CompletedNCT05376527Updated Apr 21, 2026Results posted

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 interventional study of Double Recombinant Vaccinia Virus VV-GMCSF-Lact in Oncolytic Virotherapy, sponsored by "Oncostar" LLC. Completed at 4 sites in Russia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by "Oncostar" LLC · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 34
Allocation: Not applicable
Ages: 18 Years and older
Sex: Female

Study 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.

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 studied

Oncolytic Virotherapy

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Keywords

vaccinia virus
breast cancer
GMCSF
Lactaptin

In context

Vaccinia

73 studies on the registry are indexed under Vaccinia; 6 are open to participants now.

This study's enrollment of 34 is below the median of 48 across 64 interventional studies indexed under Vaccinia.

Browse Vaccinia studies →

Lead sponsor

This is the only study on the registry with "Oncostar" LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

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.
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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 34 participants (actual)

Study arms

Experimental
VV-GMCSF-Lact
Double Recombinant Vaccinia Virus VV-GMCSF-Lact
Biological: Double Recombinant Vaccinia Virus VV-GMCSF-Lact

Interventions

BiologicalDouble Recombinant Vaccinia Virus VV-GMCSF-Lact
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;

What researchers measure

Primary outcomes

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.
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 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.
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

Secondary outcomes

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

Other outcomes

Determination of the Antivirus Antibodies Titer in the Blood
Determination of the antivirus antibodies titer in the blood 28 days after intratumoral administration.
Time frame: up to 28 days to the last treatment
Assessment of Objective Response
Objective response is defined as per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1): Complete Response - The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Partial Response - At least a 30% decrease in the sum of the longest diameters of target lesions, or all measurable disease has completely disappeared, but a non-measurable component is still present but not progressing. Stable Disease - Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive Disease - At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or new lesions. CT scans were used for visualization.
Time frame: up to 107 days from participation in the study for Stage 1; up to 129 days from participation in the study for Stage 2

Results

Posted Apr 21, 2026

Participant flow

Participant flow — Overall Study
Milestone	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU
Started	4	3	3	3	3	3	5	6	4
Completed	1	1	2	1	2	1	3	1	1
Not completed	3	2	1	2	1	2	2	5	3
Withdrew: Disease progression	1	0	0	1	1	1	1	2	0
Withdrew: Death	1	0	0	0	0	0	0	0	0
Withdrew: Withdrawal by subject	1	1	0	0	0	1	1	2	2
Withdrew: Protocol violation	0	1	1	0	0	0	0	0	0
Withdrew: Adverse event	0	0	0	1	0	0	0	0	0
Withdrew: Requirement of prohibited therapy	0	0	0	0	0	0	0	1	1

Outcome measures

PrimarySafety 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.

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
Reported as:: Count of participants · Participants

Safety Parameters
Participants	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU
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

PrimaryNumber 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.

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
Reported as:: Count of participants · Participants

Number of Participants With Dose-limiting Toxicity
Participants	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU
Number of Participants With Dose-limiting Toxicity	0	0	0	0	0	0	0	0	0

SecondaryDetermination of Virus Concentrations in Blood

Determination of maximum virus concentrations in blood.

Time frame:: up to 216 hours since the last treatment
Reported as:: Median · copies / mL

Determination of Virus Concentrations in Blood
copies / mL	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU
Determination of Virus Concentrations in Blood	0 (0 to 2840)	0 (0 to 533)	564 (0 to 3800)	4110 (0 to 5130)	5950 (5950 to 5950)	2385 (0 to 4770)	11461 (0 to 15690)	3345.5 (880 to 13140)	17060 (17060 to 17060)

Other pre-specifiedDetermination of the Antivirus Antibodies Titer in the Blood

Determination of the antivirus antibodies titer in the blood 28 days after intratumoral administration.

Time frame:: up to 28 days to the last treatment
Reported as:: Geometric mean · Geometric Mean titer

Determination of the Antivirus Antibodies Titer in the Blood
Geometric Mean titer	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU
Determination of the Antivirus Antibodies Titer in the Blood	800 ± 4.2	819200 ± NA	20318.7 ± 119494.2	18101.9 ± 1.3	4525.5 ± 4205470703337.0	409600.0 ± NA	81274.9 ± 3.1	36203.9 ± 8.7	204800.0 ± NA

Other pre-specifiedAssessment of Objective Response

Objective response is defined as per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1): Complete Response - The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Partial Response - At least a 30% decrease in the sum of the longest diameters of target lesions, or all measurable disease has completely disappeared, but a non-measurable component is still present but not progressing. Stable Disease - Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive Disease - At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or new lesions. CT scans were used for visualization.

