NCT05830045招募中1 期
A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Advanced Solid Tumor Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity(DLT)
研究概览
简要总结
This is the first in human study of QLP2117. To evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in patients with advanced 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
- •Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
- •At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Ia dose escalation only requires at least one assessable lesion)
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Agree to provide archived tumor tissue samples of primary or metastatic lesions.
- •Have adequate organ function as described in the protocol.
排除标准
- •Women who are pregnant or breastfeeding
- •HBsAg/HBcAb positive and HBV-DNA>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication
- •Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment
- •Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •Has an active infection requiring systemic therapy
- •Has received a live vaccine wihtin 30 days of planned start of study treatment
- •Has know history of, or any evidence of interstitial lung disease
研究组 & 干预措施
Ia： QLP2117 Dose escalation and PK expansion
Experimental
干预措施: QLP2117 (Drug)
Ib：QLP2117 Dose expansion
Experimental
干预措施: QLP2117 (Drug)
结局指标
主要结局
Dose-limiting toxicity(DLT)
时间窗: 21days
Objective Response Rate for phase 1b
时间窗: up to 96 weeks
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
时间窗: up to 96 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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