jRCT2031240238招募中不适用
Phase I Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Japanese Patients with Advanced Malignancies associated with Nectin-4 Expression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 主要终点
- Adverse Events
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Eastern Cooperative Oncology Group (ECOG) of 0 or 1
- •Measurable disease as defined by RECIST v1.1
- •Life expectancy >-12 weeks after the start of BT8009 treatment.
- •Must have exhausted all standard treatment options, including appropriate targeted therapies; patients for which no standard therapy is considered appropriate or to provide clinical benefit, as assessed by the Investigator. Patient must have recurred after or been refractory to most recent prior therapy.
- •Patients with advanced, histologically confirmed the following solid tumor:
- •a. urothelial (transitional cell) carcinoma; or
- •b. pancreatic, breast, NSCLC, gastric, esophageal, head and neck, or ovarian tumors
排除标准
- •Current treatment with strong inhibitors or strong inducers of CYP3A or inhibitors of P- gp including herbal- or food-based.
- •Known hypersensitivity to any of the ingredients of the investigational product(s), including MMAE.
- •Active keratitis or corneal ulcerations.
- •Grade >-2 peripheral neuropathy.
- •Uncontrolled diabetes, defined as hemoglobin A1C (HbA1c) >-8%
- •Patients who are pregnant (including those who have been determined to be possibly pregnant based on e.g. a physician's interview) and/or lactating (not allowed to be enrolled even after discontinuation of breastfeeding)
- •Patients with uncontrolled hypertension (systolic blood pressure [BP] Systolic BP >-140 mm Hg or diastolic BP >-90 mm Hg) prior to first dose of BT8009
- •Prior Stevens-Johnson syndrome (SJS)/ toxic epidermal necrolysis (TEN) on any MMAE-conjugated drug
- •Active interstitial lung disease or pneumonitis, or a history of interstitial lung disease or pneumonitis requiring treatment with steroids or other immunosuppressive medications
- •Exclusion Criteria Specific to Part B: Combination with pembrolizumab
- •Prior intolerance or known hypersensitivity to immune checkpoint inhibitor
- •Prior treatment with stimulatory or co-inhibitory T-cell receptor agents, such as CD137 agonists, OX-40 agonist or CTLA-4 inhibitors
- •a. Prior treatment with a PD-1, PD-L1 or PD-L2 inhibitor is permitted
结局指标
主要结局
Adverse Events
Adverse Events as characterized by type, frequency, severity (as graded by CTCAE version 5.0), seriousness, and relationship to BT8009 and/or pembrolizumab.
Laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (as graded by CTCAE version 5.0).
Number of drug-related Adverse Events
时间窗: safety evaluation period
Number of drug-related Adverse Events during safety evaluation period.
PK parameters of BT8009 and MMAE
PK parameters of BT8009 and MMAE as monotherapy and in combination with pembrolizumab, such as maximum concentration (Cmax), area under the curve (AUC), and half-life (t1/2).
次要结局
未报告次要终点
研究者
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