Trastuzumab Rezetecan Alone or in Combination for the Treatment of Patients With Recurrent or Metastatic Malignant Solid Tumors Expressing HER-2 Protein: A Single-Center, Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety （Incidence of Grade ≥3 AEs）
研究概览
简要总结
To Observe and Evaluate the Safety Profile of Trastuzumab Rezetecan Alone or in Combination in Patients with HER-2 Protein-Expressing Recurrent or Metastatic Malignant Solid Tumors in a Real-World Setting.
详细描述
Trastuzumab Rezetecan specifically binds to HER2 on the surface of tumor cells. The conjugate is subsequently internalized into the cells and transported to lysosomes, where the linker is cleaved by cathepsins to release the free toxin SHR169265. This payload inhibits the activity of DNA topoisomerase I, thereby inducing apoptosis in tumor cells. Owing to the high membrane permeability of SHR169265, a bystander killing effect is also observed: after being released inside tumor cells, it can diffuse into neighboring cells, exerting cytotoxic effects even on HER2-negative cells. This study aims to evaluate the efficacy and safety of Trastuzumab Rezetecan, either as monotherapy or in combination regimens, in patients with HER2-expressing recurrent or metastatic malignant solid tumors.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form voluntarily and agree to participate in this study.
- •Histologically or cytologically confirmed diagnosis of advanced solid tumor.
- •Age ≥ 18 years.
- •HER2 protein expression (including IHC 1+, IHC 2+, IHC 3+, or IHC 0 with ≤10% of invasive tumor cells showing incomplete/weak membrane staining). HER2 protein expression test results must be within 2 years.
- •Patients with advanced solid tumors who have failed, are intolerant to, or refuse standard therapy, and are deemed by the investigator as suitable to receive Trastuzumab Rezetecan monotherapy or combination therapy.
排除标准
- •Patients who are concurrently receiving other therapies of the same class.
- •Patients currently enrolled in another interventional clinical study.
- •Females with confirmed pregnancy or during lactation.
- •Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this study.
研究组 & 干预措施
Treatment arm
Trastuzumab Rezetecan: ± Other Drugs
干预措施: Other Drugs (Drug)
Treatment arm
Trastuzumab Rezetecan: ± Other Drugs
干预措施: Trastuzumab Rezetecan (Drug)
结局指标
主要结局
Safety （Incidence of Grade ≥3 AEs）
时间窗: From the first dose on Day 1 through the last dose, for up to 3 years
Safety （Incidence of Grade ≥3 AEs）
次要结局
- ORR(from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, or initiation of other anti-tumor treatment, whichever occurs first, up to 6 months)
- PFS(From the first vaccination to the first recorded disease progression or death, the assessment period was up to 36 months.)
- OS(from the date of the first dose to the date of death for any reason, up to 3 years)
- iORR(From the first dose until the occurrence of intracranial progression or death (whichever occurs first), assessed up to 6 months.)
- iPFS(From the date of the first dose to the date of the first documented intracranial progression, assessed for up to 3 years.)
研究者
Lixiaoling
Chief Physician
Beidahuang Industry Group General Hospital