NCT07552376尚未招募1 期
A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS1317 in Participants With Advanced Solid Tumors Characterized by Microsatellite Instability-High (MSI-H)/Deficient DNA Mismatch Repair (dMMR) Advanced Solid Tumors
Shanghai Qilu Pharmaceutical Research and Development Center LTD0 个研究点目标入组 120 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Recommended Phase ll Dose（RP2D）
研究概览
简要总结
The goal of this study aims to evaluate the efficacy and safety of QLS1317 in patients with MSI-H/dMMR advanced solid tumors who failed standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Males or females aged ≥ 18 at the time of signing the informed consent form (ICF).
- •2. Expected survival duration ≥ 3 months.
- •Participants with advanced solid tumors of MSI-H/dMMR who have failed standard treatment.
- •4. At least one measurable lesion according to RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) physical performance status score of 0-
- •6. Patients with sufficient organ function.
排除标准
- •1. Have a history of allergy to any component of the study drug.
- •Oral medication is not allowed.
- •The residual toxic reactions caused by previous anti-tumor treatment are higher than Grade 1 according to CTCAE v6.
- •4. Known or discovered during screening period to have active central nervous system metastasis.
- •5. Having suffered from other malignant tumors within 5 years prior to the first dose.
- •6. The presence of uncontrollable pleural effusion, pericardial effusion, or ascites that require drainage or treatment.
- •7. Chronic active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
- •8. Suffering from severe cardiovascular and cerebrovascular diseases.
- •Any severe or uncontrollable systemic disease.
- •Have received allogeneic tissue/solid organ transplantation.
研究组 & 干预措施
QLS1317
Experimental
干预措施: QLS1317 (Drug)
结局指标
主要结局
Recommended Phase ll Dose（RP2D）
时间窗: 2 years
Objective Remission Rate (ORR)
时间窗: 2 years
Dose-Lmiting Toxicity (DLT),
时间窗: From time of first dose of QLS1317 to end of DLT period (25 days)
Maximum Tolerated Dose (MTD)
时间窗: 1 year
次要结局
未报告次要终点
研究者
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