[68Ga]Ga-ABY-025 PET in solid tumors

Trial details

Who runs it

Karolinska University Hospital

Trial code

EU 2022-500448-39-00

Record updated

2025. május 9.

Original description

To evaluate the HER2 status in lesions (primary tumors and/or metastases) measured by [68Ga]Ga-ABY-025-uptake on PET/CT in patients with GEAC and HER2-low mBC (combined and individual cohorts respectively). The HER2 status defined by IHC-status and ISH-analyses will be used as a reference standard.Read full original descriptionShow less

Phase II study of [68Ga]Ga-ABY-025 PET for non-invasive quantification of HER2-status in solid tumors.

To evaluate the HER2 status in lesions (primary tumors and/or metastases) measured by [68Ga]Ga-ABY-025-uptake on PET/CT in patients with GEAC and HER2-low mBC (combined and individual cohorts respectively). The HER2 status defined by IHC-status and ISH-analyses will be used as a reference standard.

Inclusion: Age ≥18 years; The subject has given written consent to participate in the study; Patients with metastatic disease because of gastroesophageal adenocarcinoma, NSCLC or HER2-low breast cancer. Cohort 1: Histologically confirmed HER2-positive primary gastroesophageal adenocarcinoma, scheduled for palliative HER2-targeted therapy; Cohort 2: HER2-positive status in non-small cell lung cancer, scheduled for palliative HER2-targeted therapy; Cohort 3: HER2-low metastatic breast cancer first within a pilot study (of which five patients with de novo HER2-low mBC and five patients with pre-treated HER2-low mBC). Later, within a post-pilot study. For definition of HER2 status in each cohort see Supplement 16.b; At least one metastatic lesion ≥ 10 mm is available for biopsy defined on CT; At least one (and up to five) additional metastatic index lesion/s ≥ 10 mm for evaluation of treatment effect; WHO performance status ≤ 2; Expected survival > 12 weeks.

Exclusion: Positive pregnancy test in women of childbearing potential (premenopausal or <12 months of amenorrhea post-menopause and who have not undergone surgical sterilization) or lactation; Allergy to iodinated contrast media; Subjects that for some reason are unable to exercise their rights, such as cognitive function impairment; Other manifest malignancy except for basal cell carcinoma of the skin; Female patients of childbearing potential and sexually active and not willing to use a highly effective contraceptive. Examples of highly effective contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period; Significantly impaired renal function (GFR <30 ml/min/1.73 m2); The patient presenting any contraindication for the use of HER2 targeted therapy for metastatic disease: congestive heart failure, baseline left ventricular ejection fraction (LVEF) less than 50%, transmural myocardial infarction, uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg), angina pectoris requiring medication, clinically significant valvular heart disease, high-risk arrhythmias, lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, active gastrointestinal bleeding; Inadequate organ function, suggested by the following laboratory results: absolute neutrophil count <1,500 cells/mm3, haemoglobin <90 g/L, total bilirubin ≥1.5 x ULN (unless the patient has documented Gilbert’s syndrome), AST (SGOT) or ALT (SGPT) >5.0 x ULN; Patients with increased risk of complications from biopsies, i.e. increased risk of bleeding, defined as - prothrombin time test (INR value) >1.4, platelet count <70 (109/l), activated partial thromboplastin time (APTT) >30s. - known bleeding disorder such as hemophilia, von Willebrand disease or platelet disorders. - any anticoagulants or antiplatelet treatment (except for low-dose ASA, i. e 75 mg daily).

EU CTIS 2022-500448-39-00