A Phase Ⅰ/Ⅱ Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Identification of the MTD and /or RP2D of 7MW3711(part 1)
研究概览
简要总结
7MW3711 is an antibody-drug conjugate(ADC) directed to a target wildly expressed on solid tumors. This is an open-label, multicenter, phase 1/2 study to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in subjects with advanced solid tumors.
详细描述
Two parts are included in this study. The part of dose escalation and dose expansion(part 1) will enrolled subjects with advanced solid tumors and is to evaluate the safety and tolerability and to determine the maximum tolerated dose and/or the recommend phase 2 dose(RP2D) of 7MW3711 in subjects 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.
- •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.
- •An archival tumor tissue sample(formalin-fixed paraffin-embedded (FFPE) tumor tissue block or at least 5 unstained slides) or a fresh tissue sample should be provided. If the tissue sample cannot be provided during dose escalation, enrollment into the study is allowed after discussion with the Investigator
- •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 V5.
- •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 chemotherapy, immunotherapy, curative radiation within 3 weeks prior to the first administration or targeted molecular within 2 weeks prior to first administration. have received Chinese patent medicine or Chinese herbs of anti-tumor indications within 1 weeks prior to the first administration.
- •Have received any systemic immunosuppressants within 2 weeks prior to the first administration except for topical corticosteroids.
- •Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.
- •History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening.
- •Pregnant, or nursing females.
研究组 & 干预措施
Dose escalation and dose expansion
All subjects enrolled in the part of dose escalation and dose expansion will receive 7MW3711 by introvenous infusion
干预措施: 7MW3711 for injection (Drug)
Cohort expansion
All subjects enrolled in the part of cohort expansion will be treated by 7MW3711 will receive 7MW3711 by introvenous infusion
干预措施: 7MW3711 for injection (Drug)
结局指标
主要结局
Identification of the MTD and /or RP2D of 7MW3711(part 1)
时间窗: from Day1 to Day21 in cycle1 of part 1
MTD(maximum tolerated dose) and /or RP2D(recommended phase II dose)of 7MW3711(part 1)
evaluation of the incidence of adverse events (AEs) (part 1)
时间窗: approximately up to 16 cycles, 21 days a cycle
Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0
Overall response rate (ORR) evaluated by investigators based on RECIST version 1.1 in selected solid tumors(part 2)
时间窗: approximately up to 2 years
ORR:defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR)
次要结局
- overall response rate (ORR) (part1)(approximately up to 1 year)
- evaluation of the incidence of adverse events (AEs) (part 2)(approximately up to 2 years)
- evaluation of Peak Plasma Concentration (Cmax) of 7MW3711(approximately up to 2 years)
- evaluation of t1/2 of 7MW3711(approximately up to 2 years)
- evaluation of AUC of 7MW3711(approximately up to 2 years)