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Virus Therapy

10e7 PFU dose 3 injections for Cancer

Phase 1

Waitlist Available

Research Sponsored by Codagenix, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, and 12 months from treatment

Awards & highlights

Study Summary

This trial is testing the safety & initial effectiveness of a new virus-based treatment for certain types of breast cancer. Patients will get injections, physicals, imaging, etc. to track outcomes.

Eligible Conditions

Cancer
Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, and 12 months from treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, and 12 months from treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, and 12 months from treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To assess the Adverse events (AEs) of CodaLytic administered by intratumoral injection

To assess the Dose-limiting toxicities (DLTs) of CodaLytic administered by intratumoral injection

To assess the Serious Adverse events (SAEs) of CodaLytic administered by intratumoral injection

Secondary outcome measures

Disease

CodaLytic administration impact on tumor response and disease progression: Duration of response (DoR)

Disease

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: 10e8 PFU dose 5 injectionsExperimental Treatment1 Intervention

10e8 PFU CodaLytic administered intratumorally once every 2 weeks (5 doses total)

Group II: 10e8 PFU dose 3 injectionsExperimental Treatment1 Intervention

10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total)

Group III: 10e7 PFU dose 5 injectionsExperimental Treatment1 Intervention

10e7 PFU CodaLytic administered intratumorally once every 2 weeks (5 doses total)

Group IV: 10e7 PFU dose 3 injectionsExperimental Treatment1 Intervention

10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Codagenix, IncLead Sponsor

7 Previous Clinical Trials

382 Total Patients Enrolled

Media Library

CodaLytic (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05600582 — Phase 1

Cancer Research Study Groups: 10e7 PFU dose 3 injections, 10e7 PFU dose 5 injections, 10e8 PFU dose 3 injections, 10e8 PFU dose 5 injections

Cancer Clinical Trial 2023: CodaLytic Highlights & Side Effects. Trial Name: NCT05600582 — Phase 1

CodaLytic (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05600582 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for enrolment in this research endeavor?

"According to clinicaltrials.gov, this trial is no longer seeking patients for enrollment. Initially posted on the 15th of January 2023 and last revised on October 28 2022, there are 5031 other medical studies currently looking for participants."

Answered by AI

What target outcomes is this trial hoping to realize?

"As per the trial sponsor, Codagenix Inc. aims to measure Serious Adverse Events (SAEs) over a 3 month period following initial dosing. As additional measures, this study will assess Disease Control Rate (DCR), Overall Response Rate (ORR) and Duration of Response (DoR). These parameters are used to gauge any changes in tumor response or disease progression as a result of CodaLytic intratumoral injection administration."

Answered by AI

What deleterious effects might be experienced by individuals who receive 10e7 PFU dose 3 injections?

"The safety of 10e7 PFU dose 3 injections has been rated as a 1 on the scale due to this being Phase 1 trial, and thus there is limited evidence supporting its efficacy or safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CodaLytic, an Intratumoral Oncolytic Virus, in Patients With Breast Cancer

2023. "A Study of CodaLytic, an Intratumoral Oncolytic Virus, in Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05600582.