Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985

This is an interventional prevention trial for Metastatic Breast Cancer Read More

Main Inclusion Criteria:

1. Male or female, age ≥18 years at the time of signing first informed consent;

2. Patient with histologically-confirmed, unresectable locally advanced or metastatic cancer with the following restriction:

   Single arm part: patient with solid tumours of any origin (excluding gastric tumours and adenocarcinomas of the gastroesophageal junction) who has progressed on standard therapy or for whom no standard therapy exists; Randomized part: patient with breast cancer who had either progression during or after at least two human epidermal growth factor receptor 2 (HER2)-targeting treatment regimens for locally advanced or metastatic disease, or progression during or after [ado-]trastuzumab emtansine treatment for locally advanced or metastatic disease;

3. HER2 tumour status as determined by a local laboratory using immunohistochemistry (IHC) and/or in situ hybridization (ISH):

   Single arm part: at least IHC 1+; Randomized part: IHC 3+ and/or ISH positive;

4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
5. Patient should refrain from wearing any kind of contact lenses during trial treatment;
6. Adequate organ function

Main Exclusion Criteria:

1. Current or previous use of prohibited medication as listed in the protocol
2. History of infusion-related reactions and/or hypersensitivity to trastuzumab containing treatment or excipients of the trial treatments which led to permanent discontinuation of the treatment;
3. History or presence of keratitis;
4. Left ventricular ejection fraction (LVEF) < 50%, or a history of clinically significant decrease in LVEF during previous trastuzumab containing treatment leading to permanent discontinuation of treatment;
5. History or presence of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan;
6. History or presence of clinically significant cardiovascular disease;
7. Severe, uncontrolled systemic disease;
8. Symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks.