NCT06394713尚未招募1 期
A Phase 1b/2 Trial to Evaluate the Efficacy and Safety of QLF31907 (PD-L1/4-1BB Bi-specific Antibody) Combination Therapy in Patients With Advanced Malignant Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- phase Ib: Dose-limiting toxicity(DLT)
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant 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
- •subjects voluntarily participated and signed a written informed consent form;
- •age ≥18 years, male or female;
- •ECOG PS 0-1;
- •histopathologically diagnosed advanced malignant tumors;
- •at least 1 measurable lesion according to RECIST v1.1 criteria or Lugano (2014) criteria;
- •adequate organ function;
排除标准
- •previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein;
- •received anti-tumor therapy within 4 weeks prior to the first study treatment;
- •history of autoimmune disease;
- •history of other active malignancies within 3 years prior to the first treatment;
- •history of serous cardiovascular events;
研究组 & 干预措施
QLF31907 in combination with Irinotecan
Experimental
干预措施: QLF31907 (Drug)
QLF31907 in combination with Irinotecan
Experimental
干预措施: Irinotecan (Drug)
QLF31907 in combination with Docetaxel
Experimental
干预措施: QLF31907 (Drug)
QLF31907 in combination with Docetaxel
Experimental
干预措施: Docetaxel (Drug)
结局指标
主要结局
phase Ib: Dose-limiting toxicity(DLT)
时间窗: 28 days
The DLT of QLF31907 combination therapy will be determined
phase2: objective response rate(ORR)
时间窗: up to 2 years
the ORR of QLF31907 combinaton therapy will be determined
次要结局
- adverse events (AEs) of QLF31907 combination therapy(up to 2 years)
- maximum plasma concentration (Cmax) of QLF31907(up to 2 years)
- Immunogenicity of QLF31907(up to 2 years)
- overall survival(OS)(up to 2 years)
- area under the concentration-time curve (AUC) of QLF31907(up to 2 years)
研究者
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