OH2 Oncolytic Viral Therapy in Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor, Gastrointestinal Cancer

In brief

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.

Key facts

Study ID

NCT03866525

Run by

Binhui Biopharmaceutical Co., Ltd.

People needed

300

Starts

2019-04-02

Expected to finish

2025-08-30

Last updated by the study team

2024-12-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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