A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VP301 in Patients With Relapsed or Refractory Multiple Myeloma, Lymphoma, or Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Occurrence of General Toxicity
研究概览
简要总结
This study will test the safety, tolerability, and pharmacokinetics of VP301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors.
详细描述
This study will test the safety, tolerability, and pharmacokinetics of VP301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors. This study will be conducted in two parts:
Dose Escalation - This part will evaluate increasing doses of VP301 to identify the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). The first patient enrolled on the study will receive the lowest dose of VP301. Once this dose is shown to be safe, an additional patient will be enrolled at the next higher dose. Patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the MTD or RP2D is reached.
Dose Expansion - Patients with relapsed myeloma and lymphoma will be enrolled and treated with VP301 at the MTD or RP2D.
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
- •Histologic diagnosis of a refractory solid tumor, refractory myeloma or lymphoma with measurable or evaluable disease
- •Patients must have progressed following all therapies of known, potential clinical benefit, or for whom treatments of known clinical benefit are contraindicated.
- •Adequate kidney, liver, and hematologic function
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
排除标准
- •Active brain metastases and history of leptomeningeal metastases.
- •Myeloma patients with plasmacytoma as only measurable disease
- •Non-secretory myeloma
- •Patients with advanced metastatic, symptomatic, visceral spread who are at risk of life-threatening complications
- •Active or chronic, uncontrolled bacterial, viral, or fungal infection(s)
- •Abnormal ECG
- •Has clinically significant cardiovascular disease
- •Additional active malignancy that may confound the assessment of the study endpoints
- •Pregnancy or lactation
- •Known seropositivity for HIV (human immunodeficiency virus) or active hepatitis B or hepatitis C
研究组 & 干预措施
VP301 (Dose Escalation)
Eligible patients will receive VP301 administered as an IV infusion weekly for 6 weeks then every 2 weeks. Patients will be enrolled into escalating dose levels during the Dose Escalation period of the study.
干预措施: VP301 (Drug)
VP301 (Dose Expansion)
Eligible patients will receive VP301 administered as an IV infusion weekly for 6 weeks then every 2 weeks. Patients will receive the maximum tolerated dose or recommended phase 2 dose during the Dose Expansion period of the study.
干预措施: VP301 (Drug)
结局指标
主要结局
Occurrence of General Toxicity
时间窗: through study completion, an average of 30 months
Incidence of treatment-emergent serious AEs including toxicity and change from baseline in safety parameters
Occurrence of Dose Limiting Toxicity
时间窗: Over the first 21 days of VP301 dosing
Incidence of dose limiting toxicity during cycle 1 of dose escalation
次要结局
- Objective response(through study completion, an average of 30 months)
- Serum concentrations of VP301(through study completion, an average of 30 months)
- Antidrug and neutralizing antibodies(through study completion, an average of 30 months)
- Time to response and duration of response(through study completion, an average of 30 months)
- Progression-free survival(through study completion, an average of 30 months)
- Best response(through study completion, an average of 30 months)