NCT07104877进行中（未招募）不适用
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SYH2051 in Combination With SYS6010 in Patients With Gastrointestinal Tumors Such as Advanced Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adverse Event (AE)
研究概览
简要总结
This study is an open-label, non-randomized trial design, including a dose escalation phase and a dose expansion phase, to evaluate the safety, tolerability and preliminary anti-tumor activity of SYS6010 in combination with SYH2051 in patients with advanced gastrointestinal tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age ≥18 years.
- •Patients with unresectable or metastatic colorectal cancer or other gastrointestinal tumors confirmed by histology or pathology, who have failed at least first-line standard therapy or for whom standard treatment is not applicable.
- •Provide tumor tissue samples for immunohistochemical EGFR expression testing, with EGFR expression positive as confirmed by the central laboratory.
- •At least one measurable lesion confirmed according to RECIST v 1.1 criteria.
- •ECOG performance status score of 0-
- •Expected survival of ≥3 months.
- •Major organ functions must meet relevant laboratory criteria for blood counts, renal function, liver function, and coagulation within 7 days prior to treatment.
- •Subjects agree to use effective contraception during the study and for 6 months after the last dose, with women being non-lactating and men refraining from sperm donation. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first administration of the study drug.
- •Willing to participate in the study, understand the study procedures, and sign a written informed consent form.
排除标准
- •Previously treated with antibody-drug conjugates (ADC) containing topoisomerase I inhibitors.
- •Failure to meet the required washout period for prior medications or treatments as specified in the protocol..
- •Has other primary malignancies within 3 years prior to the first dose of the study drugs.
- •History of severe cardio-cerebrovascular disease.
- •Adverse events from prior anti-tumor treatments that have not resolved to ≤ Grade 1 of CTCAE V5.
- •Patients with active central nervous system and/or leptomeningeal metastases.
- •Clinically significant pleural effusion, peritoneal effusion, or pericardial effusion requiring intervention.
- •Has a history of Interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids, has current ILD/non-infectious pneumonitis, or where suspected ILD/non-infectious pneumonitis cannot be ruled out by imaging at screening.
- •Patients with thyroid dysfunction requiring treatment, but that well-controlled was allowed.
- •Severe infections within 4 weeks prior to the first administration of the study drugs.
- •Prior interruption of EGFR-targeted therapy due to skin toxicity, or skin diseases requiring oral or intravenous treatment currently.
- •Known allergy to any component of SYS6010 or SYH2051, or any humanized monoclonal antibody product.
- •Severe ophthalmic history (e.g., dry eye syndrome, keratitis, conjunctivitis, etc.).
- •Had a history of autoimmune disease (except tuberous sclerosis), immunodeficiency (including positive HIV test), or other acquired or congenital immunodeficiency diseases, or organ transplantation.
- •Active HBV, HCV infection or syphilis infection.
- •Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
研究组 & 干预措施
SYS6010+SYH2051
Experimental
干预措施: SYS6010 (Drug)
SYS6010+SYH2051
Experimental
干预措施: SYH2051 (Drug)
结局指标
主要结局
Adverse Event (AE)
时间窗: Up to 90 days following the last dose
Occurrence and frequency of Adverse Event (AE)The occurrence and incidence of adverse events (AEs) will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. AEs will be monitored from the first dose until the safety follow-up period.
Dose-limiting toxicities (DLTs)
时间窗: Up to 21 days
DLTs are defined as adverse events related to the study drug that meet the protocol-specified criteria for dose limitation.
次要结局
- Objective response rate (ORR) per RECIST v1.1(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Progression-free Survival (PFS)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
研究者
研究点 (1)
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