A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 39
- 主要终点
- Adverse Events
研究概览
简要总结
This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •1.18 years of age or older.
- •Histologically or cytologically confirmed diagnosis of ES-SCLC
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Adequate hematologic and end-organ function
排除标准
- •No prior systemic anti-cancer treatment for ES-SCLC
- •No prior treatment targeting B7H3 or topoisomerase I inhibitor
- •No clinically active brain metastases or spinal cord compression
- •No current or history of interstitial lung disease (ILD)/ pneumonitis
- •No clinically significant cardiovascular disease (eg, New York Heart Association class II to IV congestive heart failure)
- •Other protocol-defined inclusion/ exclusion criteria may apply.
研究组 & 干预措施
YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W
干预措施: Atezolizumab (Drug)
YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W
干预措施: YL201 (Drug)
YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W
干预措施: YL201 (Drug)
YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W
干预措施: Atezolizumab (Drug)
YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W
干预措施: Atezolizumab (Drug)
YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W
干预措施: YL201 (Drug)
结局指标
主要结局
Adverse Events
时间窗: First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)
Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5
Nature and Frequency with Dose-Limiting Toxicities (DLTs)
时间窗: 21 days
次要结局
- ORR(Up to approximately 3 years)
- DOR(Up to approximately 3 years)
- PFS(Up to approximately 3 years)
- OS(Up to approximately 3 years)
- AUC(Up to approximately 3 years)
- CL(Up to approximately 3 years)
- Vss(Up to approximately 3 years)
- t1/2(Up to approximately 3 years)
- Cmax(Up to approximately 3 years)