NCT07622225尚未招募1 期
A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors
CSPC Megalith Biopharmaceutical Co.,Ltd.0 个研究点目标入组 264 人开始时间: 2026年5月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 264
研究概览
简要总结
This study is a Phase Ib/II clinical study. It includes two stages: Phase Ib and Phase II. In the Phase Ib stage, the primary objective is to evaluate the safety and tolerability of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors, and to provide a basis for dose selection in later clinical studies. The primary objective of the Phase II stage is to assess efficacy and safety of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •1. Able to understand and voluntarily sign the written informed consent form (ICF);
- •2. Male or female subjects aged over 18 years old (inclusive).
- •3. Patients with solid tumor who have unresectable locally advanced or metastatic disease;
- •4. At least one measurable lesion, as defined by RECIST 1.1 criteria;
- •5. ECOG performance status of 0-2;
- •6. Expected survival ≥ 3 months;
- •7. Adequate function of major organs and bone marrow;
- •8. Women or man of childbearing potential must use highly effective contraception.
排除标准
- •1. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
- •2. Patients with a history of autoimmune diseases;
- •3. Presence of active infection (e.g., subjects are receiving anti-infection therapy);
- •4. Severe or uncontrolled cardiovascular disorder requiring treatment;
- •5. Women who are pregnant or breastfeeding.
研究者
相似试验
尚未招募
1 期
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic AnemiaAplastic AnemiaNCT07287228Institute of Hematology & Blood Diseases Hospital, China37
尚未招募
1 期
A Study of BL-M11D1 in Patients With Relapsed/Refractory Myelodysplastic SyndromesMyelodysplastic SyndromesNCT07591168Sichuan Baili Pharmaceutical Co., Ltd.92
招募中
1 期
A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.CRCNCT07283367Hansoh BioMedical R&D Company502
尚未招募
1 期
Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of Advanced Liver CancerNCT07282509CSPC ZhongQi Pharmaceutical Technology Co., Ltd.116
招募中
1 期
A Phase I/III Clinical Study to Evaluate NouvNeu001 Injection for Multiple System AtrophyNCT07289477iRegene Therapeutics Co., Ltd.9