A Phase I Open-label, Multicenter Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 9
- 主要终点
- Adverse events of SAIL66[safety and tolerability]
研究概览
简要总结
This is a Phase 1 dose-escalation and expansion study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of SAIL66 in patients with CLDN6-positive locally advanced or metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age ≥ 18 years at time of signing Informed Consent Form
- •Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
- •Patient must have tumor specimen available for central pathology review and confirmed as CLDN6-positive
- •(For male patients) Agreement to stay abstinent or use contraceptive measures with female partners, and agreement to refrain from donating sprerm during the treatment
排除标准
- •Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, whichever is longer
- •Primary central nervous system (CNS) malignancy, symptomatic (seizures etc.) CNS metastases or CNS metastases required any anti-cancer treatment
- •History or presence of CNS disease such as stroke (e.g., subarachnoid hemorrhage or cerebral infarction), epilepsy, CNS vasculitis, neurodegenerative disease, aphasia, dementia or paresis
- •Uncontrolled tumor-related pain
- •Uncontrolled pleural effusion, pericardial effusion, or ascites
研究组 & 干预措施
Q3W Dose Escalation part
Patients will receive SAIL66 as tri-weekly IV infusions at escalated doses.
干预措施: SAIL66 (Drug)
Expansion part
Patients will receive SAIL66 as a IV infusion at the recommended dose.
干预措施: SAIL66 (Drug)
QW Dose Escalation part
Patients will receive SAIL66 as a weekly IV infusion at escalated doses.
干预措施: SAIL66 (Drug)
结局指标
主要结局
Adverse events of SAIL66[safety and tolerability]
时间窗: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
Incidence, nature, and severity of adverse events graded according to NCI Common Terminology CTCAE v5.0, with severity of CRS determined according to the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Criteria
Change from baseline in vital signs[safety and tolerability]
时间窗: From screening until study completion or treatment discontinuation (approximately 18 weeks)
Change from baseline in vital signs
Change from baseline in clinical laboratory test results and examination findings[safety and tolerability]
时间窗: From screening until study completion or treatment discontinuation (approximately 18 weeks)
Change from baseline in clinical laboratory test results and examination findings specified in this study including, but not limited, electrocardiograms (ECGs)
Dose-limiting toxicities (DLTs) of SAIL66[safety and tolerability]
时间窗: From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)
Incidence and nature of the DLTs \[Q3W Dose Escalation part and QW Dose Escalation part\]
Preliminary anti-tumor activity of SAIL66 when administered at selected dose(s) in each cohort [Expansion part]
时间窗: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)
Objective response rate (ORR), defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) on two consecutive occasions \>= 4 weeks apart, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 by the investigators.
次要结局
- Objective response rate(ORR)[preliminary efficacy](From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks))
- Duration of response (DoR)[preliminary efficacy](From the first occurrence of CR or PR to progression disease (PD) or death from any cause (whichever occurs first)(whichever occurs first) (approximately 18 weeks))
- Maximum serum concentration (Cmax) of SAIL66 [PK profile](From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks))
- Trough serum concentration (Ctrough) of SAIL66 [PK profile](From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks))
- Area under the concentration time-curve (AUC) of SAIL66 [PK profile](From the first occurrence of CR or PR to progression disease (PD) or death from any cause (whichever occurs first) (approximately 18 weeks))
- Disease control rate (DCR)[preliminary efficacy](From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks))
- Immunogenicity of SAIL66[preliminary efficacy](From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation (approximately 18 weeks))
- Progression-free survival (PFS)[preliminary efficacy](From administration of first study treatment to the first occurrence of disease progression or death from any cause (approximately 18 weeks))
- Overall survival (OS)[preliminary efficacy](From administration of first study treatment to death from any cause (approximately 18 weeks))