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OH2 Injection in Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386967
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
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 Keytruda, an anti-PD-1 antibody, in patients with malignant solid tumors (Melanoma).

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 Melanoma Biological: OH2 injection Drug: Keytruda Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open and Incremental Phase I Clinical Trial of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) in the Treatment of Advanced Solid Tumors
Actual Study Start Date : March 13, 2020
Estimated Primary Completion Date : March 13, 2021
Estimated Study Completion Date : March 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex

Arm Intervention/treatment
Experimental: Dose expansion
Dose expansion trial comprises of 2 cohorts. In cohort 1, OH2 injection will be administered at 1x10e7CCID50/mL . In cohort 2, OH2 injection will be administered at 1x10e7CCID50/mL in combination with Keytruda injection, an anti-PD-1 antibody, and the first doses of the two anti-tumor agents will be administered on the same day.
Biological: OH2 injection
Oncolytic Type 2 Herpes Simplex Virus

Drug: Keytruda
Anti-PD-1 antibody
Other Name: pembrolizumab




Primary Outcome Measures :
  1. Further evaluation of dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of OH2 in patients with solid tumors [ Time Frame: 12 months ]
  2. The dose-limiting toxicity (DLT) of OH2 injection and Keytruda in patients with solid tumors [ Time Frame: 12 months ]
  3. The maximum-tolerated dose (MTD) of OH2 injection in combination with Keytruda in patients with solid tumors [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The response rate of patients with solid tumors receiving OH2 injection monotherapy and OH2 injection in combination with Keytruda [ Time Frame: 12 months ]
  2. The biodistribution of OH2 injection as determined by the concentration of OH2 in blood, urine and feces of participating patients [ Time Frame: 12 months ]
  3. The immunogenicity of OH2 injection as determined by the detection of antibodies in response to OH2 and GM-CSF [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. The non-operative stage III or stage IV malignant tumor patients with clear diagnosis by pathology and/ or cytology; breast cancer, gastrointestinal adenocarcinoma, liver cancer, cervical cancer, malignant melanoma, head and neck tumors, Priority inclusion in soft tissue sarcomas (mainly for melanoma patients at the dose extension phase).
  2. The absence of a conventional effective treatment or treatment failure or recurrence by a conventional method.
  3. Male or female patients, aged 18 ≤ 75 years (including boundary value), general physical condition score ECOG 0 ≤ 1, expected survival time more than 3 months.
  4. Prior anti-tumor treatment (including endocrine, chemical/ radiotherapy,targeted therapy) was over 4 weeks (more than 6 weeks of discontinuation using nitroso-and mitomycin-based chemotherapy) and was recovered to grade 1 from the side effects of prior treatment.
  5. Those who have undergone major surgery will have to undergo surgery for four weeks.
  6. There is at least one measurable lesion that is suitable for intratumoral injection. According to RECIST version 1.1, it is determined that at least once the CT or MRI examination shows the tumor lesion, it is possible to measure the tumor focus. The measured tumor focus is defined as the longest diameter ≥ 10 mm and the scanning thickness is not more than 5.0 mm. For lymph node lesions, the short diameter is ≥ 15 mm.
  7. There is no serious dysfunction of the main organs.
  8. (a) WBC≥3.0×109/L,ANC≥2.0×109/L ,PLT≥100×109/L,Hb≥90 g/L; (b) BUN and Scr. were in the upper limit of 1.5 times of the normal value; (c) TBIL≤ 1.5 times the upper limit of the normal value. (d) ALT and AST ≤ 2.5 times the upper limit of normal value; The value of patients with liver metastasis did not exceed 5 times the upper limit of normal value. (e) Coagulation function is normal (PT and APPT are within 1.5 times of the upper limit of normal value).
  9. Female subjects and their spouses received effective contraceptives during and within 3 months of treatment.
  10. Subjects with herpes in the reproductive organs needed three months after the end of herpes.
  11. The informed consent was voluntarily signed and the expected compliance was good.

Exclusion Criteria:

  1. Severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active digestive tract ulcer, abnormal immune function (including, but not limited to, rheumatoid arthritis, lupus erythematosus, Sjogren's syndrome, etc.).
  2. History of primary grape-film melanoma or other malignant tumors in the 3 years prior to treatment. (use of combination drugs only)
  3. Past or present immunodeficiency diseases. (use of combination drugs only)
  4. Treated with PD-1/PD-L1 or PD-L2 monoantigens or inhibitors that have been used or used in the past. (use of combination drugs only)
  5. Autoimmune diseases requiring systemic treatment (e.g. steroids or immunosuppressants) during the first 2 years of treatment, such as autoimmune pneumonia, glomerular nephritis, vasculitis and other symptoms of autoimmune diseases; Except for wind or child asthma. (use of combination drugs only)
  6. Have uncontrolled primary or brain metastatic tumors.
  7. Suffering from uncontrolled mental illness, infectious diseases.
  8. The lesions cannot meet the requirements of injection capacity in the tumor body.
  9. Pregnant or lactating women.
  10. Other experimental therapies or antiviral therapy are used or are being used within 4 weeks of treatment.
  11. Other clinical studies have been taken in the past 4 weeks.
  12. Allergy to herpes virus and drug ingredients.
  13. The researchers believe that there is any reason why the patient is not suitable to participate in this trial.

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): NCT04386967


Contacts
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Contact: Jun Guo, PH.D 86-010-88140650 guoj307@126.com

Locations
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China, Beijing
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100010
Contact: Jun Guo, P.HD    86-010-88140650    guoj307@126.com   
Sponsors and Collaborators
Wuhan Binhui Biotechnology Co., Ltd.
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Responsible Party: Wuhan Binhui Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04386967    
Other Study ID Numbers: OH2-I-ST-01
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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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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Melanoma
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents