NCT05911984尚未招募1 期
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs) as assessed by CTCAE v5.0
研究概览
简要总结
This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety, tolerability and preliminary efficacy of 9MW3811 in patients with advanced solid tumors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants between 18 and 75 years of age, inclusive.
- •Histologically or cytologically confirmed advanced malignant solid tumors, for which standard therapy does not exist or has proven ineffective or intolerable.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy of ≥ 3 months.
- •Participants must have measurable disease according to RECIST (version 1.1).
- •Adequate organ functions.
- •Sexually active fertile participants, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
排除标准
- •Participants with cancerous meningitis and/or central nervous system metastases with clinical symptoms.
- •History of other active malignant tumor within 3 years prior to screening.
- •Suffering from poorly controlled body cavity effusion.
- •Suffering from active autoimmune disease.
- •History of chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, or other respiratory diseases that require hospitalization within 4 weeks prior to the first dose of study drug.
- •History of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
- •History of other severe or uncontrolled systemic disease, i.e. poorly controlled diabetes.
- •Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- •Major surgery within 28 days prior to the first dose of study drug.
- •Participants with one or more clinically significant positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody or human immunodeficiency virus (HIV) antibody.
- •Participants who have received treatment with biotherapy, endocrine therapy, immunotherapy, or other anti-tumor therapy within 2 weeks prior to the first dose of study drug; Radical radiotherapy received within 3 weeks or palliative radiotherapy received within 2 weeks prior to the first dose of study drug; Received treatment with chemotherapy within 3 weeks prior to the first dose of study drug (6 weeks for nitrosourea or mitomycin); Received treatment with oral fluorouracil or small molecule targeted drugs within 2 weeks or 5 half-lives prior to the first dose of study drug (whichever is shorter); Received treatment with anti-tumor traditional Chinese medicine within 1 week prior to the first dose of study drug; Participated in other clinical trials within 4 weeks prior to the first dose of study drug.
- •Participants who have received systemic treatment with immunosuppressants within 2 weeks prior to the first dose of study drug.
研究组 & 干预措施
9MW3811 Injection
Experimental
干预措施: 9MW3811 Injection (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) as assessed by CTCAE v5.0
时间窗: up to 24 weeks
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Incidence of dose-limiting toxicity (DLT) as assessed by CTCAE v5.0
时间窗: Cycle 1 Day 1 to Cycle 1 Day 21
A DLT is defined as any of the adverse drug reactions listed in the protocol that will be assessed during Cycle 1
次要结局
- Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators(up to 24 weeks)
- Disease Control Rate (DCR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators(up to 24 weeks)
- Duration of Response (DoR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators(up to 24 weeks)
- Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators(up to 24 weeks)
- Maximum Plasma Concentration (Cmax)(up to 24 weeks)
- Time to reach Cmax (Tmax)(up to 24 weeks)
- Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)(up to 24 weeks)
- Terminal elimination half-life (t1/2)(up to 24 weeks)
- Volume of distribution (Vz)(up to 24 weeks)
- Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline(up to 24 weeks)
- AUC from time 0 extrapolated to infinity (AUC0-inf)(up to 24 weeks)
- Terminal elimination rate constant (λz)(up to 24 weeks)
- Apparent clearance (CL)(up to 24 weeks)
研究者
研究点 (1)
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