Status:
COMPLETED
Open Multi-cohort Study of the First Phase of Safety of a Drug Based on Double Recombinant Vaccinia Virus VV-GMCSF-Lact
Lead Sponsor:
"Oncostar" LLC
Collaborating Sponsors:
N.N. Petrov National Medical Research Center of Oncology
Conditions:
Oncolytic Virotherapy
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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.
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05376527
Start Date
May 11 2022
End Date
February 27 2025
Last Update
March 24 2025
Active Locations (1)
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1
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, Russia