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

Phase 1

Terminated

• Conditions: Hyperglycemia Drug Induced
• Interventions: Biological: REMD-477

• Registration Number: NCT04253223
• Lead Sponsor: Duke University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Study Start: 2020-04-07
• Primary Completion: 2021-05-05
• Study Completion: 2021-05-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
REMD-477	REMD-477	REMD-477 (human IgG2 anti-glucagon receptor antibody Volagidemab) will be administered as a subcutaneous injection for three weekly doses

Primary Outcome Measures

Name	Time	Method
breathing Rate breaths per minute	22 days	Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Adverse Events	22 days	Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor
Serious Adverse Events	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)	22 days	Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Blood Glucose measurements	22 days	Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Pulse beats per minute	22 days	Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase

Secondary Outcome Measures

Name	Time	Method
Fasting Glucose levels	22 days	Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
Insulin levels	22 days	Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States