NCT04253223

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 7, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2021

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

January 28, 2020

Last Update Submit

June 9, 2021

Conditions

Hyperglycemia Drug Induced

Keywords

hyperglycemialymphomaanti-glucagon receptor antibodyglucagon receptorVolagidemab

Outcome Measures

Primary Outcomes (6)

  • Adverse Events

    Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor

    22 days

  • Serious Adverse Events

    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)

    Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase

    22 days

  • Blood Glucose measurements

    Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase

    22 days

  • Pulse beats per minute

    Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase

    22 days

  • breathing Rate breaths per minute

    Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase

    22 days

Secondary Outcomes (2)

  • Fasting Glucose levels

    22 days

  • Insulin levels

    22 days

Study Arms (1)

REMD-477

EXPERIMENTAL

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

Biological: REMD-477

Interventions

REMD-477BIOLOGICAL

REMD-477 will be administered as a subcutaneous injection for three weekly doses

Also known as: Volagidemab
REMD-477

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Evidence of histologic transformation
  • Follicular Lymphoma Grade 3B
  • Active CNS involvement by malignancy
  • Elevated AST or ALT \> 5x ULN at Screening
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

HyperglycemiaLymphoma

Interventions

volagidemab

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2020

First Posted

February 5, 2020

Study Start

April 7, 2020

Primary Completion

May 5, 2021

Study Completion

May 5, 2021

Last Updated

June 11, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)