Oncolytic viral therapy for 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

This study is testing a new treatment using a modified virus to see if it can help people with solid tumors, like gastrointestinal cancers, feel better when combined with other therapies.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Binhui Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT03866525 on ClinicalTrials.gov

What this trial studies

This phase I/II study evaluates the safety and efficacy of OH2, an oncolytic virus derived from herpes simplex virus type 2, in patients with malignant solid tumors, including gastrointestinal cancers. The trial consists of a dose escalation phase to determine the maximum tolerated dose (MTD) and a dose expansion phase with four treatment cohorts, some receiving OH2 in combination with other therapies like HX008 and irinotecan. The study also assesses the biodistribution of the virus and monitors adverse events using established criteria.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable or recurrent solid tumors who have failed standard treatments.

Not a fit: Patients with resectable tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel treatment option for patients with advanced solid tumors that have not responded to standard therapies.

How similar studies have performed: Other studies using oncolytic viruses have shown promise, suggesting potential for success with this novel approach.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Jing Huang, MD

Conditions Solid Tumor; Gastrointestinal Cancer; Oncolytic Virus