A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
详细描述
A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subjects will be enrolled into the study only if they meet all of the following inclusion criteria:
- •Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- •Aged ≥18 years old when sign the ICF, male or female.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1。
- •Life expectancy ≥ 6 months.
- •Subjects must show appropriate organ and marrow function in laboratory examinations
排除标准
- •Subjects will be excluded from the study, if they meet any of the following criteria:
- •A history of other malignant tumors than multiple myeloma within 3 years prior to first dosing
- •Subjects who have severe cardiovascular disease。
- •Use of any live attenuated vaccines within 28 da ys prior to 1st dosing of IMP.
- •Child-bearing potential female who have positive results in pregnancy test or are lactating.
- •Subject who is judged as not eligible to participate in this study by the investigator.
研究组 & 干预措施
LM-305 Dose Escalation
Administered intravenously
干预措施: LM-305 (Drug)
LM-305 Combination Expansion
LM-305 Administered intravenously Dexamethasone Orally
干预措施: LM-305 (Drug)
LM-305 Combination Expansion
LM-305 Administered intravenously Dexamethasone Orally
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: Cycle 1 of each cohort. Duration of one cycle is 21 days
DLT is defined as a toxicity (adverse event at least possibly related to LM305) occurring during the DLT observation period
Adverse Events (AE) and Serious Adverse Events (SAE)
时间窗: From signing the informed consent form (ICF) until 28 days after end of treatment (EOT) or accept other anti-cancer therapy
The safety profile of LM-305 will be assessed by monitoring the adverse events
次要结局
- Area under plasma concentration vs time curve (AUC) for LM-305(Up to finished cycle 5 (each cycle is 21 days))