EUCTR2020-005575-12-BE进行中（未招募）1 期
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
- 进行中（未招募）
- 发起方
- Byondis B.V.
- 入组人数
- 205
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 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 be able to self-administer eye drops up to 6-times daily or should have adequate daily assistance available (e.g. caregiver) to administer the eye drops;
- •6. Patient should refrain from wearing any kind of contact lenses during trial treatment;
- •7. Adequate organ function, evidenced by the following laboratory results:
- •– Absolute neutrophil count = 1.5 x 109/L;
- •– Platelet count = 100 x 109/L;
- •– Hemoglobin = 9.0 g/dL or 5.6 mmol/L;
- •– Total bilirubin = 1.5 x the upper limit of normal (ULN);
- •– Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3.0 x ULN (or = 5.0 x ULN in the presence of liver metastases);
- •– Serum creatinine = 1.5 x ULN;
- •8. For women of childbearing potential and male patients with a female partner of childbearing potential, highly effective contraception must be used during the trial and up to at least 6 months after last IMP treatment. This is not required in case the patient or sole partner is surgically sterilized or in case the patient truly abstains from sexual activity.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 164
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •Exclusion criteria
- •1. Having been treated with:
- •a. DUBA-containing antibody-drug conjugates (ADCs) at any time;
- •b. Anthracycline treatment within 8 weeks prior to start SYD985 treatment;
- •c. Other anticancer therapy including chemotherapy, immunotherapy, or investigational agent within 4 weeks prior to start SYD985 treatment or within 5 times the half-life of the therapy, whatever is shorter;
- •d. Radiotherapy within 4 weeks prior to start SYD985 treatment, or within 1 week for palliative care (as long as the lungs were not exposed);
- •e. Hormone therapy (except for luteinizing hormone-releasing hormone agonists for prostate cancer or premenopausal breast cancer) within 1 week prior to start SYD985 treatment;
- •The patient must have sufficiently recovered from any treatment-related toxicities to CTCAE Grade =1 or baseline, except for toxicities not considered a safety risk for the patient at the investigator’s discretion;
- •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% as assessed by either echocardiography or multigated acquisition (MUGA) scan at screening, 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 (within 6 months prior to start SYD985) or presence of clinically significant cardiovascular disease such as unstable angina, congestive heart failure, myocardial infarction, uncontrolled hypertension, or cardiac arrhythmia requiring medication;
- •7. Severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) at screening;
- •8. Symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to start SYD985 treatment;
- •9. Positive COVID-19 test within 8 weeks prior to start SYD985 treatment, presence of clinically significant symptoms of confirmed or unconfirmed suspected COVID-19 infection at screening (regardless if and when patient was tested), presence of COVID-19 related signs on screening chest CT scan, or need for continued supportive medication for past COVID-19 infection;
- •10. Known active Hepatitis B, C or E infection at screening;
- •11. Major surgery within 4 weeks prior to start SYD985 treatment;
- •12. Pregnancy or lactation;
- •13. Other condition, which in the opinion of the investigator, would compromise the safety of the patient or the patient’s ability to complete the trial.
研究者
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