Actively Recruiting
OH2 Injection in Combination With HX008 for Melanoma.
Led by Binhui Biopharmaceutical Co., Ltd. · Updated on 2025-07-24
60
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase Ib study evaluates the safety and efficacy of OH2 in combination with HX008, an anti-PD-1 antibody, in patients with 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 Combination With HX008 for Melanoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with non-operative stage III or stage IV melanoma confirmed by pathology
- Patients who failed conventional treatments, including PD-1 monotherapy, due to progression or intolerance within 6 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 with expected survival over 3 months
- Prior anti-tumor treatments stopped at least 4 weeks ago (6 weeks if nitroso- or mitomycin-based chemotherapy) and side effects recovered to grade 1
- At least one measurable tumor lesion suitable for intratumoral injection with a longest diameter ≥ 5 mm
- Asymptomatic or treated stable brain metastases without steroid use for at least 4 weeks and stable for 3 months
- Adequate blood counts and organ function within specified limits
- Female participants and their partners agree to use effective contraception during and for 3 months after treatment
- Participants with reproductive organ herpes must have completed treatment at least 3 months prior
- Ability and willingness to provide informed consent and comply with study requirements
You will not qualify if you...
- Severe medical conditions including serious heart disease, cerebrovascular disease, uncontrolled diabetes or hypertension, severe infection, active digestive ulcers, or abnormal immune function
- Planned major surgery during the 28-day screening or study period
- Active infections or unexplained fevers above 38.5°C at screening or before treatment
- Past or present immunodeficiency diseases
- Tumor lesions unsuitable for injection volume of 1 ml
- Pregnant or breastfeeding women
- Use of other experimental or antiviral therapies within 4 weeks before treatment
- Allergy to herpes virus or study drug components
- History of primary uveal melanoma or other cancers within 5 years
- History or current tuberculosis
- Lung diseases such as sudden lung disease, interstitial lung disease, pneumonia, pulmonary fibrosis, or radiation pneumonitis
- Active autoimmune diseases or histories that may relapse, except certain controlled conditions like stable type I diabetes or hypothyroidism
- Need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressants within 14 days before treatment, except low-dose inhaled or topical steroids
- Other conditions deemed unsuitable for participation by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
Research Team
J
JUN GUO, PHD
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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