A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of MC002 in Participants With Locally Advanced/Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 143
- 主要终点
- To assess the Number of patients with Adverse Events (AE)
研究概览
简要总结
The goal of this clinical trial is to learn if ADC drug MC002 works to treat locally advanced/metastatic solid tumors in adults. It will also learn about the safety of MC002. The main questions it aims to answer are:
Does participants tolerate the drug MC002 ? What medical problems do participants have when treating with MC002? Does participants benefit from the MC002
.
Participants will:
Intravenous infusion MC002 every 3 weeks in clinical Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •18 years of age and over, male or female, able to understand and willing to sign the Informed Consent Form (ICF).
- •Life expectancy of 3 month or greater
- •participants with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy.
- •At least one measurable lesion as assessed by RECIST 1.1
- •Adequate organ functions.
- •ECOG Performance Status (PS) of 0-1
排除标准
- •Pregnant or nursing females.Participants who have received chemotherapy, investigational therapy, immunotherapy, or any other antitumor active drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose.
- •Known hypersensitivity to either the drug substances or inactive ingredient
- •Participants who have undergone a bone marrow transplantation, solid organ transplantation, stem cell transplant.
- •Participants with QTc >470 msec.
- •Use of ≥10 mg of prednisone or equivalent dose of steroids per day within 3 months of administration (inhaled, intranasal, intraocular, topical and intraarticular joint injections of corticosteroids are allowed).Participants with a history of HCV infection who have not completed curative anti HCV treatment and whose HCV load is above the limit of quantification. Concurrent HCV treatment is not allowed in the trial.Live viral vaccine therapies within 4 weeks prior to the first dose of study drug.
- •Participants who have received treatment with any herbal or alternative therapies within 7 days prior to the first dose of the study drug.
- •Male and female participants of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception
结局指标
主要结局
To assess the Number of patients with Adverse Events (AE)
时间窗: From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up
Any medical event in a participant which may or may not have a causal relationship with this treatment.
Determination of MTD or RP2D
时间窗: From enrollment until 28 days after last study drug
Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of MC002
次要结局
- Maximum concentration (Cmax)(From enrollment until 28 days after last study drug)
- ADA(From enrollment until 28 after last study drug)
- The time taken to reach the maximum concentration (Tmax)(From enrollment until 28 days after last study drug)
- Area Under Curve (AUC)(From enrollment until 28 days after last study drug)
- Half life (T1/2)(From enrollment until 28 days after last study drug)
- Trough concentration (Cmin)(From enrollment until 28 days after last study drug)