A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is an open, multicenter Phase II clinical study of SSGJ-707 combined with chemotherapy in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer. The objective is to evaluate the safety, tolerability and antitumor activity of SSGJ-707 in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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:18-75 years old
- •Advanced endometrial cancer and platinum-resistant ovarian cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Expected survival >=12 weeks.
- •Signed informed consent form.
排除标准
- •Known uncontrolled or symptomatic central nervous system metastatic disease.
- •Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.5.0).
- •Inadequate organ or bone marrow function.
- •Pregnant or breast-feeding woman.
- •Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
SSGJ-707(dose 1)+ carboplatin + paclitaxel
干预措施: SSGJ-707 (Drug)
SSGJ-707(dose 1)+ carboplatin + paclitaxel
干预措施: carboplatin (Drug)
SSGJ-707(dose 1)+ carboplatin + paclitaxel
干预措施: paclitaxel (Drug)
SSGJ-707(dose 2)+ carboplatin + paclitaxel
干预措施: SSGJ-707 (Drug)
SSGJ-707(dose 2)+ carboplatin + paclitaxel
干预措施: carboplatin (Drug)
SSGJ-707(dose 2)+ carboplatin + paclitaxel
干预措施: paclitaxel (Drug)
SSGJ-707(dose 3)+ carboplatin + paclitaxel
干预措施: SSGJ-707 (Drug)
SSGJ-707(dose 3)+ carboplatin + paclitaxel
干预措施: carboplatin (Drug)
SSGJ-707(dose 3)+ carboplatin + paclitaxel
干预措施: paclitaxel (Drug)
SSGJ-707(dose 4)+ paclitaxel
干预措施: SSGJ-707 (Drug)
SSGJ-707(dose 4)+ paclitaxel
干预措施: paclitaxel (Drug)
结局指标
主要结局
ORR
时间窗: 12 months
Objective response rate
Safety and tolerability
时间窗: 12 months
Safety and tolerability assessed by incidence and severity of adverse events
次要结局
- PFS(24 months)