NCT05323045已完成1 期
A First-in-human Dose-escalation and Expansion Trial With the Antibody-drug Conjugate BYON3521 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With c-MET Expressing Locally Advanced or Metastatic Solid Tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Byondis B.V.
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Incidence of dose-limiting toxicities
研究概览
简要总结
This is the first-in-human trial with BYON3521, an antibody-drug conjugate (ADC) comprising a humanized IgG1 monoclonal antibody directed against the c-MET receptor covalently conjugated to a duocarmycin-containing linker-drug.
详细描述
This trial includes a dose-escalation part (Part 1) in which the MTD and RDE will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts.
BYON3521 is an ADC comprising a humanized IgG1 monoclonal antibody (mAb) directed against the c-MET receptor covalently and site-specifically conjugated to a duocarmycin-containing linkerdrug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with histologically-confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists:
- •Part 1 (dose-escalation): solid tumours of any origin;
- •Part 2 (expansion):
- •Cohort A: Non-squamous non small cell lung cancer (non-squamous NSCLC);
- •Cohort B: Gynaecological cancers: ovarian cancer, endometrial cancer, cervical cancer;
- •Cohort C: Pancreatic adenocarcinoma (PA);
- •Cohort D: Uveal melanoma (UM).
- •c-MET prevalence confirmed by:
- •Part 1: Tumour c-MET positive membrane staining by immunohistochemistry (IHC) and/or MET amplification by dual In Situ Hybridization (dISH) and/or known MET-mutation;
- •Part 2: Tumour c-MET membrane expression by immunohistochemistry (IHC score ≥ 2+) as determined by the central laboratory on most recent available/obtained tumour material from a site not previously irradiated;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
- •Adequate organ function
排除标准
- •Having been treated with:
- •Trastuzumab duocarmazine (SYD985) at any time;
- •Other anticancer therapy within 4 weeks or as defined in the protocol;
- •History or presence of keratitis, glomerulonephritis, 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 (within 6 months prior to start IMP) or presence of clinically significant cardiovascular disease such as unstable angina, congestive heart failure, myocardial infarction, uncontrolled hypertension, or cardiac arrhythmia requiring medication;
- •Symptomatic brain metastases, brain metastases requiring steroids or treatment for brain metastases within 8 weeks
研究组 & 干预措施
BYON3521
Experimental
c-MET targeting Antibody-Drug Conjugate
干预措施: BYON3521 (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities
时间窗: 21 days
Part 1
次要结局
- Objective response rate(21 days)
研究者
研究点 (4)
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