Clinical trial · Interventional
OH2 Oncolytic Viral Therapy in Solid Tumors
Phase I/II Study of OH2 Injection, an Oncolytic Type 2 Herpes Simplex Virus Expressing Granulocyte Macrophage Colony-Stimulating Factor, in Malignant Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I/II study evaluates the safety and efficacy of OH2 as single agent or in combination with HX008, an anti-PD-1 antibody, in patients with malignant solid tumors (gastrointestinal cancers, head and neck cancers, soft tissue sarcomas). OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OH2 injection, with or without irinotecan or HX008 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation and dose expansion
- description
- A 3+3 dose-escalation strategy is used in the phase 1 part and 3 dose levels (10e6, 10e7 and 10e8 CCID50/mL) of OH2 are assessed as single agent and in combination with HX008. The recommended dose levels are then determined and adopted in the phase 2 part for dose-expansion. In the phase 2 dose-expansion part, OH2 will be delivered as single agent in cohort 1, in combination with irinotecan in cohort 2, in combination with HX008 in cohort 3 and 4. There are no comparator arms for these cohorts.
- interventionNames
- Biological: OH2 injection, with or without irinotecan or HX008
Primary outcomes (4)
- measure
- The dose-limiting toxicities (DLTs) of OH2 injection as single agent and in combination with HX008 in patients with solid tumors
- timeFrame
- 6 months
- description
- Primary outcome of phase 1.
- measure
- The maximum-tolerated doses (MTDs) of OH2 injection as single agent and in combination with HX008 in patients with solid tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed unresectable or recurrent/metastatic solid tumors. 2. The patient must have failed the standard treatment (due to either disease progression or intolerable toxicity) or the standard of care had not been established for the specific condition. 3. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. 4. Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1. 5. Life expectancy \>3 months. 6. The patient must have at least one tumor site appropriate for intratumoral injection. 7. Adequate organ function. 8. Participants of reproductive potential must be willing to use adequate contraception for the course of the study until 3 months after the last dose of any of the drugs in the study. 9. Participants with a history of HSV infection must have recovered at least 3 months before the study. 10. Willing and able to provide written informed consent and comply with the requirements of the study. Exclusion Criteria: 1. Uncontrolled concurrent illness including, but not limited to, severe cardiac disease, cerebralvascular disease, uncontrolled diabetes, uncontrolled hypertension, ongoing or active systemic infection, active peptic ulcer disease. 2. Central nervous system (CNS) metastases with clinical symptoms 3. Active infection or an unexplained fever \> 38.5°C. 4. Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C infection. 5. Pregnant or lactating female. 6. Patients who are receiving any other investigational agents. 7. Known immediate or delayed hypersensitivity reaction to HSV. 8. Previous malignancy within 5 years prior to study entry. 9. Patients with any active autoimmune disease or history of autoimmune disease. 10. Concurrent medical condition requiring the use of cortisol (\>10mg/day prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment, except for inhalation or topical corticosteroids no more than 10 mg/day prednisone or equivalent. 11. Familial, sociological or geographical conditions that, in the judgment of the investigator, do not permit compliance with the protocol.
References
Publications (1)
- DERIVEDWang Y, Jin J, Li Y, Zhou Q, Yao R, Wu Z, Hu H, Fang Z, Dong S, Cai Q, Hu S, Liu B. NK cell tumor therapy modulated by UV-inactivated oncolytic herpes simplex virus type 2 and checkpoint inhibitors. Transl Res. 2022 Feb;240:64-86. doi: 10.1016/j.trsl.2021.10.006. Epub 2021 Oct 29. PMID 34757194