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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04125732
Other study ID # XC001-1001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 24, 2020
Est. completion date May 30, 2023

Study information

Verified date January 2024
Source XyloCor Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).


Description:

This is a Phase 1/2, first-in-human, multicenter, open-label, single arm dose escalation trial of XC001. Approximately 12 subjects (N=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion of the highest tolerated dose with 32 additional subjects. XC001 will be administered by a transthoracic epicardial procedure. Safety will be the focus for the initial 6 months after XC001 administration followed by one safety focused telephone evaluation at Month 12.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date May 30, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Males and females, age 18 to 80 years - Diagnosis of chronic angina due to obstructive coronary artery disease that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft or percutaneous coronary intervention - Angina class II-IV based on Canadian Cardiovascular Society Classification of Angina Pectoris - Adequate hematologic (hemoglobin = 10 g/dL, absolute neutrophil count > 1.2 × 10^3 per µL and platelet count = 75,000 per µL), hepatic (alanine aminotransferase and aspartate aminotransferase = 3 x ULN; total bilirubin = 2 x ULN), and renal function (glomerular filtration rate > 29 mL/minute/1.73 m2) - Adequate birth control if of child-bearing potential - Must be willing and able to provide informed consent Exclusion Criteria: - ST elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI) not requiring revascularization, transmural myocardial infarction or cerebral vascular accident within the past 30 days - New York Heart Association Function Class III or IV or left ventricular ejection fraction < 25% within the 6 weeks prior to the screening visit - HbA1c = 8.5%, SBP <90 or >180 mmHg, DBP >100 mmHg - Other concurrent medical conditions that could jeopardize the safety of the subject or objectives of the study

Study Design


Intervention

Biological:
AdVEGFXC1
AdVEGFXC1 at one of 4 doses

Locations

Country Name City State
United States Lehigh Valley Health Network Allentown Pennsylvania
United States Emory University Atlanta Georgia
United States The Christ Hospital / The Lindner Research Center Cincinnati Ohio
United States University of Cincinnati Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States The Ohio State University Columbus Ohio
United States Cardiology Research Associates Daytona Beach Florida
United States Duke University Durham North Carolina
United States University of Florida Gainesville Florida
United States Houston Methodist Houston Texas
United States Texas Heart Institute Houston Texas
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States University of Washington Seattle Washington
United States Stanford University Stanford California
United States James A. Haley VA Medical Center Tampa Florida
United States MedStar Washington Hospital Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
XyloCor Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stewart DJ, Hilton JD, Arnold JM, Gregoire J, Rivard A, Archer SL, Charbonneau F, Cohen E, Curtis M, Buller CE, Mendelsohn FO, Dib N, Page P, Ducas J, Plante S, Sullivan J, Macko J, Rasmussen C, Kessler PD, Rasmussen HS. Angiogenic gene therapy in patients with nonrevascularizable ischemic heart disease: a phase 2 randomized, controlled trial of AdVEGF(121) (AdVEGF121) versus maximum medical treatment. Gene Ther. 2006 Nov;13(21):1503-11. doi: 10.1038/sj.gt.3302802. Epub 2006 Jun 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Endpoint (adverse events) Safety, as assessed by adverse events and serious adverse events 6 months
Secondary Secondary Endpoint (Exercise tolerance test) Exercise tolerance test 6 months
Secondary Secondary Endpoint (Seattle Angina Questionnaire) Seattle Angina Questionnaire 6 months
Secondary Secondary Endpoint (Canadian Cardiovascular Society angina class) Canadian Cardiovascular Society angina class 6 months
Secondary Secondary Endpoint (Angina episodes) Angina episodes 6 months
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