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Virus Therapy
10e7 PFU dose 3 injections for Breast 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
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
- Breast Cancer
- 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
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 moreAwards & 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
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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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