A Phase IIa Clinical Study to Assess the Efficacy and Safety of SC-101 in Patients With Advanced Malignant Tumors Positive for NECTIN4 Gene Amplification
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- cORR
研究概览
简要总结
This study is an open-label, multicenter Phase IIa trial to evaluate the efficacy and safety of SC-101 monotherapy in patients with locally advanced or metastatic malignant tumors who are positive for NECTIN4 gene amplification.
详细描述
The study will include multiple cohorts: triple-negative breast cancer (TNBC), HR-positive HER2-negative breast cancer, and other solid tumors.
Participants will receive SC-101 at a dose of 7.5 mg/m² once weekly, with treatment cycles lasting 28 days. The study aims to assess tumor response and safety until disease progression or other reasons for treatment discontinuation.
Eligibility requires patients to have locally advanced or metastatic tumors that have either relapsed after standard treatment, are resistant to treatment, or are not amenable to standard treatment. NECTIN4 gene amplification must be confirmed via tumor tissue testing.
Imaging assessments will be conducted every 8 weeks to evaluate tumor response. Safety follow-up will be performed 30 days after the last dose, with additional survival follow-ups every 12 weeks thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years (inclusive), regardless of gender.
- •ECOG performance status of 0-
- •Expected survival of more than 3 months, as assessed by the investigator.
- •Fertile participants must agree to use contraception.
- •Able to understand the trial requirements and willing and able to comply with the trial and follow-up procedures.
- •Adequate bone marrow and organ function.
- •NECTIN-4 gene amplification positive.
排除标准
- •Unstable central nervous system tumors.
- •Adverse reactions from previous anticancer treatments have not recovered to a CTCAE 5.0 grade ≤
- •A history of severe cardiovascular or cerebrovascular disease.
研究组 & 干预措施
TNBC, HR+HER2- BC, and other tumors
Receive 7.5 mg/m² of SC-101 intravenously once weekly (QW).
干预措施: SC-101 (Drug)
结局指标
主要结局
cORR
时间窗: Baseline (Day -28 to Day -1); tumor response will be evaluated every 8 weeks (±7 days) from the first dose of study treatment to the data cut-off date, up to 24 months.
Investigator-assessed confirmed objective response rate
次要结局
未报告次要终点