Safety, Tolerability and Pharmacokinetics of EM-I-2024 (NCT07584668) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety, Tolerability and Pharmacokinetics of EM-I-2024
Russia24 participantsStarted 2025-07-30
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women aged 18-75 years inclusive;
* Histologically confirmed diagnosis of a solid tumor;
* Patients in whom surgical intervention is contraindicated;
* Patients with exhausted methods of drug and radiation therapy;
* General health status on the ECOG 0-2 scale;
* Life expectancy of at least 3 months;
* Acceptable indicators of a general blood test: hemoglobin ≥ 90 g/l; absolute number of neutrophils ≥ 1500/mm3; platelet count ≥ 100,000/mm3;
* Glomerular filtration rate calculated according to the formula CKD-EPI\* ≥ 60 ml/min/1.73 m2;
* Quick's prothrombin is more than 55%;
* Acceptable indicators of liver function according to biochemical blood analysis: serum bilirubin \< 1.5 x ULN; AST \< 2.5 x ULN (or \< 5 x ULN in patients with liver metastases); ALT \< 2.5 x ULN (or \< 5 x ULN in patients with liver metastases);
* Since the previous antitumor therapy (chemotherapy, targeted therapy, radiotherapy, immunotherapy) at least 30 days or at least 5 half-lives should elapse before the administration of the investigational drug;
* Patients should recover from any previous surgery, radiotherapy, localized therapy, or systemic therapy to the 1st or lower degree of severity of adverse reactions (with the exception of alopecia or anemia, for which the 2nd degree of severity is allowed);
* Women with preserved reproductive potential (who are not menopausal and have not undergone surgical sterilization) and men who are sexually active should use a reliab…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantitative content of the viral drug in the peripheral blood of patients:
Timeframe: Day -1, Day 0, Day 1, Day 2, Day 3
Trial details
NCT IDNCT07584668
SponsorNational Medical Research Radiological Centre of the Ministry of Health of Russia