Time frame:: up to 107 days from participation in the study for Stage 1; up to 129 days from participation in the study for Stage 2
Reported as:: Count of participants · Participants

Assessment of Objective Response
Participants	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU
Complete Response	0	0	0	0	0	0	0	0	0
Partial Response	0	0	0	0	0	0	0	0	0
Stable Disease	1	0	0	1	0	1	1	0	0
Progressive Disease	0	1	1	0	2	0	2	1	1

Adverse events

Collected over Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1: Single Dose 10^7 PFU	1/4 (25%)	1/4 (25%)	4/4 (100%)
Cohort 2: Single Dose 2 x 10^7 PFU	0/3 (0%)	0/3 (0%)	3/3 (100%)
Cohort 3: Single Dose 4 x 10^7 PFU	0/3 (0%)	1/3 (33.3%)	3/3 (100%)
Cohort 4: Single Dose 6 x 10^7 PFU	0/3 (0%)	0/3 (0%)	3/3 (100%)
Cohort 5: Single Dose 8 x 10^7 PFU	0/3 (0%)	0/3 (0%)	3/3 (100%)
Cohort 6: Single Dose 10 x 10^7 PFU	0/3 (0%)	0/3 (0%)	3/3 (100%)
Cohort 7: Multiple Doses 6 x 10^7 PFU	0/5 (0%)	1/5 (20%)	5/5 (100%)
Cohort 8: Multiple Doses 8 x 10^7 PFU	0/6 (0%)	0/6 (0%)	6/6 (100%)
Cohort 9: Multiple Doses 10 x 10^7 PFU	0/4 (0%)	0/4 (0%)	4/4 (100%)

Most frequent serious events

Most frequent serious events
Event	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU
Uterine polypReproductive system and breast disorders	0/4	0/3	1/3	0/3	0/3	0/3	0/5	0/6	0/4
Cancer complicationNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/4	0/3	0/3	0/3	0/3	0/3	0/5	0/6	0/4
Ileus paralyticGastrointestinal disorders	0/4	0/3	0/3	0/3	0/3	0/3	1/5	0/6	0/4

Most frequent other events

Showing 10 of 69

Most frequent other events
Event	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU
PyrexiaGeneral disorders	0/4	0/3	1/3	2/3	1/3	3/3	5/5	4/6	2/4
AnaemiaBlood and lymphatic system disorders	0/4	1/3	0/3	1/3	1/3	2/3	0/5	0/6	0/4
NauseaGastrointestinal disorders	0/4	0/3	2/3	0/3	0/3	0/3	0/5	1/6	0/4
HypertensionVascular disorders	0/4	0/3	0/3	1/3	2/3	0/3	0/5	0/6	0/4
VomitingGastrointestinal disorders	0/4	0/3	2/3	0/3	0/3	0/3	0/5	0/6	0/4
NeutropeniaBlood and lymphatic system disorders	0/4	0/3	0/3	0/3	0/3	0/3	3/5	0/6	0/4
AstheniaGeneral disorders	1/4	1/3	1/3	0/3	0/3	1/3	1/5	3/6	0/4
Body temperature increasedGeneral disorders	2/4	1/3	0/3	0/3	0/3	1/3	0/5	0/6	0/4
HypotensionVascular disorders	0/4	0/3	0/3	1/3	0/3	0/3	2/5	1/6	0/4
PainGeneral disorders	1/4	0/3	1/3	1/3	0/3	1/3	0/5	0/6	0/4

Baseline characteristics

Age, Continuous
Age, Continuous(Year)	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU	Total
Mean	47.25 ± 5.32	52.33 ± 3.21	49.33 ± 12.58	63.67 ± 17.21	59.67 ± 9.71	55.67 ± 12.86	48.6 ± 10.6	54.8 ± 17.8	50.2 ± 5.9	53.50 ± 5.17

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU	Total
Female	4	3	3	3	3	3	5	6	4	34
Male	0	0	0	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0
Asian	0	0	0	0	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0	0	0	0	0
White	4	3	3	3	3	3	5	6	4	34
More than one race	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0

ECOG
ECOG(Participants)	Cohort 1: Single Dose 10^7 PFU	Cohort 2: Single Dose 2 x 10^7 PFU	Cohort 3: Single Dose 4 x 10^7 PFU	Cohort 4: Single Dose 6 x 10^7 PFU	Cohort 5: Single Dose 8 x 10^7 PFU	Cohort 6: Single Dose 10 x 10^7 PFU	Cohort 7: Multiple Doses 6 x 10^7 PFU	Cohort 8: Multiple Doses 8 x 10^7 PFU	Cohort 9: Multiple Doses 10 x 10^7 PFU	Total
ECOG = 0	0	0	0	0	1	0	0	0	0	1
ECOG = 1	3	3	2	1	1	1	5	6	4	26
ECOG = 2	1	0	1	2	1	2	0	0	0	7

Study locations

4 sites

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

References and documents

Study documents

Protocol and statistical analysis plan · Mar 12, 2026

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05376527
Lead sponsor: "Oncostar" LLC
Collaborators: N.N. Petrov National Medical Research Center of Oncology
Responsible party: Sponsor
First posted: May 17, 2022
Start date: May 11, 2022
Primary completion: Feb 27, 2025
Completion: Feb 27, 2025
Results posted: Apr 21, 2026
Last update: Apr 21, 2026

Study contacts

Petr V. Krivorotko, Professor

principal investigator · N.N. Petrov National Medical Research Center of Oncology

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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