Virus therapy takes on Hard-to-Treat cancers
NCT ID NCT07584668
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new drug called EM-I-2024, made from a modified enterovirus, in 24 adults with advanced solid tumors that cannot be surgically removed and have not responded to other treatments. The drug is given either intravenously or directly into the artery feeding the tumor, depending on the patient's condition. The main goal is to check safety and find the best dose, while also looking at how the virus behaves in the body and any signs of tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EM-I-2024 (a modified enterovirus)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is a very early, small Phase 1 trial with only 24 participants. The main goal is safety, not effectiveness, so it may not shrink tumors or help patients live longer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. Exclusion Criteria: * 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; * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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FSBI National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation
Moscow, 117630, Russia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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