OH2 Injection in Combination With HX008 for Melanoma.
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. The non-operative stage III or stage IV malignant tumor patients with clear diagnosis by pathology. 2. Patients who have failed in conventional treatment (including PD-1 monotherapy) (disease progression or intolerance) or who have failed in previously assisted PD-1 monotherapy (last assisted PD-1 treatment relapse or metastasis within 6 months). 3. Patients with Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 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. There is at least one measurable lesion that is suitable for intratumoral injection. The measured tumor focus is defined as the longest diameter ≥ 5 mm. 6. Asymptomatic central nervous system metastasis, or treated asymptomatic br