This phase I/II study evaluates the safety and efficacy of OH2 as single agent or in combination with HX008, an anti-PD-1 antibody, in patients with malignant solid tumors (gastrointestinal cancers, head and neck cancers, soft tissue sarcomas).
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed unresectable or recurrent/metastatic solid tumors.
✓. 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.
✓. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
✓. Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1.
✓. Life expectancy \>3 months.
✓. The patient must have at least one tumor site appropriate for intratumoral injection.
✓. Adequate organ function.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
The dose-limiting toxicities (DLTs) of OH2 injection as single agent and in combination with HX008 in patients with solid tumors
Timeframe: 6 months
2
The maximum-tolerated doses (MTDs) of OH2 injection as single agent and in combination with HX008 in patients with solid tumors
Timeframe: 6 months
3
The biodistribution and biologic effect of OH2 injection
Timeframe: 6 months
4
The anti-tumor activity of OH2 monotherapy and in combination with irinotecan or HX008