A Phase I/Ib Pilot Study to Determine the Safety and Efficacy of a Human Anti-glucagon Receptor Antibody (REMD-477) in Controlling Severe Hyperglycemia Due to Copanlisib in Patients With Relapsed or Refractory Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- breathing Rate breaths per minute
研究概览
简要总结
REMD-477 (Volagidemab) is a human anti-glucagon receptor antibody. Its proposed mechanism of action in controlling hyperglycemia is by blocking glucagon receptor (GCGR) signaling. In this way, it increases hepatic glucose uptake, decreases hepatic glycogenolysis and gluconeogenesis, increases glycogen synthesis, and ultimately decreases blood glucose levels. This protocol will test the hypotheses that REMD-477 is safe and tolerable in patients with severe hyperglycemia on copanlisib and that it decreases the risk of severe hyperglycemia in patients receiving copanlisib for relapsed refractory lymphoma
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Relapsed or refractory lymphoma (Grade 1, 2, 3A)
- •Received 2 or more prior lines of systemic therapy for lymphoma
- •Experienced glucose >250 mg/dL after copanlisib infusion for treatment of lymphoma
排除标准
- •Evidence of histologic transformation
- •Follicular Lymphoma Grade 3B
- •Active CNS involvement by malignancy
- •Elevated AST or ALT > 5x ULN at Screening
- •Unmanageable sensitivity to mammalian-derived drug preparations, or to humanized or human antibodies; managed sensitivities to agents such as obinutuzumab or rituximab or similar agents are not exclusionary
- •History of drug or alcohol abuse within the last 6 months
- •History or family history of pancreatic neuroendocrine tumors or multiple endocrine neoplasia
- •History or family history of pheochromocytoma
- •Other gastrointestinal, cardiac, renal and CNS (i.e. hypoglycemia unawareness) conditions specific to diabetes that would pose additional risk to subject's safety or interfere with the study evaluation, procedures or completion in the opinion of the treating physician.
- •Female subject is pregnant or breastfeeding.
结局指标
主要结局
breathing Rate breaths per minute
时间窗: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Adverse Events
时间窗: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor
Serious Adverse Events
时间窗: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Liver Function Tests (LFT) units per liter (u/L)
时间窗: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Blood Glucose measurements
时间窗: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Pulse beats per minute
时间窗: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
次要结局
- Fasting Glucose levels(22 days)
- Insulin levels(22 days)