NCT07348653
尚未招募
1 期
A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of MG2512 Injection in Participants With Advanced Solid Tumors
Shanghai Mabgen Biopharmaceutical Technology Co., Ltd.2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2026年2月1日最近更新:
干预措施MG2512 Injection
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Shanghai Mabgen Biopharmaceutical Technology Co., Ltd.
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Dose limiting toxicity (DLT)
概览
简要总结
This is an open-label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and efficacy of MG2512 injection in participants 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
- •Voluntary participation and written informed consent.
- •18-75 years old, no gender limitation.
- •Eastern Cooperative Oncology Group (ECOG) score: 0-
- •With a life expectancy ≥ 3 months.
- •Patients with recurrent or metastatic solid tumors that have been histologically or cytologically confirmed to be incurable through surgery or radical radiotherapy and chemotherapy, who have experienced disease progression after standard treatment, or have no standard treatment plan, or are not suitable for standard treatment.
- •Be able to provide fresh or archived tumour tissue.
- •At least one measurable lesion according to RECIST v1.
- •Adequate bone marrow reserve and organ function.
- •Contraception is required during the trial.
排除标准
- •Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
- •History of other malignant tumors within 5 years before the first use of the study drug.
- •Uncontrollable tumor-related pain or symptomatic hypercalcemia.
- •Having severe cardiovascular and cerebrovascular diseases.
- •Presence of bleeding symptoms with significant clinical significance within 3 months before the first use of the study drug.
- •Uncontrollable effusion within 2 weeks before the first use of the study drug.
- •Subjects with history of interstitial pneumonia or lung diseases that severely affect lung function.
- •Having a severe infection within 4 weeks before the start of study treatment.
- •History of immunodeficiency, including positive HIV test results; presence of active hepatitis B.
- •Subjects with active pulmonary tuberculosis infection within 1 year before enrollment.
研究组 & 干预措施
MG2512 Injection Group
Experimental
干预措施: MG2512 Injection (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: 3 weeks.
Maximum tolerated dose (MTD)
时间窗: 3 weeks.
Recommended Phase 2 Dose (RP2D)
时间窗: From screening period up to study completion, an average of 1 year.
Adverse events (AEs)
时间窗: From screening period up to study completion, an average of 1 year.
次要结局
- Blood concentration of MG2512 after single and continuous administration(From screening period up to study completion, an average of 1 year.)
- Time to reach maximum plasma concentration (Tmax)(From screening period up to study completion, an average of 1 year.)
- Maximum plasma Concentration (Cmax)(From screening period up to study completion, an average of 1 year.)
- Area under the curve from zero to time t (AUC0-t)(From screening period up to study completion, an average of 1 year.)
- Drug Resistant Antibody (ADA) to MG2512(From screening period up to study completion, an average of 1 year.)
- Objective response rate (ORR)(From screening period up to study completion, an average of 1 year.)
- Disease control rate (DCR)(From screening period up to study completion, an average of 1 year.)
- Progression-free survival (PFS)(From screening period up to study completion, an average of 1 year.)
- Overall survival (OS)(From screening period up to study completion, an average of 1 year.)
研究者
研究点 (2)
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