NCT05773937招募中1 期
A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
- •Male or female subjects aged 18 to 80 years (including 18 and 80 years).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Phase Ia：Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). Phase Ib：Only local advanced or metastatic UC tumors.
- •Subjects must have received ICIs or GC/GP therapies in the previous treatment.
- •Subjects must submit tumor tissues for test.
- •Life expectancy of ≥ 3 months.
- •Subjects must have measurable disease according to RECIST (version 1.1).
- •Adequate organ functions.
- •Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
- •Subjects are willing to follow study procedures.
排除标准
- •Chemotherapy、radiotherapy or immunotherpy within 14 days prior to the first dose of study drug.
- •Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
- •Major surgery within 28 days prior to first dose of study drug.
- •History of uncontrolled diabetes mellitus.
- •Preexisting peripheral neuropathy Grade ≥
- •Received treatment of ADCs with MMAE payload.
- •Any live vaccines within 4 weeks before first dose of study drug or during the study.
- •Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
- •Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
- •Uncontrolled central nervous system metastases.
- •History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
- •History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
- •Has ocular conditions that may increase the risk of corneal epithelium damage.
- •Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
- •Any P-glycoprotein (P-gp) inducers/inhibitors or CYP3A4 inducers/inhibitors for high and medium effect within 14 days prior to the first dose of study drug.
- •Use of any investigational drug or device within 30 days prior to the first dose of study drug.
- •Conditions or situations which may put the subject at significant risk.
研究组 & 干预措施
9MW2821
Experimental
干预措施: 9MW2821 (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 28 days post last drug administration
次要结局
- Disease Control Rate(Up to 24 months)
- Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)(24 months)
- Objective Response Rate(Up to 24 months)
- Progression Free Survival(Up to 24 months)
- Incidence of Anti-Drug Antibody (ADA)(Up to 24 months)
- Duration of Response(Up to 24 months)
- Time to Response(Up to 24 months)
- Overall Survival(Up to 24 months)
研究者
研究点 (2)
Loading locations...
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