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
Binhui Biopharmaceutical Co., Ltd.
300 participants
Apr 2, 2019
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- Histologically or cytologically confirmed unresectable or recurrent/metastatic solid tumors.
- 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.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1.
- Life expectancy >3 months.
- The patient must have at least one tumor site appropriate for intratumoral injection.
- Adequate organ function.
- 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.
- Participants with a history of HSV infection must have recovered at least 3 months before the study.
- Willing and able to provide written informed consent and comply with the requirements of the study.
Exclusion Criteria11
- 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.
- Central nervous system (CNS) metastases with clinical symptoms
- Active infection or an unexplained fever > 38.5°C.
- Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C infection.
- Pregnant or lactating female.
- Patients who are receiving any other investigational agents.
- Known immediate or delayed hypersensitivity reaction to HSV.
- Previous malignancy within 5 years prior to study entry.
- Patients with any active autoimmune disease or history of autoimmune disease.
- 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.
- Familial, sociological or geographical conditions that, in the judgment of the investigator, do not permit compliance with the protocol.
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Interventions
OH2: Oncolytic Type 2 Herpes Simplex Virus Irinotecan: cytotoxic agent HX008: anti-PD-1 antibody
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03866525