A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 in Patients With Selected Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 594
- 试验地点
- 4
- 主要终点
- Dose limiting toxicities (DLTs)
研究概览
简要总结
The study is a dose-escalation and dose-expansion study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent or in combination with standard of care (SOC) in patients with selected types of advanced solid tumors.
详细描述
Monotherapy:
A dose-escalation (Part A) and expansion (Part B) study of ASKG915 monotherapy was initiated to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with advanced solid tumors.
Combination therapy:
A dose-optimization (Part C) srudy of ASKG915 in combination with standard of care (SOC) in patients was conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with selected types of advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
- •ECOG performance status of ≤
- •Life expectancy of ≥ 3 months.
- •The results of the laboratory tests must meet all criteria.
排除标准
- •Patients have received antitumor therapy during the first 4 weeks before study drug use.
- •Received a live attenuated vaccine within 4 weeks prior to C1D
- •Known cerebral parenchymal metastasis or meningeal metastasis.
- •History of serious cardiovascular or cerebrovascular diseases.
- •Active or recurrent autoimmune diseases.
- •History of ascites or pleural effusion requiring drainage.
- •Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.
研究组 & 干预措施
ASKG915
For monotherapy (Part A and Part B), subjects will receive ASKG915 via intravenous (IV) infusion at a frequency of once every 3 weeks (Q3W) or once every 4 weeks (Q4W), at either the prespecified dose levels or the levels determined by the Study Review Committee (SRC).
干预措施: ASKG915 (Biological)
ASKG915 combination with SOC
For combination therapy phase (Part C), subjects will receive ASKG915 at recommended dose levels via intravenous (IV) infusion, administered once every 3 weeks (Q3W) or once every 4 weeks (Q4W), and in combination with the standard treatment regimen for the selected tumor types.
干预措施: ASKG915 (Biological)
ASKG915 combination with SOC
For combination therapy phase (Part C), subjects will receive ASKG915 at recommended dose levels via intravenous (IV) infusion, administered once every 3 weeks (Q3W) or once every 4 weeks (Q4W), and in combination with the standard treatment regimen for the selected tumor types.
干预措施: Paclitaxel + Bevacizumab (Drug)
ASKG915 combination with SOC
For combination therapy phase (Part C), subjects will receive ASKG915 at recommended dose levels via intravenous (IV) infusion, administered once every 3 weeks (Q3W) or once every 4 weeks (Q4W), and in combination with the standard treatment regimen for the selected tumor types.
干预措施: Fruquintinib (Drug)
ASKG915 combination with SOC
For combination therapy phase (Part C), subjects will receive ASKG915 at recommended dose levels via intravenous (IV) infusion, administered once every 3 weeks (Q3W) or once every 4 weeks (Q4W), and in combination with the standard treatment regimen for the selected tumor types.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Dose limiting toxicities (DLTs)
时间窗: 21days or 28 days
To evaluate the safery of ASKG915 in subjects.
Adverse events(AEs)
时间窗: From the first dose to 30 days after the last dose
To evaluate the safery of ASKG915 in subjects.
次要结局
- Maximum plasma concentration (Cmax)(Until treatment discontinuation or for a maximum of 2 years)
- Area under the concentration time curve (AUC)(Until treatment discontinuation or for a maximum of 2 years)
- Plasma clearance rate (CL)(Until treatment discontinuation or for a maximum of 2 years)
- Evaluation of immunogenicity(Until treatment discontinuation or for a maximum of 2 years)
- Objective Response Rate (ORR)(Until disease progression or for a maximum of 2 years)
- Duration of response (DOR)(Until disease progression or for a maximum of 2 years)
- Progression-free survival (PFS)(Until disease progression or for a maximum of 2 years)