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

June 9, 2021 updated by: Herbert Lyerly, Duke University

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: REMD-477
REMD-477 (human IgG2 anti-glucagon receptor antibody Volagidemab) will be administered as a subcutaneous injection for three weekly doses
Biological: REMD-477
REMD-477 will be administered as a subcutaneous injection for three weekly doses
Other Names:
  • Volagidemab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor
22 days
Serious Adverse Events
Time Frame: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
22 days
Liver Function Tests (LFT) units per liter (u/L)
Time Frame: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
22 days
Blood Glucose measurements
Time Frame: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
22 days
Pulse beats per minute
Time Frame: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
22 days
breathing Rate breaths per minute
Time Frame: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
22 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Glucose levels
Time Frame: 22 days
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
22 days
Insulin levels
Time Frame: 22 days
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
22 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 7, 2020

Primary Completion (ACTUAL)

May 5, 2021

Study Completion (ACTUAL)

May 5, 2021

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00102920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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