Clinical Trial

Safety, Tolerability and Pharmacokinetics of EM-I-2024

Study acronym: EM-I-2024
Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
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).
Trial Details
NCT Number NCT07584668
Lead Sponsor National Medical Research Radiological Centre of the Ministry of Health of Russia
Conditions Assess the Safety and Tolerability of Various Doses and Dosing Schedules of EnteroMix in Patients With a Histologically Confirmed Solid Tumor
Enrollment 24 participants
Start Date 2025-07-30
Primary Completion 2026-12 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-05-13