Using OH2 injection for treating solid tumors and melanoma

Open and Incremental Phase I Clinical Trial of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) in the Treatment of Advanced Solid Tumors

This study is testing if an experimental virus called OH2, alone or with another drug, can help people with advanced solid tumors and melanoma when other treatments haven't worked.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Binhui Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04386967 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of OH2, an oncolytic virus derived from herpes simplex virus type 2, either alone or in combination with Keytruda, an anti-PD-1 antibody, in patients with malignant solid tumors, particularly melanoma. The study aims to determine how well OH2 can replicate in tumors and stimulate an immune response through the delivery of GM-CSF. It includes patients with advanced-stage tumors who have not responded to conventional treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with stage III or IV malignant solid tumors who have not responded to conventional treatments.

Not a fit: Patients with early-stage tumors or those who have not exhausted conventional treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with advanced solid tumors, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies involving oncolytic viruses have shown promising results, indicating potential for success with this novel approach.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jun Guo, PH.D

Conditions Solid Tumor; Melanoma; Oncolytic Virus