HER2-positive recurrent/metastatic breast cancer and gastric cancer
Conditions
Interventions
Native conformation:64Cu-Labeled Novel HER2-Targeted minibinder (Native Conformation)
ABD1 conformation:64Cu-Labeled Novel HER2-Targeted minibinder (ABD1 Conformation)
ABD3 conformation:64Cu-Labeled Novel HER2-Targeted minibinder (ABD3 Conformation)
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.Patients with histologically or cytologically confirmed recurrent/metastatic breast cancer or gastric cancer, with pathological findings indicating HER2-positive status (IHC 2+/3+ or FISH-positive); 3.Presence of at least one measurable lesion (according to RECIST v1.1, as measured by contrast-enhanced CT or magnetic resonance imaging [MRI]; a measurable lesion is defined as a non-lymph node lesion with a longest single diameter >= 10 mm, or a lymph node lesion with a short axis >= 15 mm; lesions previously treated with external radiotherapy or ablation may also serve as measurable target lesions if they have clearly progressed and have a longest diameter >= 10 mm; bone metastases [including identifiable soft tissue components] are not considered measurable lesions); 4.ECOG performance status score of 0–2; 5.Life expectancy >= 3 months; 6.The subject fully understands the purpose, nature, methods, and potential adverse reactions of the study, voluntarily participates and signs written informed consent, and is able to complete the study in accordance with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breastfeeding females; 2.Uncontrolled concurrent diseases; 3.Presence of severe cardiovascular diseases, such as class III–IV heart failure, poorly controlled hypertension, or arrhythmias requiring medication; history of myocardial infarction, angina pectoris, or coronary artery bypass grafting within 6 months prior to the study; 4.Known active hepatitis B or hepatitis C; 5.Organ dysfunction: Bone marrow reserve: absolute neutrophil count (ANC) 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3.0 × ULN (> 5 × ULN in patients with liver metastases); Renal: serum creatinine (SCr) > 1.5 × ULN; 6.Patients with brain metastases who are symptomatic or require corticosteroid therapy to maintain neurological integrity; 7.Presence of other malignancies that may interfere with disease assessment; patients with a prior history of malignancy who have been adequately treated, have remained untreated for more than 3 years prior to enrollment, and have no evidence of recurrence are eligible to participate in the study; 8.Known severe allergy to protein-based agents, or inability to successfully undergo imaging examinations (including PET/CT), including but not limited to claustrophobia or inability to lie flat; 9.Patients for whom pathological or long-term follow-up results may not be obtainable, or for whom relevant comparative imaging data and clinical data are unavailable; 10.Any condition deemed by the investigator to be unsuitable for participation in this clinical study, or any situation that may compromise patient safety; 11.Patients who have received other radionuclides without a washout period of 10 effective half-lives prior to HER2 PET/CT imaging, or who have received radiotherapy within 14 days, or surgery within 21 days, or who have previously received treatment with a product targeting the same epitope.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dosimetry Evaluation;Safety Evaluation;Efficacy Evaluation; | — |
Countries
China
Contacts
Public ContactRui Gao
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed