Status:
RECRUITING
OH2 Oncolytic Viral Therapy in Solid Tumors
Lead Sponsor:
Binhui Biopharmaceutical Co., Ltd.
Conditions:
Solid Tumor
Gastrointestinal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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, h...
Detailed Description
This is a phase I/II study evaluating the safety and efficacy of OH2 injection in patients with malignant solid tumors. In the phase I dose escalation part, three doses (1x10e6, 1x10e7, 1x10e8 CCID50...
Eligibility Criteria
Inclusion
- 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.
- Participants with a history of HSV infection must have recovered at least 3 months before the study.
- Willing and able to provide written informed consent and comply with the requirements of the study.
Exclusion
- 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.
- Pregnant or lactating female.
- Patients who are receiving any other investigational agents.
- Known immediate or delayed hypersensitivity reaction to HSV.
- Previous malignancy within 5 years prior to study entry.
- Patients with any active autoimmune disease or history of autoimmune disease.
- Concurrent medical condition requiring the use of cortisol (\>10mg/day prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment, except for inhalation or topical corticosteroids no more than 10 mg/day prednisone or equivalent.
- Familial, sociological or geographical conditions that, in the judgment of the investigator, do not permit compliance with the protocol.
Key Trial Info
Start Date :
April 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03866525
Start Date
April 2 2019
End Date
August 30 2025
Last Update
December 20 2024
Active Locations (1)
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1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021