NCT07591285尚未招募1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYS6051 in Patients With Advanced Solid Tumors
CSPC Megalith Biopharmaceutical Co.,Ltd.0 个研究点目标入组 114 人开始时间: 2026年5月12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
- 114
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
This is a multicenter, open-label, dose-escalation and backfill, and cohort-expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of SYS6051 in participants with 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
- •Fully understand the clinical study and voluntarily sign the written ICF;
- •Age ≥ 18 years;
- •Have at least one measurable lesion according to RECIST 1.1;
- •ECOG performance status score of 0 to 1;
- •Have adequate organ function;
- •Expected survival of at least 3 months;
- •Eligible participants of childbearing potential must agree to use a reliable method of contraception with their partner during the study and for at least 4 months (males) or 7 months (females) after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose;
- •Histologically or cytologically confirmed diagnosis of advanced solid tumors. -
排除标准
- •1. Presence of high bleeding risk factors;
- •Presence of active ocular disease;
- •Patients with other active malignant tumors;
- •Uncontrolled serous effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose;
- •Serious chronic or active infection;
- •Surgical on vital organs within 4 weeks prior to the first dose or planned systemic or local tumor resection during the study;
- •Untreated (including baseline findings) or unstable parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis;
- •History of non-infectious lung disease/pneumonitis requiring steroid hormone therapy or current interstitial lung disease/pneumonitis or suspected by imaging during screening;
- •History of significant cardiovascular disease;
- •History of immunodeficiency, Active hepatitis B or hepatitis C;
- •Known serious allergic reactions to the study drug or other ingredients and excipients in the formulation;
- •Pregnant or lactating women;
- •Presence of other conditions that could interfere with the participant 's participation in study procedures or would not be in the best interest of the participant' s participation in the study or affect the study results: such as a history of mental illness, drug use, or drug abuse, any other clinically significant disease or condition.
研究组 & 干预措施
SYS6051
Experimental
干预措施: SYS6051 (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: From Day 1 to Day 21
Frequency and severity of AE
时间窗: From Day 1 to 30 days after last dose.
Maximal tolerable dose (MTD)
时间窗: From Day 1 to 12 months.
Recommended phase 2 dose (RP2D)
时间窗: From Day 1 to 12 months.
ORR
时间窗: From Day 1 to 12 months.
次要结局
- Cmax(From Day 1 to 12 months.)
- AUCss,(From Day 1 to 12 months.)
- ORR(From Day 1 to 12 months.)
- PFS(From Day 1 to 12 months.)
- OS(From Day 1 to 18 months.)
- Positive rate for ADA(From Day 1 to 18 months.)
研究者
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