Breast NeoplasmsPhase 1NCT05600582
A Study of CodaLytic, an Intratumoral Oncolytic Virus, in Patients With Breast Cancer
A Phase 1 study testing CodaLytic in people with Breast Neoplasms and Neoplasm Metastasis, run by Codagenix, Inc at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis
- What is being tested?
- CodaLytic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2023to 30 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Gabrail Cancer Center
Canton, Ohio, 44718
About this study
Official title: Phase 1 Study of CodaLytic, an Intratumoral Influenza-based Oncolytic Virus, in Patients With Metastatic or Otherwise Inoperable Breast Cancer
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:
Read more
- 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.
Read the detailed description
This study is a Phase 1, open-label, 3+3 dose-escalation, clinical trial to evaluate the safety and preliminary efficacy of CodaLytic in patients with metastatic or otherwise inoperable breast cancer.
After providing informed consent, screened participants will undergo baseline safety assessment and imaging. The Investigator will select an accessible lesion for intratumoral injection of CodaLytic (the injected lesion), and a core needle biopsy sample of this lesion will be obtained for eligible participants to be dosed. The Investigator will also select additional lesions for imaging (target lesions); these target lesions will not be injected or biopsied. If possible, another accessible lesion that is not a target lesion will be selected for biopsy to assess abscopal effect.
Three (3) eligible participants who meet all study inclusion and no exclusion criteria will be enrolled in each of four (4) escalating-dose cohorts and administered intratumoral CodaLytic. Up to 3 additional participants per cohort may be enrolled. During the dosing period, participants will be assessed for adverse events, serious adverse events, and dose-limiting toxicities. A safety review committee will review the safety data through Day 28 for the participants in Cohort 1 before participants are enrolled in Cohorts 2 and 3 and safety data through Day 28 for the participants in Cohorts 2 and 3 before participants are enrolled in Cohort 4. The safety review committee will also meet on an ad hoc basis to review any unexpected safety concerns.
Enrolled participants will be followed for adverse events, serious adverse events, dose-limiting toxicities to assess safety of CodaLytic administration. Biopsy samples of the injected lesion and, if possible, from a noninjected, nontarget lesion will be collected at Week 5. At the end of treatment, imaging will be performed for staging by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, and biopsy samples will be collected. Repeat disease assessment will be performed 4 to 8 weeks after the Month 3/EOT visit if complete response (CR) or partial response (PR) is observed at that visit or if progressive disease (PD) is seen at that visit and the participant has not begun additional cancer treatment. After the treatment period, participants may enroll in other studies or be managed with other treatment modalities as indicated, but follow-up assessments of Investigator-assessed tumor response and anticancer treatments will be recorded at Months 6 and 12.
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Being tested
- CodaLytic
- Keywords
- Oncolytic Virotherapy
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CodaLyticBiological
CodaLytic is a virotherapeutic product based on the wild-type influenza strain A/California/07/2009
| Study group | Role | What they receive |
|---|---|---|
| 10e7 PFU dose 3 injections | Experimental | 10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total) Receives: Biological: CodaLytic |
| 10e7 PFU dose 5 injections | Experimental | 10e7 PFU CodaLytic administered intratumorally once every 2 weeks (5 doses total) Receives: Biological: CodaLytic |
| 10e8 PFU dose 3 injections | Experimental | 10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total) Receives: Biological: CodaLytic |
| 10e8 PFU dose 5 injections | Experimental | 10e8 PFU CodaLytic administered intratumorally once every 2 weeks (5 doses total) Receives: Biological: CodaLytic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Dosing Period approximately 3 months from first dose
Secondary outcomes (4)
CodaLytic administration impact on tumor response and disease progression: Overall response rate (ORR)
To assess the Overall response rate (ORR) for CodaLytic intratumoral administration as a measurement of tumor response and disease progression
Measured: 3 months, 6 months, and 12 months from treatment
CodaLytic administration impact on tumor response and disease progression: Duration of response (DoR)
To assess the Duration of response (DoR) for CodaLytic intratumoral administration as a measurement of tumor response and disease progression
Measured: 3 months, 6 months, and 12 months from treatment
CodaLytic administration impact on tumor response and disease progression: Disease control rate (DCR)
To assess the Disease control rate (DCR) for CodaLytic intratumoral administration as a measurement of tumor response and disease progression
Measured: 3 months, 6 months, and 12 months from treatment
CodaLytic administration impact on tumor response and disease progression: Progression-free survival (PFS)
To assess the Progression-free survival (PFS) for CodaLytic intratumoral administration as a measurement of tumor response and disease progression
Measured: 6 months, and 12 months from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start15 Jan 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Why it stopped: Due to funding decision by the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codagenix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600582
- Sponsor's protocol ID
- CDX-ONC-101
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of CodaLytic, an Intratumoral Influenza-based Oncolytic Virus, in Patients With Metastatic or Otherwise Inoperable Breast Cancer
- ClinicalTrials.gov ID
- NCT05600582
- Acronym / sponsor ID
- CDX-ONC-101
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Keywords
- Oncolytic Virotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to funding decision by the sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Codagenix, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a Phase 1, open-label, 3+3 dose-escalation, clinical trial to evaluate the safety and preliminary efficacy of CodaLytic in patients with metastatic or otherwise inoperable breast cancer.
