A Study of CodaLytic, an Intratumoral Oncolytic Virus, in Patients With Breast Cancer

NCT05600582 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: CDX-ONC-101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Neoplasms; Neoplasm Metastasis

Keywords

Oncolytic Virotherapy

Outcome Measures

Primary Outcomes (3)

• To assess the Serious Adverse events (SAEs) of CodaLytic administered by intratumoral injection

  To assess the frequency of Serious Adverse events (SAEs) of CodaLytic administered by intratumoral injection at 2-weekly or 4-weekly intervals at doses of 10e7 and 10e8 plaque-forming units (PFU)/mL

  Dosing Period approximately 3 months from first dose

• To assess the Adverse events (AEs) of CodaLytic administered by intratumoral injection

  To assess the frequency of Adverse events (AEs) of CodaLytic administered by intratumoral injection at 2-weekly or 4-weekly intervals at doses of 10e7 and 10e8 plaque-forming units (PFU)/mL

  Dosing Period approximately 3 months from first dose

• To assess the Dose-limiting toxicities (DLTs) of CodaLytic administered by intratumoral injection

  To assess the frequency of Dose-limiting toxicities (DLTs) of CodaLytic administered by intratumoral injection at 2-weekly or 4-weekly intervals at doses of 10e7 and 10e8 plaque-forming units (PFU)/mL

  Dosing Period approximately 3 months from first dose

Secondary Outcomes (4)

• CodaLytic administration impact on tumor response and disease progression: Overall response rate (ORR)

  3 months, 6 months, and 12 months from treatment

• CodaLytic administration impact on tumor response and disease progression: Duration of response (DoR)

  3 months, 6 months, and 12 months from treatment

• CodaLytic administration impact on tumor response and disease progression: Disease control rate (DCR)

  3 months, 6 months, and 12 months from treatment

• CodaLytic administration impact on tumor response and disease progression: Progression-free survival (PFS)

  6 months, and 12 months from treatment

Study Arms (4)

10e7 PFU dose 3 injections

EXPERIMENTAL

10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total)

Biological: CodaLytic

10e7 PFU dose 5 injections

EXPERIMENTAL

10e7 PFU CodaLytic administered intratumorally once every 2 weeks (5 doses total)

Biological: CodaLytic

10e8 PFU dose 3 injections

EXPERIMENTAL

10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total)

Biological: CodaLytic

10e8 PFU dose 5 injections

EXPERIMENTAL

10e8 PFU CodaLytic administered intratumorally once every 2 weeks (5 doses total)

Biological: CodaLytic

Interventions

CodaLytic BIOLOGICAL

CodaLytic is a virotherapeutic product based on the wild-type influenza strain A/California/07/2009

10e7 PFU dose 3 injections; 10e7 PFU dose 5 injections; 10e8 PFU dose 3 injections; 10e8 PFU dose 5 injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women or men with metastatic or inoperable, histologically confirmed breast cancer
• Has no alternative treatment of proven benefit available or has refused treatment
• Expected survival ≥ 3 months
• At least 2 measurable lesions according to RECIST 1.1, without contraindication for repeated injections and core needle biopsies
• Adequate organ function
• Eastern Cooperative Oncology Group performance status of 0 to 2
• Negative pregnancy test, if female
• Agreement to practice a highly effective method of contraception
• Agreement to no sperm donation through 28 days, if male
• Willing to provide consent to perform study procedures

You may not qualify if:

• Pregnant or lactating women
• Anticancer therapy within 3 weeks of dosing
• Known active central nervous system metastases (with some exceptions)
• Presence of a concurrent malignancy for which the natural history or treatment has the potential to interfere with the safety or efficacy assessment of the Investigational Product
• Uncontrolled or severe cardiovascular disease
• Immunodeficiency or use of therapies expected to impair the immune response within thirty (30) days of enrollment or during dosing.
• Ongoing toxicity \> Grade 1 from prior treatment except those which are stable
• History of severe reaction (ie, anaphylaxis) to vaccination or immunotherapy
• Planned radiation to lesions targeted for assessment/injection within 60 days before first dose or any planned radiation during dosing period
• Any condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety, or a participant's ability to give informed consent

Sponsors & Collaborators

• Codagenix, Inc: lead

Study Sites (2)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study participants eligible to participate will be enrolled in each of 4 escalating-dose cohorts and administered intratumoral CodaLytic in the injected lesion during the dosing period as follows: Three (3) doses 4 weeks apart at the low dose, five (5) doses 2 weeks apart at the low dose, three (3) doses 4 weeks apart at the high dose and five (5) doses 2 weeks apart at the high dose.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: January 15, 2023
• Primary Completion: September 30, 2024
• Study Completion: January 30, 2025
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)