Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Tox… (NCT04983238) | Clinical Trial Compass
CompletedPhase 1/2
Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985
Belgium, France48 participantsStarted 2022-01-10
Plain-language summary
This multicenter, randomized, double-blind, placebo-controlled trial with a single arm run-in period is to evaluate the safety and efficacy of sodium thiosulfate (BYON5667) eye drops to reduce ocular toxicity in cancer patients treated with the antibody-drug conjugate (ADC) SYD985
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Male or female, age ≥18 years at the time of signing first informed consent;
✓. Patient with histologically-confirmed, unresectable locally advanced or metastatic cancer with the following restriction:
✓. HER2 tumour status as determined by a local laboratory using immunohistochemistry (IHC) and/or in situ hybridization (ISH):
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
✓. Patient should refrain from wearing any kind of contact lenses during trial treatment;
✓. Adequate organ function
Exclusion criteria
✕. Current or previous use of prohibited medication as listed in the protocol
✕. 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;
✕. History or presence of keratitis;
✕. 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;
✕. 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;
What they're measuring
1
Efficacy of BYON5667 eye drops by assessing the percentage of patients with SYD985-related ocular adverse events Grade >=1 at Day 63