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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
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 • NCT0311799816%
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.
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