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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
OH2 injection, with or without irinotecan or HX008
Biological/VaccineOH2: Oncolytic Type 2 Herpes Simplex Virus Irinotecan: cytotoxic agent HX008: anti-PD-1 antibody
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Dose escalation and dose expansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The dose-limiting toxicities (DLTs) of OH2 injection as single agent and in combination with HX008 in patients with solid tumors
Primary outcome of phase 1.
Time frame
6 months2
The maximum-tolerated doses (MTDs) of OH2 injection as single agent and in combination with HX008 in patients with solid tumors
Primary outcome of phase 1.
Time frame
6 months3
The biodistribution and biologic effect of OH2 injection
Primary outcome of phase 1. The biodistribution of OH2 is evaluated by detection of viral loads in the blood, urine, and saliva. Additionally, the injection sites are swabbed for virus shedding. For the analyses of biologic effects, serum samples are collected for HSV serology assays and assessment of GM-CSF protein and GM-CSF RNA.
Time frame
6 months4
The anti-tumor activity of OH2 monotherapy and in combination with irinotecan or HX008
Primary outcome of phase 2.
Time frame
2 yearsSecondary outcomes
1
The anti-tumor activity of OH2 monotherapy and in combination with HX008
Secondary outcome of phase 1.
Time frame
2 years2
The immunogenicity of OH2
Secondary outcome of phase 1. The immunogenicity of OH2 is evaluated by detection of anti-GM-CSF antibodies in the blood.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov