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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

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 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)

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
~0 spots leftby Sep 2024