A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 for Injection in Combination With Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- ORR (Objective Response Rate)
研究概览
简要总结
This is an open-label, multicenter Phase II clinical study aimed at evaluating the efficacy, safety, PK profile, and immunogenicity of QLS31905 for Injection combined with Chemotherapy ± QL2107 in Patients with CLDN18.2-positive Advanced Biliary Tract Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subjects with unresectable locally advanced or metastatic Biliary Tract Cancer confirmed by histopathological or cytological examination;
- •Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.
- •Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD;
- •No prior systemic anti-tumor treatment for locally advanced or metastatic Biliary Tract Cancer.
排除标准
- •Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Gemcitabine Hydrochloride for Injection, Cisplatin for Injection, Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations;
- •Subjects had other second primary malignancies within 5 years prior to the first dose;
- •Subjects with clinically significant hemorrhage within 3 months before the first dose;
研究组 & 干预措施
QLS31905 +GP
干预措施: QLS31905 for Injection (Drug)
QLS31905 +GP
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
QLS31905 +GP
干预措施: Cisplatin for Injection (Drug)
QLS31905 +GP+QL2107
干预措施: QLS31905 for Injection (Drug)
QLS31905 +GP+QL2107
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
QLS31905 +GP+QL2107
干预措施: Cisplatin for Injection (Drug)
QLS31905 +GP+QL2107
干预措施: QL2107 Injection (Drug)
QLS31905 +XELOX
干预措施: QLS31905 for Injection (Drug)
QLS31905 +XELOX
干预措施: Oxaliplatin Injection (Drug)
QLS31905 +XELOX
干预措施: Capecitabine Tablets (Drug)
结局指标
主要结局
ORR (Objective Response Rate)
时间窗: Approximately 24 months
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator per RECIST 1.1
次要结局
未报告次要终点