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The study will include adult patients of either sex with a histologically confirmed solid tumor who are ineligible for surgery and for whom all available pharmacological and radiotherapeutic options have been exhausted. The choice of drug administration route will depend on the extent of the tumor process. In patients with metastatic disease confirmed by imaging methods (CT/MRI/PET-CT as indicated, with assessment according to RECIST 1.1 criteria for solid tumors and RANO criteria for neuro-oncological tumors), EnteroMix will be administered intravenously. In patients with massive locally advanced disease without distant metastases, or with generalized disease showing an isolated progressive lesion confirmed by imaging methods (CT/MRI/PET-CT as indicated, with assessment according to RECIST 1.1 criteria for solid tumors and RANO criteria for neuro-oncological tumors), EnteroMix will be administered intra-arterially (into the afferent artery of the tumor).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two cohorts of patients: intravenous administration and intra-arterial administration with dose escalation of the drug. | Biological | - Single administration of the investigational drug with dose escalation to determine the optimal dose with respect to safety, pharmacokinetics, and therapeutic effect. EnteroMix will be administered once at three dose levels:
EnteroMix will be administered twice with a 10-day interval (Cohort 2.1 - intravenous, Cohort 2.2 - intra-arterial). - Triple administration of the investigational drug at the optimal dose selected based on the results of the first stage. EnteroMix will be administered three times with a 10-day interval (Cohort 3.1 - intravenous, Cohort 3.2 - intra-arterial). The standard 3+3 design for phase I oncology trials is used. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative content of the viral drug in the peripheral blood of patients: | Day -1, Day 0, Day 1, Day 2, Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FSBI National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation | Moscow | 117630 | Russia |
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