After providing informed consent, screened participants will undergo baseline safety assessment and imaging. The Investigator will select an accessible lesion for intratumoral injection of CodaLytic (the injected lesion), and a core needle biopsy sample of this lesion will be obtained for eligible participants to be dosed. The Investigator will also select additional lesions for imaging (target lesions); these target lesions will not be injected or biopsied. If possible, another accessible lesion that is not a target lesion will be selected for biopsy to assess abscopal effect.
Three (3) eligible participants who meet all study inclusion and no exclusion criteria will be enrolled in each of four (4) escalating-dose cohorts and administered intratumoral CodaLytic. Up to 3 additional participants per cohort may be enrolled. During the dosing period, participants will be assessed for adverse events, serious adverse events, and dose-limiting toxicities. A safety review committee will review the safety data through Day 28 for the participants in Cohort 1 before participants are enrolled in Cohorts 2 and 3 and safety data through Day 28 for the participants in Cohorts 2 and 3 before participants are enrolled in Cohort 4. The safety review committee will also meet on an ad hoc basis to review any unexpected safety concerns.
Enrolled participants will be followed for adverse events, serious adverse events, dose-limiting toxicities to assess safety of CodaLytic administration. Biopsy samples of the injected lesion and, if possible, from a noninjected, nontarget lesion will be collected at Week 5. At the end of treatment, imaging will be performed for staging by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, and biopsy samples will be collected. Repeat disease assessment will be performed 4 to 8 weeks after the Month 3/EOT visit if complete response (CR) or partial response (PR) is observed at that visit or if progressive disease (PD) is seen at that visit and the participant has not begun additional cancer treatment. After the treatment period, participants may enroll in other studies or be managed with other treatment modalities as indicated, but follow-up assessments of Investigator-assessed tumor response and anticancer treatments will be recorded at Months 6 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 10e7 PFU dose 3 injections | Experimental | Biological: CodaLytic10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total) |
| 10e7 PFU dose 5 injections | Experimental | Biological: CodaLytic10e7 PFU CodaLytic administered intratumorally once every 2 weeks (5 doses total) |
| 10e8 PFU dose 3 injections | Experimental | Biological: CodaLytic10e7 PFU CodaLytic administered intratumorally once every 4 weeks (3 doses total) |
| 10e8 PFU dose 5 injections | Experimental | Biological: CodaLytic10e8 PFU CodaLytic administered intratumorally once every 2 weeks (5 doses total) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CodaLyticCodaLytic is a virotherapeutic product based on the wild-type influenza strain A/California/07/2009 | Biological | 10e7 PFU dose 3 injections, 10e7 PFU dose 5 injections, 10e8 PFU dose 3 injections, 10e8 PFU dose 5 injections |
Primary outcome
To assess the Serious Adverse events (SAEs) of CodaLytic administered by intratumoral injection
Time frame: Dosing Period approximately 3 months from first dose
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
To assess the Adverse events (AEs) of CodaLytic administered by intratumoral injection
Time frame: Dosing Period approximately 3 months from first dose
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
To assess the Dose-limiting toxicities (DLTs) of CodaLytic administered by intratumoral injection
Time frame: Dosing Period approximately 3 months from first dose
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
4 secondary outcomes
CodaLytic administration impact on tumor response and disease progression: Overall response rate (ORR)
Time frame: 3 months, 6 months, and 12 months from treatment
CodaLytic administration impact on tumor response and disease progression: Duration of response (DoR)
Time frame: 3 months, 6 months, and 12 months from treatment
CodaLytic administration impact on tumor response and disease progression: Disease control rate (DCR)
Time frame: 3 months, 6 months, and 12 months from treatment
CodaLytic administration impact on tumor response and disease progression: Progression-free survival (PFS)
Time frame: 6 months, and 12 months from treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CodaLytic in people with Breast Neoplasms and Neoplasm Metastasis, run by Codagenix, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the Serious Adverse events (SAEs) of CodaLytic administered by intratumoral injection (time frame: Dosing Period approximately 3 months from first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.