AzTrials
AzTrials

Coronary Artery DiseasePhase 1/2EXACTNCT04125732

Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)

A Phase 1/2 study testing AdVEGFXC1 in people with Coronary Artery Disease and Ischemia, run by XyloCor Therapeutics, Inc. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
AdVEGFXC1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
16 sitesUnited States
Study dates
24 Jan 2020to 30 May 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Emory University

    Atlanta, Georgia, 30322

  • The Christ Hospital / The Lindner Research Center

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • Cardiology Research Associates

    Daytona Beach, Florida, 32117

  • Duke University

    Durham, North Carolina, 27710

  • University of Florida

    Gainesville, Florida, 32610

  • Houston Methodist

    Houston, Texas, 77030

  • Texas Heart Institute

    Houston, Texas, 77030

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • University of Washington

    Seattle, Washington, 98195

  • Stanford University

    Stanford, California, 94305

  • James A. Haley VA Medical Center

    Tampa, Florida, 33612

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Phase 1/2 Trial of Direct Administration of AdVEGF-All6A+, a Replication Deficient Adenovirus Vector Expressing a cDNA/Genomic Hybrid of Human VEGF, to the Ischemic Myocardium of Subjects With Angina Pectoris

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).

Read the detailed 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.

Being tested
AdVEGFXC1
Keywords
Refractory angina, Coronary Artery Disease, Gene Therapy
Medical subject headings
Coronary Artery Disease, Ischemia, Cardiovascular Diseases, Heart Diseases, Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdVEGFXC1Biological

    Also called XC001

    AdVEGFXC1 at one of 4 doses

Study groups in NCT04125732
Study groupRoleWhat they receive
AdVEGFXC1 at 1x10^9 vpExperimentalNot described
Receives: Biological: AdVEGFXC1
AdVEGFXC1 at 1x10^10 vpExperimentalNot described
Receives: Biological: AdVEGFXC1
AdVEGFXC1 at 4x10^10 vpExperimentalNot described
Receives: Biological: AdVEGFXC1
AdVEGFXC1 at 1x10^11 vpExperimentalNot described
Receives: Biological: AdVEGFXC1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint (adverse events)

    Safety, as assessed by adverse events and serious adverse events

    Measured: 6 months

Secondary outcomes (4)

  1. Secondary Endpoint (Exercise tolerance test)

    Exercise tolerance test

    Measured: 6 months

  2. Secondary Endpoint (Seattle Angina Questionnaire)

    Seattle Angina Questionnaire

    Measured: 6 months

  3. Secondary Endpoint (Canadian Cardiovascular Society angina class)

    Canadian Cardiovascular Society angina class

    Measured: 6 months

  4. Secondary Endpoint (Angina episodes)

    Angina episodes

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2019
  2. Study start24 Jan 2020
  3. Primary completion31 Jan 2023
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04125732
Sponsor's protocol ID
XC001-1001
Acronym
EXACT
Status last verified
Jan 2024
First submitted
4 Oct 2019
Last updated
30 Jan 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16791287

  • Nakamura K, Henry TD, Traverse JH, Latter DA, Mokadam NA, Answini GA, Williams AR, Sun BC, Burke CR, Bakaeen FG, DiCarli MF, Chaitman BR, Peterson MW, Byrnes DG, Ohman EM, Pepine CJ, Crystal RG, Rosengart TK, Kowalewski E, Koch GG, Dittrich HC, Povsic TJ; EXACT Trial Investigators. Angiogenic Gene Therapy for Refractory Angina: Results of the EXACT Phase 2 Trial. Circ Cardiovasc Interv. 2024 May;17(5):e014054. doi: 10.1161/CIRCINTERVENTIONS.124.014054. Epub 2024 May 2.

    PubMed 38696284

  • Povsic TJ, Henry TD, Traverse JH, Anderson RD, Answini GA, Sun BC, Arnaoutakis GJ, Boudoulas KD, Williams AR, Dittrich HC, Tarka EA, Latter DA, Ohman EM, Peterson MW, Byrnes D, Pepine CJ, DiCarli MF, Crystal RG, Rosengart TK, Mokadam NA. EXACT Trial: Results of the Phase 1 Dose-Escalation Study. Circ Cardiovasc Interv. 2023 Aug;16(8):e012997. doi: 10.1161/CIRCINTERVENTIONS.123.012997. Epub 2023 Jul 28.

    PubMed 37503661

  • Povsic TJ, Henry TD, Ohman EM, Pepine CJ, Crystal RG, Rosengart TK, Reinhardt RR, Dittrich HC, Traverse JH, Answini GA, Mokadam NA. Epicardial delivery of XC001 gene therapy for refractory angina coronary treatment (The EXACT Trial): Rationale, design, and clinical considerations. Am Heart J. 2021 Nov;241:38-49. doi: 10.1016/j.ahj.2021.06.013. Epub 2021 Jul 2.

    PubMed 34224684

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AdVEGFXC1 in people with Coronary Artery Disease and Ischemia, run by XyloCor Therapeutics, Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint (adverse events) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04125732, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in