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

  • STATUS
    Recruiting
  • participants needed
    6
  • sponsor
    Duke University
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Updated on 19 February 2024
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Summary

REMD-477 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

Details
Condition Hyperglycemia Drug Induced
Age 18years - 100years
Treatment REMD-477
Clinical Study IdentifierNCT04253223
SponsorDuke University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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