A Multi-center, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 With or Without Chemotheray in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs)
研究概览
简要总结
This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.
详细描述
A Multi-center, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 with or without Chemotheray in Patients With Advanced Solid Tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Life expectancy of at least 3 months as assessed by the Investigator.
- •Phase 1b: Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack of effient standard therapies. Phase 2: Histologically or cytologically confirmed locally advanced or metastatic selected advanced solid tumors.
- •Measurable or evaluable disease by RECIST v1.
- •Have adequate hematopoietic, renal and hepatic functions.
- •Men or women willing to use adequate contraceptive measures throughout the study.
排除标准
- •Have other prior malignancies within 3 years before the first administration.
- •Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases.
- •Have significant, uncontrolled, or active cardiovascular disease.
- •Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration.
- •Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V6.
- •Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV.
- •Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor.
- •Prior treatment with B7-H3 targeted agents.
- •Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.
- •Pregnant, or nursing females.
研究组 & 干预措施
Phase 1b: Safety run-in
Multiple dose levels of 7MW3711 will be explored in combination with JS207 with or without Chemotheray administered intravenously (IV) at a fixed dose as specified in the protocol.
干预措施: 7MW3711 (Drug)
Phase 1b: Safety run-in
Multiple dose levels of 7MW3711 will be explored in combination with JS207 with or without Chemotheray administered intravenously (IV) at a fixed dose as specified in the protocol.
干预措施: JS207 (Drug)
Phase 1b: Safety run-in
Multiple dose levels of 7MW3711 will be explored in combination with JS207 with or without Chemotheray administered intravenously (IV) at a fixed dose as specified in the protocol.
干预措施: Cisplatin (Drug)
Phase 1b: Safety run-in
Multiple dose levels of 7MW3711 will be explored in combination with JS207 with or without Chemotheray administered intravenously (IV) at a fixed dose as specified in the protocol.
干预措施: Carboplatin (Drug)
Phase 2: Dose expansion
7MW3711 will be administered at the selected RDE in combination with JS207 with or without Chemotheray administered IV at a fixed dose as specified in the protocol.
干预措施: 7MW3711 (Drug)
Phase 2: Dose expansion
7MW3711 will be administered at the selected RDE in combination with JS207 with or without Chemotheray administered IV at a fixed dose as specified in the protocol.
干预措施: JS207 (Drug)
Phase 2: Dose expansion
7MW3711 will be administered at the selected RDE in combination with JS207 with or without Chemotheray administered IV at a fixed dose as specified in the protocol.
干预措施: Cisplatin (Drug)
Phase 2: Dose expansion
7MW3711 will be administered at the selected RDE in combination with JS207 with or without Chemotheray administered IV at a fixed dose as specified in the protocol.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs)
时间窗: Up to approximately 2 years
AEs are assessed based on NCI CTCAE v6.0.
Maximum tolerate dose（MTD)
时间窗: Up to approximately 2 years
MTD of 7MW3711
Recommended Expansion Dose (RED)
时间窗: Up to approximately 2 years
RED of 7MW3711
次要结局
- Area Under the Concentration-time Curve (AUC)(Up to approximately 2 years)
- Maximum concentration (Cmax)(Up to approximately 2 years)
- Plasma clearance (CL)(Up to approximately 2 years)
- Half-life (t1/2)(Up to approximately 2 years)
- Time to peak drug concentration (Tmax)(Up to approximately 2 years)
- Investigator-assessed progression-free survival (PFS)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Investigator-assessed disease control rate (DCR)(Up to approximately 2 years)
- Immunogenicity(Up to approximately 2 years)