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Safety, Tolerability and Pharmacokinetics of EM-I-2024

NCT07584668 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-13

No results posted yet for this study

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).

Conditions

  • Assess the Safety and Tolerability of Various Doses and Dosing Schedules of EnteroMix in Patients With a Histologically Confirmed Solid Tumor

Interventions

BIOLOGICAL

Two cohorts of patients: intravenous administration and intra-arterial administration with dose escalation of the drug.

\- 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: * 0.5×10⁶ PFU/kg (Cohort 1.1 - intravenous, Cohort 1.4 - intra-arterial); * 5×10⁶ PFU/kg (Cohort 1.2 - intravenous, Cohort 1.5 - intra-arterial); * 5×10⁷ PFU/kg (Cohort 1.3 - intravenous, Cohort 1.6 - intra-arterial). * Double administration of the investigational drug at the optimal dose selected based on the results of the first stage. 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.

Sponsors & Collaborators

  • National Medical Research Radiological Centre of the Ministry of Health of Russia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584668 on ClinicalTrials.gov