An Open-label, Multicenter Phase II Clinical Study of QLS31905 for Injection Combined With QL2107 Injection and XELOX Regimen in the First-line Treatment of CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- DLT
研究概览
简要总结
This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
详细描述
QLS31905 is a bispecific antibody targeting CD3 and CLDN18.2 independently developed by Qilu Pharmaceutical Co., Ltd.
QL2107 is a biosimilar of pembrolizumab (Keytruda®) developed by Qilu Pharmaceutical Co., Ltd.
This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
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 —（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 gastric or gastroesophageal junction (GEJ) adenocarcinoma 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 gastric or gastroesophageal junction (GEJ) adenocarcinoma.
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 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+QL2107+ XELOX
QLS31905+QL2107+ oxaliplatin + capecitabine
干预措施: QLS31905 for Injection (Drug)
QLS31905+QL2107+ XELOX
QLS31905+QL2107+ oxaliplatin + capecitabine
干预措施: QL2107 Injection (Drug)
QLS31905+QL2107+ XELOX
QLS31905+QL2107+ oxaliplatin + capecitabine
干预措施: Oxaliplatin Injection (Drug)
QLS31905+QL2107+ XELOX
QLS31905+QL2107+ oxaliplatin + capecitabine
干预措施: Capecitabine Tablets (Drug)
结局指标
主要结局
DLT
时间窗: up to 42 days following first dose
Dose Limiting Toxicity，for Dose Escalation Stage
MTD
时间窗: up to 42 days following first dose
Maximum Tolerated Dose，for Dose Escalation Stage.
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
- Number of anti-drug antibody (ADA) Positive Participants(Approximately 24 months)
- DOR (Duration of Response)(Approximately 24 months)
- OS (Overall Survival)(Approximately 24 months)
- Maximum concentration (Cmax)(Approximately 24 months)
- Terminal elimination half-life (T1/2)(Approximately 24 months)
- AE (adverse events)(Approximately 24 months)
- PFS (Progression Free Survival)(Approximately 24 months)