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SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors

2026年5月30日 更新者：CSPC Megalith Biopharmaceutical Co.,Ltd.

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

264

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Clinical Trials Information Group Officer
  • 电话号码：86-0311-69085587
  • 邮箱：ctr-contact@cspc.cn

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：SYS6006 + Enlonstobart

Phase Ib Dose Escalation Cohort Dose level 1 will consist of 3-6 patients who will receive SYS6006 and Enlonstobart.

Dose level 2 will consist of 3-6 patients who will receive SYS6006 and Enlonstobart.

  1. If 0/3 participants experience a DLT, the next 3 participants can be enrolled to receive the same dose regimen, and escalation to the next dose group may proceed;

  2. If 1/3 participants experience a DLT, an additional 3 participants will be enrolled to continue evaluation at the same dose regimen:

    If a final total of 1/6 participants experience a DLT, escalation to the next dose group may proceed; If ≥2 of the 6 evaluable participants experience a DLT, escalation will be stopped;

  3. If ≥2/3 participants experience a DLT, escalation will be stopped.

Phase II Investigational Treatment:The maximum safe dose of SYS6006 in combination Enlonstobart (as determined in the phase Ib cohort).
生物：SYS6006
Drug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection
其他名称：
  • SYS6006 injection
生物：Enlonstobart
Enlonstobart IV
其他名称：
  • Enlonstobart injection
有源比较器：Enlonstobart
Phase II Investigational Treatment:Enlonstobart Intravenous infusion
生物：Enlonstobart
Enlonstobart IV
其他名称：
  • Enlonstobart injection

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Phase Ib: Incidence and frequency of dose-limiting toxicities (DLTs) during the study (applicable to the combination therapy dose-escalation phase)
大体时间：Within 21 days after the start of the treatment
Within 21 days after the start of the treatment
Phase Ib: Incidence and frequency of treatment-emergent adverse events (TEAEs) .
大体时间：Through study completion, an average of l year
Through study completion, an average of l year
Phase Ib:Incidence and frequency of serious adverse events (SAEs)
大体时间：Through study completion, an average of l year
Through study completion, an average of l year
Phase Ib:Maximum tolerated dose (MTD)
大体时间：Every 21 days while on treatment (estimated 6 months)
Every 21 days while on treatment (estimated 6 months)
Phase Ib: Recommended Phase II dose (RP2D)
大体时间：Every 21 days while on treatment (estimated 6 months)
Every 21 days while on treatment (estimated 6 months)
Phase II: ORR as assessed by the investigator according to RECIST v1.1
大体时间：through study completion, an average of 1year.
through study completion, an average of 1year.
Phase II: Incidence and frequency of TEAEs.
大体时间：through study completion, an average of l year
through study completion, an average of l year
Phase II:Incidence and frequency of SAEs.
大体时间：through study completion, an average of l year
through study completion, an average of l year

次要结果测量

结果测量
大体时间
Disease control rate (DCR) per RECIST 1.1
大体时间：Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
Duration of response (DoR) per RECIST 1.1
大体时间：Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
Progression free survival (PFS) per RECIST 1.1
大体时间：Up to approximately 24months after the first participant is enrolled
Up to approximately 24months after the first participant is enrolled
Time to response(TTR)
大体时间：Up to approximately 24months after the first participant is enrolled
Up to approximately 24months after the first participant is enrolled
Overall survival(OS)
大体时间：Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
Frequency and severity of adverse events (AEs) (NCI CTCAE 5.0)
大体时间：Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
PK parameters: The plasma concentration of enlonstobart
大体时间：Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
Correlation between PD-L1 expression level (measured as Tumor Proportion Score [TPS] by 22C3 IHC assay) and objective response rate (ORR, as assessed by RECIST 1.1 criteria)
大体时间：Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
To evaluate changes in cytokines such as interferon-alpha (IFNα) and the activation status of peripheral blood immune cells
大体时间：through study completion, an average of l year
through study completion, an average of l year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

CSPC Megalith Biopharmaceutical Co.,Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月29日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2030年1月31日

研究注册日期

首次提交

2026年5月17日

首先提交符合 QC 标准的

2026年5月30日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月30日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SYS6006-009

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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