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

Hyperglycemia Drug Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04253223
• Other study ID #: Pro00102920
• Status: Terminated
• Phase: Phase 1
• Start date: April 7, 2020
• Est. completion date: May 5, 2021

Study information

• Verified date: June 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 5, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperglycemia Drug Induced

Intervention

Biological:
• REMD-477
REMD-477 will be administered as a subcutaneous injection for three weekly doses

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor	22 days
Primary	Serious Adverse Events	Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase	22 days
Primary	Liver Function Tests (LFT) units per liter (u/L)	Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase	22 days
Primary	Blood Glucose measurements	Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase	22 days
Primary	Pulse beats per minute	Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase	22 days
Primary	breathing Rate breaths per minute	Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase	22 days
Secondary	Fasting Glucose levels	Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia	22 days
Secondary	Insulin levels	Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia	22 days