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Trial record 96 of 126 for:    HSV-2

OH2 Oncolytic Viral Therapy in Solid Tumors

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ClinicalTrials.gov Identifier: NCT03866525
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Wuhan Binhui Biotechnology Co., Ltd.

Brief Summary:

This phase I 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.


Condition or disease Intervention/treatment Phase
Solid Tumor Gastrointestinal Cancer Biological: OH2 injection Drug: HX 008 injection Phase 1

Detailed Description:

The trial is a phase I study evaluating the safety and efficacy of OH2 injection in patients with malignant solid tumors.

In the Phase I dose escalation trial, three doses (1x10e6, 1x10e7, 1x10e8 CCID50/mL) of OH2 as single agent will be tested. 5 treatments of OH2 will be delivered by intratumoral injection. The Phase I dose expansion trial comprises of 3 cohorts. In cohort 1, patients will be treated at the maximum tolerated dose as defined in the Phase I escalation trial. In cohort 2, OH2 will be injected at three doses (1x10e6, 1x10e7, 1x10e8 CCID50/mL) in combination with HX008, an anti-PD-1 antibody, and the first doses of the two anti-tumor agents will be administered on the same day. The treatments in cohort 3 will be identical as in cohort 2, except that the first dose of HX008 will be administered at the time of the third dose of OH2. Blood samples will be collected and radiological imaging will be performed to evaluate safety and efficacy during the trial. Besides, patients will be subjected to cutaneous swabs, and blood/urine/feces sampling to determine virus shedding. Participating patients will be evaluated for objective response rate, progression free survival and overall survival.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of OH2 Injection, an Oncolytic Type 2 Herpes Simplex Virus Expressing Granulocyte Macrophage Colony-Stimulating Factor, in Malignant Solid Tumors
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex

Arm Intervention/treatment
Experimental: Dose escalation
Nine patients with histologically confirmed malignant solid tumors will receive a single dose of the OH2 injection every 2 weeks at one of three dose levels (1x10e6, 1x10e7, 1x10e8 CCID50/mL).
Biological: OH2 injection
Oncolytic Type 2 Herpes Simplex Virus

Experimental: Dose expansion
The Phase I dose expansion trial comprises of 3 cohorts. In cohort 1, patients will be treated at the maximum tolerated dose as defined in the Phase I escalation trial. In cohort 2, OH2 injection will be administered at three doses (1x10e6, 1x10e7, 1x10e8 CCID50/mL) in combination with HX008 injection, an anti-PD-1 antibody, and the first doses of the two anti-tumor agents will be administered on the same day. In cohort 3, the treatments will be identical as in cohort 2, except that the first dose of HX008 will be administered at the time of the third dose of OH2.
Biological: OH2 injection
Oncolytic Type 2 Herpes Simplex Virus

Drug: HX 008 injection
Anti-PD-1 antibody




Primary Outcome Measures :
  1. The dose-limiting toxicity (DLT) of OH2 injection in patients with solid tumors [ Time Frame: 6 months ]
  2. The maximum-tolerated dose (MTD) of OH2 injection in patients with solid tumors [ Time Frame: 6 months ]
  3. The dose-limiting toxicity (DLT) of OH2 injection and HX008 injection in patients with solid tumors [ Time Frame: 6 months ]
  4. The maximum-tolerated dose (MTD) of OH2 injection in combination with HX008 injection in patients with solid tumors [ Time Frame: 6 months ]
  5. The biodistribution of OH2 injection as determined by the concentration of OH2 in blood, urine and feces of participating patients [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The response rate of patients with solid tumors receiving OH2 injection monotherapy [ Time Frame: 2 years ]
    The response rate is defined as percentage of patients achieving a best response of complete response (CR) or partial response (PR) as per RECIST v1.1.

  2. The progression-free survival (PFS) of patients with solid tumors receiving OH2 injection monotherapy [ Time Frame: 2 years ]
    PFS was defined as the time period between the start of OH2 monotherapy and the first documented disease progression or death of any cause.

  3. The response rate of patients with solid tumors receiving OH2 injection in combination with HX008 [ Time Frame: 2 years ]
    The response rate is defined as percentage of patients achieving a best response of complete response (CR) or partial response (PR) as per RECIST v1.1.

  4. The progression-free survival (PFS) of patients with solid tumors receiving OH2 injection in combination with HX008 [ Time Frame: 2 years ]
    PFS was defined as the time period between the start of study treatment and the first documented disease progression or death of any cause.

  5. The immunogenicity of OH2 injection as determined by the detection of antibodies in response to OH2 and GM-CSF [ Time Frame: 2 years ]
    The antibodies to be detected include both IgG and IgM.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed unresectable or recurrent/metastatic solid tumors.
  2. 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.
  3. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  4. Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1.
  5. Life expectancy >3 months.
  6. The patient must have at least one tumor site appropriate for intratumoral injection.
  7. Adequate organ function.
  8. 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.
  9. Participants with a history of HSV infection must have recovered at least 3 months before the study.
  10. Willing and able to provide written informed consent and comply with the requirements of the study.

Exclusion Criteria:

  1. 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.
  2. Central nervous system (CNS) metastases with clinical symptoms
  3. Active infection or an unexplained fever > 38.5°C.
  4. Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C infection.
  5. Pregnant or lactating female.
  6. Patients who are receiving any other investigational agents.
  7. Known immediate or delayed hypersensitivity reaction to HSV.
  8. Previous malignancy within 5 years prior to study entry.
  9. Patients with any active autoimmune disease or history of autoimmune disease.
  10. 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.
  11. Familial, sociological or geographical conditions that, in the judgment of the investigator, do not permit compliance with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866525


Contacts
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Contact: Jing Huang, MD 8610-87788102 huangjingwg@163.com

Locations
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China, Beijing
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Recruiting
Beijing, Beijing, China, 100010
Contact: Bo Zhang, P.HD    86-010-87788113    zh.bo@outlook.com   
Sponsors and Collaborators
Wuhan Binhui Biotechnology Co., Ltd.

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Responsible Party: Wuhan Binhui Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03866525     History of Changes
Other Study ID Numbers: OH2-I-ST-02
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wuhan Binhui Biotechnology Co., Ltd.:
Oncolytic Virus
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases