Can a modified herpes virus turn the tide against advanced cancer?
NCT ID NCT04386967
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This early-stage trial is testing an investigational therapy called OH2, a modified herpes simplex virus designed to infect and destroy cancer cells while also stimulating the immune system. The study will evaluate OH2 alone or in combination with the immunotherapy drug pembrolizumab (Keytruda) in people with advanced solid tumors, including melanoma. The main goals are to determine the safety, appropriate dosing, and potential anti-tumor activity of this approach.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OH2 injection, an engineered herpes simplex virus that targets tumors, with or without pembrolizumab (Keytruda)
- What this could lead to
- If successful, this could lead to a new treatment option for advanced solid tumors, potentially improving outcomes for patients who have exhausted standard therapies.
- What could go wrong
- This is an early-phase trial, so the treatment may not be effective or may cause significant side effects. The virus and combination therapy are still experimental.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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44 people
The number who actually took part.
- Started
-
Nov 2018
- Finished
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Jun 2026
- Lead sponsor
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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 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: 1. The non-operative stage III or stage IV malignant tumor patients with clear diagnosis by pathology and/ or cytology; breast cancer, gastrointestinal adenocarcinoma, liver cancer, cervical cancer, malignant melanoma, head and neck tumors, Priority inclusion in soft tissue sarcomas (mainly for melanoma patients at the dose extension phase). 2. The absence of a conventional effective treatment or treatment failure or recurrence by a conventional method. 3. Male or female patients, aged 18 ≤ 75 years (including boundary value), general physical condition score ECOG 0 ≤ 1, expected survival time more than 3 months. 4. Prior anti-tumor treatment (including endocrine, chemical/ radiotherapy,targeted therapy) was over 4 weeks (more than 6 weeks of discontinuation using nitroso-and mitomycin-based chemotherapy) and was recovered to grade 1 from the side effects of prior treatment. 5. Those who have undergone major surgery will have to undergo surgery for four weeks. 6. There is at least one measurable lesion that is suitable for intratumoral injection. According to RECIST version 1.1, it is determined that at least once the CT or MRI examination shows the tumor lesion, it is possible to measure the tumor focus. The measured tumor focus is defined as the longest diameter ≥ 10 mm and the scanning thickness is not more than 5.0 mm. For lymph node lesions, the short diameter is ≥ 15 mm. 7. There is no serious dysfunction of the main organs. 8. (a) WBC≥3.0×109/L,ANC≥2.0×109/L ,PLT≥100×109/L,Hb≥90 g/L; (b) BUN and Scr. were in the upper limit of 1.5 times of the normal value; (c) TBIL≤ 1.5 times the upper limit of the normal value. (d) ALT and AST ≤ 2.5 times the upper limit of normal value; The value of patients with liver metastasis did not exceed 5 times the upper limit of normal value. (e) Coagulation function is normal (PT and APPT are within 1.5 times of the upper limit of normal value). 9. Female subjects and their spouses received effective contraceptives during and within 3 months of treatment. 10. Subjects with herpes in the reproductive organs needed three months after the end of herpes. 11. The informed consent was voluntarily signed and the expected compliance was good. Exclusion Criteria: 1. Severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active digestive tract ulcer, abnormal immune function (including, but not limited to, rheumatoid arthritis, lupus erythematosus, Sjogren's syndrome, etc.). 2. History of primary grape-film melanoma or other malignant tumors in the 3 years prior to treatment. (use of combination drugs only) 3. Past or present immunodeficiency diseases. (use of combination drugs only) 4. Treated with PD-1/PD-L1 or PD-L2 monoantigens or inhibitors that have been used or used in the past. (use of combination drugs only) 5. Autoimmune diseases requiring systemic treatment (e.g. steroids or immunosuppressants) during the first 2 years of treatment, such as autoimmune pneumonia, glomerular nephritis, vasculitis and other symptoms of autoimmune diseases; Except for wind or child asthma. (use of combination drugs only) 6. Have uncontrolled primary or brain metastatic tumors. 7. Suffering from uncontrolled mental illness, infectious diseases. 8. The lesions cannot meet the requirements of injection capacity in the tumor body. 9. Pregnant or lactating women. 10. Other experimental therapies or antiviral therapy are used or are being used within 4 weeks of treatment. 11. Other clinical studies have been taken in the past 4 weeks. 12. Allergy to herpes virus and drug ingredients. 13. The researchers believe that there is any reason why the patient is not suitable to participate in this trial.
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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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Peking University Cancer Hospital
Beijing, Beijing Municipality, 100010, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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