OH2 Oncolytic Viral Therapy in Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBinhui Biopharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Central nervous system (CNS) metastases with clinical symptoms
Active infection or an unexplained fever > 38.5°C.
Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C infection.
Trial design
Treatments tested in this trial
- OH2 injection, with or without irinotecan or HX008
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov