A Multicenter, Randomized, Double-blind, Placebo-controlled Trial With a Single Arm run-in Period to Evaluate the Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Byondis B.V.
- 入组人数
- 48
- 试验地点
- 10
- 主要终点
- Efficacy of BYON5667 eye drops by assessing the percentage of patients with SYD985-related ocular adverse events Grade >=1 at Day 63
研究概览
简要总结
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
详细描述
This multicenter trial has a single arm run-in period followed by a randomized, placebo-controlled, double-blind comparative part. In the single arm part of the trial, patients with HER2-expressing locally advanced or metastatic solid tumours will be enrolled and treated with the antibody-drug conjugate (ADC) SYD985 once every 3 weeks until disease progression or unacceptable toxicity. All patients will receive concomitant BYON5667 eye drops. When the primary safety and efficacy analysis of the BYON5667 eye drops at Day 63 is favorable, the trial may continue to the comparative part in which patients with locally advanced or metastatic HER2-positive breast cancer will be treated with SYD985. Patients will be randomly assigned (1:1) to receive BYON5667 or placebo eye drops.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •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;
- •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;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
- •Patient should refrain from wearing any kind of contact lenses during trial treatment;
- •Adequate organ function
排除标准
- •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;
- •History or presence of clinically significant cardiovascular disease;
- •Severe, uncontrolled systemic disease;
- •Symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks.
研究组 & 干预措施
BYON5667 & SYD985
BYON5667 eye drops should be self-administered daily during waking hours. SYD985, every 3 weeks (Q3W)
干预措施: BYON5667 & SYD985 (Drug)
Placebo & SYD985
Placebo eye drops should be self-administered daily during waking hours. SYD985, every 3 weeks (Q3W)
干预措施: Placebo & SYD985 (Drug)
结局指标
主要结局
Efficacy of BYON5667 eye drops by assessing the percentage of patients with SYD985-related ocular adverse events Grade >=1 at Day 63
时间窗: 63 days
Percentage of patients with SYD985-related ocular toxicity Grade ≥1 at Day 63
次要结局
- Ocular toxicity(Day 63 or Day 126)
- Tolerability of BYON5667 eye drops by means of Eye Drop Tolerability questionnaire scores(Up to 2 years)
- National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores(Up to 2 years)
- SYD985-related ocular adverse events (AE)(Up to 2 years)
- Discontinuation due to SYD985-related ocular toxicity(Up to 2 years)
- Efficacy of SYD985 by assessing the objective response rate (ORR)(Up to 2 years)
- Safety of SYD985 by assessing incidence and severity of treatment-emergent drug-related adverse events(Up to 2 years)
- Efficacy of SYD985 by assessing the progression-free survival (PFS)(Up to 2 years)
- Efficacy of SYD985 by assessing the overall survival(Up to 2 years)