drugset / Trial / NCT04330625

Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit From PI3K Inhibitor Therapy (REMD-477)

NCT04330625

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 apelisib and prevent hyperglycemia associated with alpelisib in patients with advanced breast cancer who discontinue alpelisib due to severe hyperglycemia despite appropriate medical management.

Timeline

Start
2020-11-13
Primary completion
2021-05-05
Completion
2021-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Volagidemab Monoclonal antibody Subcutaneous

Indications