10e7 PFU dose 5 injections for Metastatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metastatic Cancer+1 MoreCodaLytic - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The goal of this phase 1 open label clinical trial is to evaluate the safety and preliminary efficacy of CodaLytic, an intratumorally-administered oncolytic virus, in patients with metastatic or otherwise inoperable breast cancer. The main questions it aims to answer are: How safe is CodaLytic when administered in escalating dosing groups into targeted lesions? What is the impact of CodaLytic on lesion response and disease progression? Eligible participants will be enrolled into four (4) escalating dose groups and treated with Codalytic through injection into a selected lesion(s) over twelve (12) weeks and then followed for up to one (1) year after the first dose. A safety committee will review the safety profile of each dosing group before the next dose-escalation. Study procedures will include physical examinations, injection site assessments, biopsies, imaging, and collection of blood/urine to assess safety, the body's immune response, and efficacy.

Eligible Conditions
  • Metastatic Cancer
  • Breast Cancer

Treatment Effectiveness

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: 3 months, 6 months, and 12 months from treatment

Month 12
Disease
CodaLytic administration impact on tumor response and disease progression: Duration of response (DoR)
Disease
Month 12
Disease
Month 3
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

Trial Safety

Trial Design

4 Treatment Groups

10e7 PFU dose 5 injections
1 of 4
10e7 PFU dose 3 injections
1 of 4
10e8 PFU dose 3 injections
1 of 4
10e8 PFU dose 5 injections
1 of 4

Experimental Treatment

24 Total Participants · 4 Treatment Groups

Primary Treatment: 10e7 PFU dose 5 injections · No Placebo Group · Phase 1

10e7 PFU dose 5 injections
Biological
Experimental Group · 1 Intervention: CodaLytic · Intervention Types: Biological
10e7 PFU dose 3 injections
Biological
Experimental Group · 1 Intervention: CodaLytic · Intervention Types: Biological
10e8 PFU dose 3 injections
Biological
Experimental Group · 1 Intervention: CodaLytic · Intervention Types: Biological
10e8 PFU dose 5 injections
Biological
Experimental Group · 1 Intervention: CodaLytic · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months, 6 months, and 12 months from treatment

Who is running the clinical trial?

Codagenix, IncLead Sponsor
7 Previous Clinical Trials
358 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Women or men with metastatic or inoperable, histologically confirmed breast cancer.
You have at least 2 measurable lesions according to RECIST 1.
You have normal organ function.