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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
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another type of cancer that could affect the safety or effectiveness of the investigational treatment.You have severe heart problems that are not being controlled.You are currently pregnant or breastfeeding.You have had a serious reaction like anaphylaxis to a vaccine or immunotherapy in the past.You have received cancer treatment within the past three weeks.You don't have any other effective treatment options available, or you have chosen not to undergo any other available treatments.
Research Study Groups:
This trial has the following groups:- Group 1: 10e7 PFU dose 3 injections
- Group 2: 10e7 PFU dose 5 injections
- Group 3: 10e8 PFU dose 3 injections
- Group 4: 10e8 PFU dose 5 injections
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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