A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 and/or QL1706 Combination Chemotherapy for the Treatment of CLDN18.2-Positive Advanced Malignant Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
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 voluntarily participate in the study and sign the informed consent form;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- •Expected survival time ≥ 3 months;
- •Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
- •No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
- •Tumor tissue samples determined to be positive for Claudin18.2 by immunohistochemistry (IHC);
- •At least one measurable lesion per RECIST v1.1;
- •Patients with adequate cardiac, liver, renal function, etc.
排除标准
- •History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
- •Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
- •Known central nervous system metastases;
- •Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test; Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
- •Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.
研究组 & 干预措施
QLS31905 + oxaliplatin + capecitabine
Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine.
干预措施: QLS31905 (Drug)
QLS31905 + oxaliplatin + capecitabine
Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine.
干预措施: Oxaliplatin (Drug)
QLS31905 + oxaliplatin + capecitabine
Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine.
干预措施: Capecitabine (Drug)
QL1706 + oxaliplatin + capecitabine
Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine.
干预措施: Oxaliplatin (Drug)
QL1706 + oxaliplatin + capecitabine
Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine.
干预措施: Capecitabine (Drug)
QL1706 + oxaliplatin + capecitabine
Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine.
干预措施: QL1706 (Drug)
QLS31905 + oxaliplatin + capecitabine + QL1706
Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706.
干预措施: QLS31905 (Drug)
QLS31905 + oxaliplatin + capecitabine + QL1706
Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706.
干预措施: Oxaliplatin (Drug)
QLS31905 + oxaliplatin + capecitabine + QL1706
Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706.
干预措施: Capecitabine (Drug)
QLS31905 + oxaliplatin + capecitabine + QL1706
Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706.
干预措施: QL1706 (Drug)
QLS31905 + gemcitabine+cisplatin
Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin.
干预措施: QLS31905 (Drug)
QLS31905 + gemcitabine+cisplatin
Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin.
干预措施: Gemcitabine (Drug)
QLS31905 + gemcitabine+cisplatin
Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin.
干预措施: Cisplatin (Drug)
QL1706 + gemcitabine+cisplatin
Biliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin.
干预措施: Gemcitabine (Drug)
QL1706 + gemcitabine+cisplatin
Biliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin.
干预措施: Cisplatin (Drug)
QL1706 + gemcitabine+cisplatin
Biliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin.
干预措施: QL1706 (Drug)
QLS31905 + gemcitabine+cisplatin+ QL1706
Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706.
干预措施: QLS31905 (Drug)
QLS31905 + gemcitabine+cisplatin+ QL1706
Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706.
干预措施: Gemcitabine (Drug)
QLS31905 + gemcitabine+cisplatin+ QL1706
Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706.
干预措施: Cisplatin (Drug)
QLS31905 + gemcitabine+cisplatin+ QL1706
Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706.
干预措施: QL1706 (Drug)
QLS31905 + standard chemotherapy
Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy recommended by guidelines.
干预措施: QLS31905 (Drug)
QLS31905 + standard chemotherapy
Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy recommended by guidelines.
干预措施: Chemotherapy drug (Drug)
QL1706 + standard chemotherapy
Other solid tumor participants will be treated with QL1706 in combination with standard chemotherapy recommended by guidelines.
干预措施: QL1706 (Drug)
QL1706 + standard chemotherapy
Other solid tumor participants will be treated with QL1706 in combination with standard chemotherapy recommended by guidelines.
干预措施: Chemotherapy drug (Drug)
QLS31905 + standard chemotherapy + QL1706
Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706.
干预措施: QLS31905 (Drug)
QLS31905 + standard chemotherapy + QL1706
Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706.
干预措施: QL1706 (Drug)
QLS31905 + standard chemotherapy + QL1706
Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706.
干预措施: Chemotherapy drug (Drug)
结局指标
主要结局
Objective response rate (ORR)
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)
次要结局
- Overall Survival (OS)(Approximately 24 months)
- Duration of Response (DOR)(Approximately 24 months)
- Progression Free Survival(PFS)(Approximately 24 months)
- Maximum concentration (Cmax)(Approximately 24 months)
- Safety assessed by incidence of serious adverse events (SAE)(Approximately 24 months)
- Safety assessed by Adverse Events (AEs)(Approximately 24 months)
- Number of participants with laboratory value abnormalities(Approximately 24 months)
- Time of the maximum concentration (Tmax)(Approximately 24 months)
- Terminal elimination half-life (T1/2)(Approximately 24 months)
- Clearance (CL)(Approximately 24 months)
- Apparent volume of distribution during the terminal phase (Vz)(Approximately 24 months)
- Number of anti-drug antibody (ADA) Positive Participants(Approximately 24 months)