Actively Recruiting
OH2 Injection in Solid Tumors
Led by Binhui Biopharmaceutical Co., Ltd. · Updated on 2025-07-25
30
Participants Needed
1
Research Sites
420 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I study evaluates the safety and efficacy of OH2 as single agent or in combination with Keytruda, an anti-PD-1 antibody, in patients with malignant solid tumors (Melanoma). 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
Official Title
OH2 Injection in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years with stage III or IV malignant tumors confirmed by pathology or cytology
- Diagnosed with cancers including breast, gastrointestinal adenocarcinoma, liver, cervical, melanoma, head and neck tumors, or soft tissue sarcomas
- No effective conventional treatment available or previous treatment failure or recurrence
- General physical condition ECOG score 0 or 1 and expected survival over 3 months
- Prior anti-tumor treatments stopped at least 4 weeks ago (6 weeks for certain chemotherapies) with recovery to mild or no side effects
- Major surgery must have been at least 4 weeks prior
- At least one measurable tumor lesion suitable for injection, with specified size criteria
- No serious dysfunction of major organs
- Adequate blood counts and organ function within specified limits
- Female participants and their partners agree to use effective contraception during treatment and for 3 months after
- Past genital herpes resolved for at least 3 months
- Signed informed consent and expected good compliance
You will not qualify if you...
- Severe medical diseases like severe heart disease, cerebrovascular disease, uncontrolled diabetes or hypertension, severe infection, active digestive ulcers, or abnormal immune function
- History of primary grape-film melanoma or other malignancies within 3 years
- Past or present immunodeficiency diseases
- Previous treatment with PD-1/PD-L1 or PD-L2 inhibitors when used in combination
- Autoimmune diseases requiring systemic treatment within 2 years, except mild asthma
- Uncontrolled primary or brain metastatic tumors
- Uncontrolled mental illness or infectious diseases
- Tumors not suitable for injection
- Pregnant or lactating women
- Use of other experimental or antiviral therapies within 4 weeks
- Participation in other clinical studies within 4 weeks
- Allergy to herpes virus or drug components
- Any reason judged by researchers that makes participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
Research Team
J
Jun Guo, PH.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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