A Phase II Study to Evaluate the Safety and Efficacy of SSGJ-705 Monotherapy and Combination Therapy in Patients With Advanced HER2-Expressing Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This study was an open-label phase Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Monotherapy and Combination Therapy in patients with advanced HER2-Expressing Solid Tumors.
详细描述
This study includes 2 Parts: Part 1 (705 monotherapy for advanced gastric cancer and breast cancer that have failed standard treatment), and Part 2 (705 in combination with chemotherapy for previously untreated advanced gastric cancer and lung cancer).
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
- •Males and/or females over age
- •Histologically and/or cytologically documented local advanced or metastatic non-Small Cell Lung Cancer（NSCLC），Breast Cancer（BC）or Gastric/Gastroesophageal Junction Cancer （G/GEJC).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Expected survival >3 months.
- •Signed informed consent form.
排除标准
- •Any remaining adverse events (AEs) > grade 1 from prior anti-tumor treatment as per Common Terminology Criteria for Adverse Events（CTCAE） v
- •0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.
- •Pregnant or nursing women or women/men who are ready to give birth.
- •symptomatic central nervous system metastasis.
- •Allergy to other antibody drugs or any excipients in the study drugs.
- •Inadequate organ or bone marrow function.
研究组 & 干预措施
Part 1
advanced gastric cancer and breast cancer that have failed standard treatment
干预措施: SSGJ-705 (Drug)
Part 2
previously untreated advanced gastric cancer and lung cancer
干预措施: PD-1/L1 inhibitor combined with chemotherapy (Drug)
Part 2
previously untreated advanced gastric cancer and lung cancer
干预措施: SSGJ-705 combined with chemotherapy (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 12 months
The primary efficacy end point
Incidence of Treatment-Emergent Adverse Events
时间窗: 12 months
The primary safety end point
Severity of Treatment-Emergent Adverse Events
时间窗: 12 months
The primary safety end point
次要结局
- Progression-Free-Survival (PFS)(24 months)