Virus engineered to fight cancer shows promise in early trial
NCT ID NCT04695327
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a modified virus called TILT-123 in 32 people with advanced solid tumors that had not responded to standard treatments. The virus is designed to infect and kill cancer cells while releasing immune-boosting proteins. The main goal was to check safety and find the right dose, not to measure how well it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TILT-123 (a modified virus that infects and kills cancer cells while releasing immune-boosting proteins)
- What this could lead to
- If successful, this could point toward a new way to treat advanced solid tumors by using a virus to attack cancer and stimulate the immune system.
- What could go wrong
- This is an early, small Phase 1 trial focused on safety, not effectiveness. The virus may not work in all patients or could cause side effects like flu-like symptoms or inflammation.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
32 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
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: * Signed and dated informed consent before any trial-related activities. * Male or female over 18 years of age * Pathologically confirmed refractory or recurrent injectable solid tumor, which cannot be treated with curative intent with available therapies. * Standard therapy has failed, it does not exist, is not available or is unlikely to result in meaningful clinical benefit (as assessed by the investigator). Other appropriate evidence-based therapies have failed or are contraindicated. * Multiple prior therapies (e.g. surgery, chemotherapy, checkpoint inhibitors, kinase inhibitors, biological therapies, hormonal therapies, radiation, etc) are allowed. * At least one tumor (\>14 mm in diameter) must be available for injections and biopsies for correlative analyses. The disease burden must be measurable, but does not need to fulfil RECIST 1.1. * Adequate hepatic and renal functions as following: 1. Platelets \> 75 000/mm3 2. Haemoglobin ≥ 100 g/L. 3. AST and ALT \< 3 x ULN. 4. GFR \>60 ml/min (Cockcroft-Gault formula). 5. Leukocytes (WBC) \> 3,0 6. Bilirubin \<1,5 x ULN 8. Men and women must be willing to use adequate forms of contraception from screening, during the trial, and for a minimum of 90 days after end of treatment, in accordance with the following: <!-- --> 1. Women of childbearing potential: Barrier contraceptive method (i.e. condom) must be used in addition to one of the following methods: Intrauterine device or hormonal contraception (oral contraceptive pills, implant, transdermal patches, vaginal ring or long-acting injections). 2. Women not of childbearing potential: Barrier contraceptive method (i.e. condom) must be used. 3. Men: Barrier contraceptive method (i.e. condom) must be used. * Demonstrated WHO/ECOG performance score of 0-1 at screening. * Life expectancy time longer than 3 months. * Capable of understanding and complying with parameters as outlined in the protocol. Exclusion Criteria: * Use of immunosuppressive medications (corticosteroids or drugs used in treatment of autoimmune disease). Exempted are the following which can be allowed at screening and during the trial: a) replacement corticosteroids if e.g. the patient has adrenal insufficiency after prior immunotherapy b) inhaled and topical treatments c) up to 20 mg per day of prednisone/prednisolone. * Treated with any anti-cancer therapy within 30 days prior to the first virus injection. Anti-cancer therapy is defined as anti-cancer agents (e.g. cytotoxic chemotherapy, immunotherapy, signal-transduction inhibitors, etc) and investigational agents. An investigational agent is any drug or therapy that is currently not approved for use in humans. Continuation of hormonal therapy or use of bone modifying agents (eg. bisphosphonate or denosumab) is allowed if started at least 3 months before. Palliative radiation is not allowed within 14 days of the first virus injection (before or after), but it is allowed after day 15 during the trial treatment period, if deemed necessary by the investigator. * Uncontrolled cardiac or vascular diseases. * History of myocardial infarction or cerebral stroke within the previous 12 months before screening or is not sufficiently recovered from an older infarction or cerebral stroke. * History of severe hepatic dysfunction, hepatitis or HIV. * History of coagulation disorder. * Any other medical condition or laboratory abnormality that in the judgment of the principal investigator, may increase the risk associated with study participation or may interfere with interpretation of study results and /or otherwise make the patient inappropriate for entry into this trial. * Female patients who are pregnant, breastfeeding or intend to become pregnant. * Untreated brain metastases. Treated brain metastases which have not progressed in 3 months prior to screening are allowed. * Previously treated (within 5 years) with any oncolytic or replication deficient adenovirus. * Allergy to ingredients present in the investigational medicinal products (ingredients are listed in the protocol).
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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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Docrates Cancer Center
Helsinki, Uusima, 00180, Finland
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Helsinki University Hospital
Helsinki, Uusima, 00029, Finland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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