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Virus Therapy

10e7 PFU dose 3 injections for Oral Cancers

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
No Placebo-Only Group

Summary

This trial tests CodaLytic, a virus that targets and destroys cancer cells, in patients with advanced breast cancer that can't be surgically removed. The virus is injected into tumors to kill cancer cells and shrink the tumor. Oncolytic viruses are genetically engineered to selectively infect and destroy cancer cells while sparing normal cells, and have shown promise for their safety and efficacy.

Eligible Conditions
  • Oral Cancers
  • Breast Cancer
  • Cancer

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Disease
CodaLytic administration impact on tumor response and disease progression: Duration of response (DoR)
Disease
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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)

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
Oral Cancers Research Study Groups: 10e7 PFU dose 3 injections, 10e7 PFU dose 5 injections, 10e8 PFU dose 3 injections, 10e8 PFU dose 5 injections
Oral Cancers 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
~0 spots leftby Dec 2025
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