 89Zr-LNCab103, 18F-FDG
- 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.
89Zr-LNCab104Drug
89Zr-LNCab104 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi
89Zr-LNCab103Drug
89Zr-LNCab103 is administered through a superficial dorsal vein, and the patient is given a dose of about 1-3 mCi
18F-FDGDrug
18F-FDG is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15mCi/kg.
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-LNCab103 | Experimental | 89Zr-LNCab103 injection (1-3mCi) was injected intravenously for 45-60s. Receives: Drug: 89Zr-LNCab103; Drug: 18F-FDG |
| 89Zr-LNCab104 | Experimental | 89Zr-LNCab104 injection (1-3mCi) was injected intravenously for 45-60s. Receives: Drug: 89Zr-LNCab104; Drug: 18F-FDG |
| 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-LNCab104; Drug: 89Zr-LNCab103 |
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-LNCab103 and 89Zr-LNCab104 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-LNCab103 and 89Zr-LNCab104 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.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjing Yu, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023848
- Sponsor's protocol ID
- LS2024548
- Status last verified
- Feb 2025
- First submitted
- 11 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No