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

Duke University

Status and phase: Terminated; Phase 1

Conditions: Hyperglycemia Drug Induced

Treatments: Biological: REMD-477

Study type: Interventional

Funder types: Other

Identifiers

NCT04253223

Pro00102920

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

REMD-477

Experimental group

Description:

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

Treatment:

Biological: REMD-477