Clinical trial NCT04253223: A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hyperglycemia Drug Induced
Keywords: hyperglycemia
lymphoma
anti-glucagon receptor antibody
glucagon receptor
Volagidemab
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events
timeFrame: 22 days
measure: Serious Adverse Events
timeFrame: 22 days
measure: Liver Function Tests (LFT) units per liter (u/L)
timeFrame: 22 days
measure: Blood Glucose measurements
timeFrame: 22 days
measure: Pulse beats per minute
timeFrame: 22 days
measure: breathing Rate breaths per minute
timeFrame: 22 days
Secondary outcomes:
measure: Fasting Glucose levels
timeFrame: 22 days
measure: Insulin levels
timeFrame: 22 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References: