Oncolytic VirotherapyPhase 1NCT05376527

Open Multi-cohort Study of the First Phase of Safety of a Drug Based on Double Recombinant Vaccinia Virus VV-GMCSF-Lact

A Phase 1 study testing Double Recombinant Vaccinia Virus VV-GMCSF-Lact in people with Oncolytic Virotherapy, run by "Oncostar" LLC at 4 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Purpose of the study is to evaluate the safety, tolerability and pharmacokinetic parameters of the drug based on double recombinant vaccinia virus VV-GMCSF-Lact, in patients with recurrent/refractory metastatic breast cancer in successive cohorts with dose escalation with single and multiple administration. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Oncolytic Virotherapy
What is being tested?: Double Recombinant Vaccinia Virus VV-GMCSF-Lact
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 4 sitesRussia
Study dates: 11 May 2022to 27 Feb 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patients with recurrent and/or metastatic breast cancer, for whom the standard methods of treatment are considered ineffective by the medical commission.
Histologically confirmed progressive / metastatic tumor.
Detectable and measurable tumor foci - at least one measurable tumor site measured by CT (with a diameter more than 1 cm) and at least one tumor site for biopsy.
Body weight index from 18.5 to 30 kg / m2 with body weight from 55 to 100 kg inclusive.
Before inclusion of patients in the study, at least one of the following types of therapy was previously performed:
5.1 previous radiation therapy completed more than 4 weeks ago before the screening visit; 5.2 previous immunotherapy completed more than 4 weeks ago before the screening visit; 5.3 previous hormone therapy completed more than 4 weeks ago before the screening visit; 5.4 previous chemotherapy completed more than 4 months ago before the screening visit.

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The indicator of general status is not more than 2 points according the WHO scale.
Age - 18 years or older.
The level of ALT and AST does not exceed the upper limits of normal values more than 4 times.
Hematological parameters: the number of leukocytes > 3000/µl, platelets > 100000/µl, hemoglobin > 8 g/DL.
Negative result of the PCR test for the presence of SARS-CoV-2 virus RNA on screening.
No signs of SARS at least 14 days before screening.
Patients, 12.1. Not vaccinated against the SARS-CoV-2 coronavirus. OR 12.2. Vaccinated/revaccinated against SARS-CoV-2 coronavirus more than 90 days before the screening visit.
Patient's ability to perform the study procedure and provide written informed consent in accordance with the GCP and local laws.

Who cannot join

Incompatibility of patients with the inclusion criteria mentioned above.
Severe cardiovascular diseases in the past and at the present time (myocardial infarction, hypertension, stroke, phlebothrombosis, coronary insufficiency requiring medical correction, etc.).
Allergic reactions to any pharmacological drugs.
Positive reaction of serological study to HIV, hepatitis B and C, syphilis.
The use of immunosuppressive therapy for 90 days before inclusion in the study.
Myeloproliferative disorders requiring systemic therapy, according to anamnesis.

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Exfoliative skin diseases (e.g. eczema or atopic dermatitis) requiring systemic therapy, according to anamnesis.
Clinically significant renal pathology (bilateral renal artery stenosis, renal artery stenosis in a single kidney, patients undergoing kidney transplantation, clinically significant decrease in sodium, hypo- or hyperglycemia, creatinine exceeding the upper limit of normal values more than 2 times).
Impaired renal function (decreased glomerular filtration rate less than 40 ml / min / 1,73 m2, estimated by the CKD-EPI calculation method).
Absence of adequate venous access, allowing to perform infusion therapy.
The inability of the CT.
Use of drugs or therapies listed in the Prohibited Therapies section.
The need for any vaccination/revaccination during the study.
Mental illness that prevents the patient from understanding the treatment plan.
Persons with alcohol, drug or drug addiction
Pregnancy or breastfeeding, refusal of a reliable method of contraception.
The need to use therapy during the study that is not permitted by this protocol.
Any clinical condition or deviation from normal laboratory and vital signs at screening that, in the opinion of the Investigator, would preclude the safe completion of the study protocol.
Participation in other clinical trials currently or within the last 3 months.
Previous serious systemic reaction or adverse effect from a previous smallpox vaccination.

Trial locations and contacts

4 sites in 1 country.

Russia4 sites

N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation
Moscow, Russia, 115478
National Medical Research Radiological Centre (NMRRC) of the Ministry of Health of the Russian Federation
Obninsk, Russia, 249036
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, Russia, 197758
Oncology Research Center, LLC
Saint Petersburg, Russia, 197758

Other trials in Russia

About this study

Official title: Open Multi-cohort Study of the First Phase of Safety of a Drug Based on Double Recombinant Vaccinia Virus VV-GMCSF-Lact in Patients With Recurrent/Refractory Metastatic Breast Cancer With Single and Multiple Administration

The study provides: determination of the maximum tolerated dose of the drug and the frequency, nature, intensity and duration of adverse events connected with the use of the study drug in escalating doses; detection of dose-limiting toxicity, its severity, duration and reversibility; determination of the profile of virus pharmacokinetics and antivirus antibodies; assessment of the objective response to the treatment.

Stage 1,: The virus drug is administered intratumorally once according to a "3+3" design in the dosage from 1*107 PFU to 10*107 PFU. The frequency of dose-limiting toxicity (DLT) will be evaluated (non-hematological toxicity III degree and above; development of febrile neutropenia and body temperature > 38.3°C more than two days after drug administration; thrombocytopenia III degree and above and/or hemorrhagic complications; repeated increase in ALT and/or AST activity is more than 4 times higher than the normal upper limit).

Escalation to the next level occurs if there is no DLT in the entire cohort under study. The study stops if the incidence of DLT in a cohort of 3 patients is 2 or 3. The maximum tolerated dose (MTD) will be considered the studied dose that is lower than the dose which DLT was determined. Stage 1 assumes randomization of no more than 36 patients.

Stage 2, multiple administration: According to Stage 1 the study will move to the second stage if there will be possibility to study at least one dosage regimen based on the previously studied dose. At Stage 2 two doses in ascending order below the MTD and MTD are planned to be used. Escalation to the next level occurs if no DLT is observed during dosing of the first three patients. If DLT develops and drug administration is discontinued, the patient is not excluded from the study, her drug administration visits are skipped, and she goes through all follow-up visits. The drug will be administered intratumorally 1 time per week for 4 weeks in 3 dosages: MTD and 2 lower dosages. Each cohort will include up to 6 patients in a "3+3" design. It is expected to include up to 24 patients, taking into account the possible inclusion of patients to replace those who left.

Conditions: Oncolytic Virotherapy
Being tested: Double Recombinant Vaccinia Virus VV-GMCSF-Lact
Keywords: vaccinia virus, breast cancer, GMCSF, Lactaptin
Medical subject headings: Vaccinia, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Double Recombinant Vaccinia Virus VV-GMCSF-LactBiological
Intratumoral injections:
1*107 PFU (calculated at minimal ED on mice); 2*107 PFU; 4*107 PFU; 6*107 PFU; 8*107 PFU; 10*107 PFU;

Study groups in NCT05376527
Study group	Role	What they receive
VV-GMCSF-Lact	Experimental	Double Recombinant Vaccinia Virus VV-GMCSF-Lact Receives: Biological: Double Recombinant Vaccinia Virus VV-GMCSF-Lact

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Parameters
Number of participants with: AEs, SAEs, lethal outcomes, AEs of grade 3 and higher severity, AEs leading to withdrawal, AEs related to IP administration, and Dose Limiting Toxicity. The severity of adverse events was assessed according to CTCAE (Common Terminology Criteria for Adverse Events) Version 5.0. National Cancer Institute. 2017.
Measured: 90 days from the data of the last treatment (for Stage 1 up to 107 days from participation in the study; for Stage 2 up to 129 days from participation in the study
Number of Participants With Dose-limiting Toxicity
Dose-limiting toxicity is defined as the occurrence of at least one of the following events following administration of the investigational drug:
1. Grade 3 non-hematologic toxicity according to the CTCAE (excluding alopecia);
2. development of febrile neutropenia (neutrophils <1.0 × 10⁹/L with a single;
3. rise in body temperature >38.3°C or a sustained body temperature >=38°C for more than one hour), or development of a clinically significant systemic infection (a local infection at the site of drug administration or at the biopsy site will not be considered clinically significant); (3) Grade III thrombocytopenia or higher and/or hemorrhagic complications; (4) recurrent or persistent elevation of ALT and/or AST levels to more than 4 times the upper limit of normal.
Measured: plus 3 days to the day of the last treatment for single dose, plus 14 days to the day of the last treatment for multiple doses

Secondary outcomes (1)

Determination of Virus Concentrations in Blood
Determination of maximum virus concentrations in blood.
Measured: up to 216 hours since the last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 202227 Feb 2025

First posted17 May 2022
Study start11 May 2022
Primary completion27 Feb 2025
Study completion27 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Oncolytic VirotherapyStudies 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: Not applicable
Intervention model: Single group
Model description: Open Multi-cohort Study of Safety and Tolerability
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05376527
Sponsor's protocol ID: Oncolact2020
Status last verified: Apr 2026
First submitted: 6 May 2022
Last updated: 21 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
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All Oncolytic Virotherapy trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Multi-cohort Study of the First Phase of Safety of a Drug Based on Double Recombinant Vaccinia Virus VV-GMCSF-Lact in Patients With Recurrent/Refractory Metastatic Breast Cancer With Single and Multiple Administration
ClinicalTrials.gov ID: NCT05376527
Acronym / sponsor ID: Oncolact2020
Conditions: Oncolytic Virotherapy
Keywords: vaccinia virus, breast cancer, GMCSF, Lactaptin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: "Oncostar" LLCIndustry (pharma, biotech, devices)
Collaborators: N.N. Petrov National Medical Research Center of Oncology
Study start: 11 May 2022 (actual)
Primary completion: 27 Feb 2025 (actual)
Study completion: 27 Feb 2025 (actual)
First posted: 17 May 2022 (actual)
Results: Posted 21 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open Multi-cohort Study of Safety and Tolerability

Arm	Type	Receives
VV-GMCSF-Lact	Experimental	Biological: Double Recombinant Vaccinia Virus VV-GMCSF-LactDouble Recombinant Vaccinia Virus VV-GMCSF-Lact

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Female patients with recurrent and/or metastatic breast cancer, for whom the standard methods of treatment are considered ineffective by the medical commission.
Histologically confirmed progressive / metastatic tumor.
Detectable and measurable tumor foci - at least one measurable tumor site measured by CT (with a diameter more than 1 cm) and at least one tumor site for biopsy.
Body weight index from 18.5 to 30 kg / m2 with body weight from 55 to 100 kg inclusive.
Before inclusion of patients in the study, at least one of the following types of therapy was previously performed:

Key exclusion criteria (20 listed)

Incompatibility of patients with the inclusion criteria mentioned above.
Severe cardiovascular diseases in the past and at the present time (myocardial infarction, hypertension, stroke, phlebothrombosis, coronary insufficiency requiring medical correction, etc.).
Allergic reactions to any pharmacological drugs.
Positive reaction of serological study to HIV, hepatitis B and C, syphilis.
The use of immunosuppressive therapy for 90 days before inclusion in the study.

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
Double Recombinant Vaccinia Virus VV-GMCSF-LactIntratumoral injections: 1107 PFU (calculated at minimal ED on mice); 2107 PFU; 4107 PFU; 6107 PFU; 8107 PFU; 10107 PFU;	Biological	VV-GMCSF-Lact

Primary outcome

Safety Parameters
Time frame: 90 days from the data of the last treatment (for Stage 1 up to 107 days from participation in the study; for Stage 2 up to 129 days from participation in the study
Number of participants with: AEs, SAEs, lethal outcomes, AEs of grade 3 and higher severity, AEs leading to withdrawal, AEs related to IP administration, and Dose Limiting Toxicity. The severity of adverse events was assessed according to CTCAE (Common Terminology Criteria for Adverse Events) Version 5.0. National Cancer Institute. 2017.
Number of Participants With Dose-limiting Toxicity
Time frame: plus 3 days to the day of the last treatment for single dose, plus 14 days to the day of the last treatment for multiple doses
Dose-limiting toxicity is defined as the occurrence of at least one of the following events following administration of the investigational drug: 1. Grade 3 non-hematologic toxicity according to the CTCAE (excluding alopecia); 2. development of febrile neutropenia (neutrophils <1.0 × 10⁹/L with a single; 3. rise in body temperature >38.3°C or a sustained body temperature >=38°C for more than one hour), or development of a clinically significant systemic infection (a local infection at the site of drug administration or at the biopsy site will not be considered clinically significant); (3) Grade III thrombocytopenia or higher and/or hemorrhagic complications; (4) recurrent or persistent elevation of ALT and/or AST levels to more than 4 times the upper limit of normal.

1 secondary outcome

Determination of Virus Concentrations in Blood
Time frame: up to 216 hours since the last treatment

Results and safety

Results posted to the registry on 21 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Single Dose 10^7 PFU	4	1
Cohort 2: Single Dose 2 x 10^7 PFU	3	1
Cohort 3: Single Dose 4 x 10^7 PFU	3	2
Cohort 4: Single Dose 6 x 10^7 PFU	3	1
Cohort 5: Single Dose 8 x 10^7 PFU	3	2
Cohort 6: Single Dose 10 x 10^7 PFU	3	1
Cohort 7: Multiple Doses 6 x 10^7 PFU	5	3
Cohort 8: Multiple Doses 8 x 10^7 PFU	6	1
Cohort 9: Multiple Doses 10 x 10^7 PFU	4	1

Primary outcome: Safety Parameters

Time frame: 90 days from the data of the last treatment (for Stage 1 up to 107 days from participation in the study; for Stage 2 up to 129 days from participation in the study. Count of participants. Unit: Participants

Measure	Cohort 1: Single Dose 10^7 PFU n = 4	Cohort 2: Single Dose 2 x 10^7 PFU n = 3	Cohort 3: Single Dose 4 x 10^7 PFU n = 3	Cohort 4: Single Dose 6 x 10^7 PFU n = 3	Cohort 5: Single Dose 8 x 10^7 PFU n = 3	Cohort 6: Single Dose 10 x 10^7 PFU n = 3	Cohort 7: Multiple Doses 6 x 10^7 PFU n = 5	Cohort 8: Multiple Doses 8 x 10^7 PFU n = 6	Cohort 9: Multiple Doses 10 x 10^7 PFU n = 4
Subjects with AEs	4	3	3	3	3	3	5	6	4
Subjects with SAEs	1	0	1	0	0	0	1	0	0
Subjects with lethal outcome	1	0	0	0	0	0	0	0	0
Subjects with AEs of grade 3 and higher severity	1	0	2	3	2	1	2	0	0
Subjects with AEs leading to withdrawal	2	0	0	1	1	1	1	0	0
Subjects with AEs related to IP administration	2	1	2	2	1	1	5	4	2
Subjects with Dose Limiting Toxicity	0	0	0	0	0	0	0	0	0

Primary outcome: Number of Participants With Dose-limiting Toxicity

Time frame: plus 3 days to the day of the last treatment for single dose, plus 14 days to the day of the last treatment for multiple doses. Count of participants. Unit: Participants

Measure	Cohort 1: Single Dose 10^7 PFU n = 4	Cohort 2: Single Dose 2 x 10^7 PFU n = 3	Cohort 3: Single Dose 4 x 10^7 PFU n = 3	Cohort 4: Single Dose 6 x 10^7 PFU n = 3	Cohort 5: Single Dose 8 x 10^7 PFU n = 3	Cohort 6: Single Dose 10 x 10^7 PFU n = 3	Cohort 7: Multiple Doses 6 x 10^7 PFU n = 5	Cohort 8: Multiple Doses 8 x 10^7 PFU n = 6	Cohort 9: Multiple Doses 10 x 10^7 PFU n = 4
Value	0	0	0	0	0	0	0	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Single Dose 10^7 PFU	1 of 4 (25%)	4 of 4 (100%)	1 of 4
Cohort 2: Single Dose 2 x 10^7 PFU	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 3: Single Dose 4 x 10^7 PFU	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Cohort 4: Single Dose 6 x 10^7 PFU	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 5: Single Dose 8 x 10^7 PFU	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 6: Single Dose 10 x 10^7 PFU	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 7: Multiple Doses 6 x 10^7 PFU	1 of 5 (20%)	5 of 5 (100%)	0 of 5
Cohort 8: Multiple Doses 8 x 10^7 PFU	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 9: Multiple Doses 10 x 10^7 PFU	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Petr V. Krivorotko, Professor principal investigator

N.N. Petrov National Medical Research Center of Oncology

4 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 Double Recombinant Vaccinia Virus VV-GMCSF-Lact in people with Oncolytic Virotherapy, run by "Oncostar" LLC at 4 sites in Russia.

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 14 inclusion and 20 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: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Russia. 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?

Yes. Results are posted in the registry (first posted 21 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety Parameters (time frame: 90 days from the data of the last treatment (for Stage 1 up to 107 days from participation in the study; for Stage 2 up to 129 days from participation in the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05376527.

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 21 Apr 2026.