drugset / Trial / NCT04253223

A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib

NCT04253223

Phase 1 Terminated 1 enrolled Duke University
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2020-04-07
Primary completion
2021-05-05
Completion
2021-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Volagidemab Monoclonal antibody Subcutaneous

Indications