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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
REMD-477 will be administered as a subcutaneous injection for three weekly doses
Duke University Medical Center
Durham, North Carolina, United States
Adverse Events
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor
Time frame: 22 days
Serious Adverse Events
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time frame: 22 days
Liver Function Tests (LFT) units per liter (u/L)
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time frame: 22 days
Blood Glucose measurements
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time frame: 22 days
Pulse beats per minute
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time frame: 22 days
breathing Rate breaths per minute
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time frame: 22 days
Fasting Glucose levels
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
Time frame: 22 days
Insulin levels
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
Time frame: 22 days
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