An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of WEF-001 in Participants With Advanced KRAS- Mutant Solid Tumours.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- Phase 1: To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy.
研究概览
简要总结
This is a study designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of WEF-001 as monotherapy in patients with Advanced KRAS-mutant solid tumours.
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
- •Advanced KRAS-mutant solid tumor: pancreatic ductal adenocarcinoma, colorectal cancer, non small cell lung cancer, platinum-resistant serous ovarian cancer, cholangiocarcinoma or urothelial bladder cancer
- •Progressive disease following at least one line of standard of care therapy
- •Measurable disease as defined by RECIST v1.1
排除标准
- •Active systemic infection requiring anti-infective therapy within 28 days prior to first dose of IMP
- •Active cardiovascular disease
- •Having a second active primary malignancy, requiring systemic administration of any cancer-related therapy
- •Liver dysfunction
- •Untreated brain metastasis and/or unstable neurological dysfunction
- •Inflammatory bowel disease
- •Active and untreated hyperthyroidism
- •Lupus erythematosus within past 5 years
研究组 & 干预措施
Dose selection
Phase 1: WEF-001 will be administered to participating patients at 1 selected dose out of 7 possible doses.
Phase 2: WEF-001 will be administered to participating patients at 1 selected dose out of 2 possible doses.
干预措施: WEF-001 (Drug)
结局指标
主要结局
Phase 1: To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy.
时间窗: Through study completion, an average of 1 year.
Type, incidence and severity of TEAEs, SAEs and abnormal laboratory values per CTCAE v5.0. Frequency of dose interruptions, reductions, and discontinuations. Proportion of participants with DLTs at each dose level.
Phase 2: To evaluate the antitumour activity following WEF-001 administration as monotherapy.
时间窗: Trough study completion, an average of 2 years.
Objective Response Rate according to Response Evaluation Criteria in Solid Tumor (RECIST) v 1.1
次要结局
未报告次要终点