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Monoclonal Antibodies

REMD-477 for Hyperglycemia

Phase 1
Waitlist Available
Led By Susan Dent, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Locally advanced (not amenable to curative surgery) or metastatic invasive breast cancer
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial will test the safety and tolerability of REMD-477 in patients with severe hyperglycemia who are also taking apelisib. The hope is that REMD-477 will prevent hyperglycemia associated with alpelisib in patients with advanced breast cancer who have to discontinue alpelisib due to severe hyperglycemia.

Eligible Conditions
  • Hyperglycemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Serious Adverse Events

Side effects data

From 2021 Phase 2 trial • 154 Patients • NCT03117998
16%
Upper respiratory tract infection
16%
Headache
12%
Aspartate aminotransferace increased
12%
Nausea
12%
Alanine aminotransferace increased
8%
Hypoglycaemia
8%
Anemia
8%
Cough
8%
Diarrhoea
4%
Oropharyngeal pain
4%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A - 35 mg REMD-477
Part B - 35 mg REMD-477
Part A - 70 mg REMD-477
Part A - Matching Placebo
Part B - Matching Placebo
Part B - 70 mg REMD-477

Trial Design

1Treatment groups
Experimental Treatment
Group I: REMD-477Experimental Treatment1 Intervention
REMD-477 (human IgG2 anti-glucagon receptor antibody Volagidemab) will be administered as a subcutaneous injection for four weekly doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
REMD-477
2021
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,407,833 Total Patients Enrolled
2 Trials studying Hyperglycemia
238 Patients Enrolled for Hyperglycemia
Susan Dent, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
59 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~0 spots leftby Mar 2025