NCT05416749暂停1 期
Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 216
- 试验地点
- 3
- 主要终点
- AEs
研究概览
简要总结
This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8MW2311 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged≥18 years old;
- •Histologically or cytologically confirmed locally advanced or metastatic solid tumor;
- •Subjects must have measurable disease according to RECIST (version 1.1)；
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
- •Life expectancy >3 months;
- •Adequate organ performance based on laboratory blood tests;
- •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；
- •Ability to understand and the willingness to sign a written informed consent document；
排除标准
- •History of other malignancy within 3 years before the first dose of study drug.
- •History of IL-2 or IL-2 analogues anticancer therapy.
- •Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy within 14 days prior to the first dose of study drug.
- •Major surgery within 28 days prior to first dose of study drug.
- •Any live vaccines within 28 days before first dose of study drug or during the study.
- •Systemic glucocorticoids or other immunosuppressants received within 14 days before first dose of study drug.
- •Toxicity related to preexisting treatment ≥Grade
- •Central nervous system metastasis and/or cancerous meningitis.
- •Inadequately controlled body cavity effusions.
- •Interstitial pneumonia or interstitial lung disease, other pneumonia history or active pneumonia that may interfere with the judgement of immune-related pulmonary toxicity.
- •Active autoimmune disease, or autoimmune diseases history with recurrence possibility.
- •Clinically significant cardiac or cerebrovascular disease.
- •Use of any investigational drug within 28 days prior to the first dose of study drug.
- •Known sensitivity to any of the ingredients of the study drug.
- •Known active hepatitis B or C infection, or other serious infection.
- •History of drug abuse or drug addiction.
- •Pregnancy or lactation.
- •Other disease or condition which may put the subject at significant risk.
研究组 & 干预措施
8MW2311
Experimental
干预措施: 8MW2311 (Drug)
结局指标
主要结局
AEs
时间窗: Up to 28 days post last dose
All the adverse events
ORR
时间窗: Up to 24 months
Objective Response Rate
次要结局
- PK Parameter Cmax(Up to 24 months)
- CBR(Up to 24 months)
- DoR(Up to 24 months)
- TTP(Up to 24 months)
- BOR(Up to 24 months)
- OS(Up to 24 months)
- PFS(Up to 24 months)
- TTR(Up to 24 months)
- PK Parameter Tmax(Up to 24 months)
- Incidence of ADA(Up to 24 months)
- DCR(Up to 24 months)
- PK Parameter AUC(Up to 24 months)
- PK Parameter T1/2(Up to 24 months)
研究者
研究点 (3)
Loading locations...
相似试验
招募中
1 期
A Clinical Study of 9MW2821 in Subjects With Advanced Malignant Solid TumorsSolid TumorsNCT05216965Mabwell (Shanghai) Bioscience Co., Ltd.208
终止
1 期
JSKN033 in Patients With Advanced or Metastatic Solid Malignant TumorsAdvanced Solid TumorNCT06226766Jiangsu Alphamab Biopharmaceuticals Co., Ltd11
招募中
1 期
A Clinical Study of 9MW2821 in Advanced Malignant Solid TumorsAdvanced Malignant Solid TumorsNCT05773937Mabwell (Shanghai) Bioscience Co., Ltd.40
尚未招募
1 期
A Study of DB-1202 Monotherapy in Advanced Solid TumorsAdvanced Solid TumorNCT05785728DualityBio Inc.150
进行中（未招募）
1 期
A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung CancerAdvanced Non-small Cell Lung CancerNCT04818333Jiangsu HengRui Medicine Co., Ltd.157