Assess the Safety and Tolerability of Various Doses and Dosing Schedules of EnteroMix in Patients With a Histologically Confirmed Solid TumorPhase 1EM-I-2024NCT07584668
Safety, Tolerability and Pharmacokinetics of EM-I-2024
A Phase 1 study testing Two cohorts of patients: intravenous administration and intra-arterial administration with dose escalation of the drug. in people with Assess the Safety and Tolerability of Various Doses and Dosing Schedules of EnteroMix in Patients With a Histologically Confirmed Solid Tumor, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Assess the Safety and Tolerability of Various Doses and Dosing Schedules of EnteroMix in Patients With a Histologically Confirmed Solid Tumor
- What is being tested?
- Two cohorts of patients: intravenous administration and intra-arterial administration with dose escalation of the drug.
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteRussia
- Study dates
- 30 Jul 2025to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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 reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, double barrier method (condom and spermicide, diaphragm and spermicide) during the study and at least 62 days after taking the last dose of the drug;
- The ability to follow the procedures specified in the protocol during the entire study period; The patient's informed consent to participate in the clinical trial.
Who cannot join
- Withdrawal of consent to participate in the study.The development of severe or intolerable AES, which, in the researcher's opinion, make the patient's further participation in the study impossible.
- Detection of HIV infection during the study;
- According to the researcher, further participation in the study is not in the best interests of the patient.
- There is a poor response to the study therapy, expressed by the progression of the disease in accordance with the criteria of RECIST 1.1 (RANO for neuroendocrine tumors) or worsening of clinical symptoms and / or laboratory
- According to the researcher, the patient is not committed to the protocol requirements.
- Deviations from the protocol, which, in the opinion of the sponsor or researcher, require the exclusion of the patient from the study.The onset of pregnancy;
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- The patient was included in the study with a violation of compliance with the inclusion/non-inclusion criteria.
- Loss of contact with the patient for follow-up.
- Death of the patient.
- The decision of the sponsor or researcher for a reason not specified above.
Trial locations and contacts
1 site in 1 country.
Russia1 site
FSBI National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation
Moscow, 117630
About this study
Official title: An Open Single-center Phase I Study on the Safety, Tolerability, and Pharmacokinetics of Enterovirus-based EM-I-2024 in Patients With a Histologically Confirmed Diagnosis of a Solid Tumor
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).
- Being tested
- Two cohorts of patients: intravenous administration and intra-arterial administration with dose escalation of the drug.
- Keywords
- solid tumors, oncolytic viruses, vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative content of the viral drug in the peripheral blood of patients:
Measured: Day -1, Day 0, Day 1, Day 2, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start30 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess the Safety and Tolerability of Various Doses and Dosing Schedules of EnteroMix in Patients With a Histologically Confirmed Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584668
- Sponsor's protocol ID
- EM-I-2024
- Acronym
- EM-I-2024
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Single-center Phase I Study on the Safety, Tolerability, and Pharmacokinetics of Enterovirus-based EM-I-2024 in Patients With a Histologically Confirmed Diagnosis of a Solid Tumor
- ClinicalTrials.gov ID
- NCT07584668
- Acronym / sponsor ID
- EM-I-2024 / EM-I-2024
- Keywords
- solid tumors, oncolytic viruses, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (10 listed)
- Withdrawal of consent to participate in the study.The development of severe or intolerable AES, which, in the researcher's opinion, make the patient's further participation in the study impossible.
- Detection of HIV infection during the study;
- According to the researcher, further participation in the study is not in the best interests of the patient.
- There is a poor response to the study therapy, expressed by the progression of the disease in accordance with the criteria of RECIST 1.1 (RANO for neuroendocrine tumors) or worsening of clinical symptoms and / or laboratory
- According to the researcher, the patient is not committed to the protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | – |
Primary outcome
Quantitative content of the viral drug in the peripheral blood of patients:
Time frame: Day -1, Day 0, Day 1, Day 2, Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Two cohorts of patients: intravenous administration and intra-arterial administration with dose escalation of the drug. in people with Assess the Safety and Tolerability of Various Doses and Dosing Schedules of EnteroMix in Patients With a Histologically Confirmed Solid Tumor, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative content of the viral drug in the peripheral blood of patients: (time frame: Day -1, Day 0, Day 1, Day 2, Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.